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  • Comparison of the Nancy index with continuous Geboes score: histological remission and response in ulcerative colitis
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-22
    Magro F, , Lopes J, et al.

    Background and AimsEvidence have been supporting that histological activity of ulcerative colitis [UC] has relevance for the prediction of clinical outcomes in UC patients, such as clinical relapse. In this study, we aimed to compare two histological indexes – the continuous Geboes score [GS] and the Nancy index [NI] – regarding their definitions of histological remission and response, and to determine the ability of fecal calprotectin [FC] levels to discriminate between these histological statuses according to the NI. MethodsA large cohort of UC patients [N=422] that was previously enrolled in other studies was analyzed. ResultsGS and NI were shown to be strongly correlated [correlation coefficient: 0.882, p < 0.001], indicating high accordance in the classification of patients as having/not having histological remission and response. FC levels moderately correlated with NI regarding these histological statuses [correlation coefficient: 0.481, p < 0.001], moderately predicted the absence of remission defined by NI > 0 [area under the curve (AUC) 0.667 (95% CI 0.609-0.724)], and were good predictors of the absence of histological response defined by NI > 1 [AUC 0.825 (95% CI 0.777-0.872)]. The optimal FC cut-offs determined to predict the NI-defined histological remission and response were 91 μg/g and 106 μg/g, when maximizing the negative predictive value [NPV]. ConclusionsDue to the higher applicability of the NI, this study encourages the systematic use of this histological index to assess histological remission and response in UC patients.

    更新日期:2020-01-23
  • Progress in the Molecular and Histological Dissection of Crohn’s Disease-associated Small Bowel Adenocarcinomas
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-13
    Carbonnel F, Svrcek M.

    Patients with inflammatory bowel diseases are exposed to an increased risk of intestinal cancer. Colorectal cancer associated with ulcerative colitis [UC] has been extensively studied. The main risk factors are longstanding evolution, lack of endoscopic and histological healing, extent of inflammation along the colon, and primary sclerosing cholangitis. In patients with UC, colorectal carcinogenesis follows an inflammation-dysplasia-cancer sequence. Epithelial dysplasia precedes colorectal cancer and both have specific molecular, histological, and endoscopic characteristics. Colorectal screening in patients with UC is based upon endoscopic diagnosis of dysplasia followed by endoscopic resection or colectomy.1

    更新日期:2020-01-22
  • Imaging Findings of Ileal Inflammation at Computed Tomography and Magnetic Resonance Enterography: What do They Mean When Ileoscopy and Biopsy are Negative?
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-21
    Nehra A, Sheedy S, Wells M, et al.

    Background and AimsOur goal was to determine the importance of ileal inflammation at computed tomography or magnetic resonance enterography in Crohn’s disease patients with normal ileoscopy. MethodsPatients with negative ileoscopy and biopsy within 30 days of CT or MR enterography showing ileal inflammation were included. The severity [0–3 scale] and length of inflammation within the distal 20 cm of the terminal ileum were assessed on enterography. Subsequent medical records were reviewed for ensuing surgery, ulceration at ileoscopy, histological inflammation, or new or worsening ileal inflammation or stricture on enterography. Imaging findings were classified as: Confirmed Progression [subsequent surgery or radiological worsening, new ulcers at ileoscopy or positive histology]; Radiologic Response [decreased inflammation with medical therapy]; or Unlikely/Unconfirmed Inflammation. ResultsOf 1471 patients undergoing enterography and ileoscopy, 112 [8%] had imaging findings of inflammation with negative ileoscopy, and 88 [6%] had negative ileoscopy and ileal biopsy. Half [50%; 44/88] with negative biopsy had moderate/severe inflammation at enterography, with 45%, 32% and 11% having proximal small bowel inflammation, stricture or fistulas, respectively. Two-thirds with negative biopsy [67%; 59/88] had Confirmed Progression, with 68%, 70% and 61% having subsequent surgical resection, radiological worsening or ulcers at subsequent ileoscopy, respectively. Mean length and severity of ileal inflammation in these patients was 10 cm and 1.6. Thirteen [15%] patients had Radiologic Response, and 16 [18%] had Unlikely/Unconfirmed Inflammation. ConclusionCrohn’s disease patients with unequivocal imaging findings of ileal inflammation at enterography despite negative ileoscopy and biopsy are likely to have active inflammatory Crohn’s disease. Disease detected by imaging may worsen over time or respond to medical therapy.

    更新日期:2020-01-22
  • P662 Efficacy and safety of tofacitinib in patients with moderate-to-severe ulcerative colitis: A real-world retrospective study
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Yoshimura N, Okano S, Sako M, et al.

    BackgroundTofacitinib is an orally active, small-molecule Janus kinase inhibitor, recently approved for the treatment of moderate to severe ulcerative colitis (UC) refractory to corticosteroid. However, currently, there is inadequate evidence for efficacy of Tofacitinib in UC patients. Therefore, our objective was to evaluate the efficacy and safety of Tofacitinib for inducing and maintaining remission in UC patients. MethodsIn a single-centre retrospective setting, 71 consecutive patients with UC who had failed to respond to corticosteroid or biologics were included. All patients had received 10mg Tofacitinib orally twice daily for at least 8 weeks as remission induction therapy and then, the responders received 5mg twice daily as maintenance therapy for up to 26 weeks. The clinical response and adverse events were evaluated at weeks 8 (induction) and 26 (maintenance). UC activity was assessed by the partial Mayo score. Clinical remission was defined as p-Mayo score ≤1 and the bleeding subscore = 0. Clinical response was defined as p-Mayo score ≤4 and a decrease of ≥3 points relative to baseline. Furthermore, the cumulative remission rates up to 26 weeks were determined by the Kaplan–Meier survival analysis. ResultsAt week 8, 24 of 71 patients (33.8%) achieved clinical remission and 20 (28.2%) achieved response level. The mean p-Mayo score fell from 5.8 ± 1.1 at entry to 3.5 ± 2.3 at week 2 (p < 0.01) and 2.3 ± 1.9 at week 8 (P<0.01). The average total cholesterol increased from 180.8 ± 36.0 mg/dl at entry to 206.8±39.3 mg/dl (p < 0.01). In anti-tumour necrosis factor (TNF)-α or vedolizumab (VDZ) naïve subgroup (n = 14), 8 patients (57.1%) achieved response level, while in biologic failure subgroup (n = 57), 36 patients (63.2%) achieved response level. In single biologic failure subgroup (n = 27), 19 patients (70.4%), in double biologics failure subgroup, 14 of 24 patients (58.3%), and in 3 biologics failure subgroup, 3 of 6 patients (50.0%) achieved response level, showing a decrease in the efficacy of Tofacitinib in patients who had failed more than one biologic. Furthermore, of the 25 patients followed for 26 weeks, 23 (92.0%) sustained remission at week 16 and 19 (76.0%) at week 26. Herpes virus infection occurred in 4 patients. The increase in total cholesterol was observed in 68.8% of the patients. ConclusionOur retrospective efficacy assessment indicated that Tofacitinib was effective and safe for inducing and maintaining remission in corticosteroid refractory UC patients, regardless of biologic naïve or failure background. The efficacy of 10mg twice daily was rapid and observed within 2 weeks of starting the treatment.

    更新日期:2020-01-17
  • P459 The impact of latent cytomegalovirus infection on the disease behaviour in patients with ulcerative colitis
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Långvall P, Shi C, Karling P.

    BackgroundCytomegalovirus (CMV) infection has been associated with steroid-refractory disease and risk for colectomy in patients with Ulcerative Colitis (UC). We aimed to study if patients with latent CMV infection more often needed systemic steroids, immunomodulators, biologics and surgery than patients negative for CMV infection. MethodsFrom the national IBD register (SWIBREG) all patients with UC (n = 404) treated at Umeå University Hospital in Sweden, and who were tested for CMV infection were included. A latent CMV infection was defined if a patient had at least one positive serology and/or a positive PCR for CMV. A retrospectively medical chart review between the years 2006 and 2019 was performed to check for medical therapy and surgery due to UC. ResultsOne hundred and thirty-one patients (32%) had at least on one occasion been tested for CMV infection and of these patients, 88 (67%) had evidence of a latent CMV infection. There were no differences in the use of systemic steroids, in the use of immunomodulators/biologics or in colectomy rate between patients with latent CMV infection and patients with no infection (table). There were no differences between patients with latent CMV infection vs. no infection in median faecal calprotectin (FC) levels the first five years after diagnosis (302 vs. 457 µg/g; p = 0.301) or at the last recorded FC test (62 vs. 82 µg/g; p = 0.317).Latent CMV infection (n = 88)No CMV infection (n = 43)p-valueMean age years (SD)42.3 (9.2)40.4 (7.8)0.246Female gender43% (n = 38)49% (n = 21)0.541Montreal classificationA116% (n = 14)19% (n = 8)0.913A279% (n = 69)76% (n = 32A35% (n = 4)5% (n = 2)E113% (n = 11)7% (n = 3)0.378E219% (n = 17)23% (n = 10)E368% (n = 60)70% (n = 30)Medical treatment (ever)Five-ASA95% (n = 84)95% (n = 41)0.978Thiopurines56% (n = 49)60% (n = 26)0.603Anti-TNF26% (n = 23)26% (n = 11)0.946Vedoluzimab3% (n = 3)2% (n = 1)>0.999Median numbers of courses with systemic steroids (25th-75th percentile)1.5 (0–4.0)2.0 (0–3.5)0.950Colectomy12% (n = 11)9% (n = 4)0.772 ConclusionPatients with latent CMV infection do not differ from CMV negative patients in the use of medical therapy for UC nor in colectomy rate.

    更新日期:2020-01-17
  • OP01 Higher vs. standard adalimumab maintenance regimens in patients with moderately to severely active ulcerative colitis: Results from the SERENE-UC maintenance study
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Colombel J, Panés J, D’Haens G, et al.

    BackgroundAdalimumab (ADA) is efficacious and well tolerated in adult patients with ulcerative colitis (UC).1,2 SERENE-UC (NCT02065622) is a study evaluating higher ADA dosing regimens from which induction study results have previously been reported3; here, we report data from the maintenance study. MethodsThis Phase 3, double-blind, randomised, multicentre study evaluated higher vs. standard ADA dosing regimens for induction and maintenance therapy in adult patients with moderately to severely active UC. Following completion of the induction study at Week 8, all patients were re-randomised 2:2:1 to ADA 40 mg every week (40 EW), ADA 40 mg every other week (40 EOW), or exploratory ADA 40 mg with therapeutic drug monitoring (TDM) regimens, stratified by induction treatment regimen, clinical response status at Week 8, and clinical remission (CRem) status at Week 8 among Week 8 responders. Efficacy endpoints were evaluated in Week 8 responders (ITT-RP) unless indicated differently. The primary efficacy endpoint was proportion of patients achieving CRem (full Mayo Score ≤2 with no subscore >1) at Week 52. The endoscopic component of the Mayo Score was scored via central reading. Non-responder imputation was used for missing values. Comparisons between 40 EW and 40 EOW dosing regimens used the Cochran–Mantel–Haenszel test adjusted for stratification. Safety assessment included a collection of adverse events (AEs), vital signs, and laboratory data. ResultsOf 852 patients in the Global (ex-Japan) induction study, 757 were re-randomised at Week 8 and 371 were included in the ITT-RP. In the ITT-RP, induction baseline demographics and disease characteristics were generally balanced across the 3 treatment arms; range across arms for mean UC disease duration was 6.2–7.8 years, 6.8–11.7% had prior infliximab use, and 62.5–63.5% were receiving corticosteroids. The overall mean ADA exposure was 252.2 days. The table displays results for efficacy endpoints. The observed safety profile was similar between maintenance treatment arms, including AEs of special interest (generally <1% across arms). ConclusionIn the Global (ex-Japan) study of SERENE-UC, CRem at Week 52 was numerically higher among Week 8 responders in patients receiving ADA 40 EW compared with 40 EOW maintenance regimens (∆ = 10.5%), but not statistically significant. Higher maintenance treatment with 40 EW was generally safe and well tolerated with a similar safety profile to 40 EOW. No new long-term safety concerns were observed. References Reinisch W, et al. Gut, 2011;60:780–7. Sandborn WJ, et al. Gastroenterology, 2012;142:257–65. Panés J, et al. UEG Journal, 2019;7(Suppl. 8):OP216.

    更新日期:2020-01-17
  • DOP61 Tofacitinib, an oral, small-molecule Janus kinase inhibitor, in the treatment of ulcerative colitis: Analysis of an open-label, long-term extension study with up to 5.9 years of treatment
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Lichtenstein G, Loftus E, Jr, Wei S, et al.

    BackgroundTofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Efficacy and safety of tofacitinib were demonstrated in patients with moderate to severe UC in 3 Phase 3 studies.1 Here, we present data from an ongoing, open-label, long-term extension (OLE) study.2 MethodsWe present updated safety and efficacy data from the OLE study (OCTAVE Open, NCT01470612; as of May 2019, database not locked). Eligible patients included non-responders (Week 8 data) in OCTAVE Induction 1 and 2 (NCT01465763; NCT01458951) and completers (Week 52 data) or treatment failures (early-termination data) in OCTAVE Sustain (NCT01458574). Patients in remission (total Mayo score ≤2, no individual subscore >1, rectal bleeding [RB] subscore 0) at Week 52 of OCTAVE Sustain (central read) received tofacitinib 5 mg twice daily (BID); all others received 10 mg BID. Induction non-responders without clinical response (≥3-point and ≥30% decrease from induction study baseline total Mayo score, plus ≥1-point RB subscore decrease or absolute RB subscore ≤1) at Month 2 of the OLE study were withdrawn. Incidence rates (IRs) for adverse events (AEs) of special interest were calculated (no. of unique patients with events per 100 patient-years). Efficacy endpoints were derived from Mayo score (local read) with non-responder and last observation carried forward imputation (NRI-LOCF) [a]. ResultsOf 944 patients who received ≥1 dose of tofacitinib, 769 (81.5%) received 10 mg BID (median duration [range]: 5 mg BID 1170 [36–2066]; 10 mg BID 668 [1–2159] days). In total, 338 (35.8%) and 93 (9.9%) patients discontinued due to insufficient clinical response and AEs (excl. worsening UC), respectively. IRs (95% confidence interval) in the Tofacitinib. All group were: deaths 0.18 (0.05, 0.47); serious infections 1.57 (1.08, 2.19); herpes zoster (non-serious and serious) 3.27 (2.54, 4.14); major adverse cardiovascular events 0.14 (0.03, 0.40); malignancies excl. non-melanoma skin cancer (NMSC) 0.92 (0.56, 1.42); NMSC 0.74 (0.43, 1.21); deep vein thrombosis 0.05 (0.00, 0.25); pulmonary embolism 0.18 (0.05, 0.47) (Table). At Month 36 (NRI-LOCF), 58.9% (n = 103) and 33.5% (n = 257) were in remission, 64.6% (n = 113) and 37.0% (n = 284) had mucosal healing (Mayo endoscopic subscore of 0 or 1) [b] and 66.9% (n = 117) and 40.2% (n = 309) showed clinical response, in the 5 and 10 mg BID groups, respectively. ConclusionIncidence of AEs remained generally consistent in patients with moderate to severe UC in the OLE study compared with a previous analysis.2 Data continue to support long-term efficacy with tofacitinib up to 36 months beyond Week 52 of OCTAVE Sustain. References Sandborn WJ et al. N Engl J Med 2017;376:1723–36 Lichtenstein GR et al. United Eur Gastroenterol J 2019;7:Abstract OP213

    更新日期:2020-01-17
  • P156 Interobserver variation of visual assessment vs. measuring ulcer size in Crohn’s disease using the RAPID9 Software in PillCam COLON2
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Quah S, Gorelik A, Tsoi E, et al.

    BackgroundUlcer size is important when assessing mucosal healing in Crohn’s disease (CD) and commonly assessed with visual estimation. There is a new built-in measurement tool in the RAPID9 reader software used in colon capsule endoscopy (CCE). We aimed to assess the agreement between visually estimating ulcer size vs. using the estimation tool and the interobserver agreement for both methods independently using PillCam Colon studies in patients with Crohn’s disease. Methods7 experts of PillCam readers were recruited to assess CCE in this study. 7 CCE recordings were thumbnailed for the presence of ulcers. A total of 43 ulcers were consecutively selected for this study. The readers were provided with an instruction manual which specified that they were to first visually estimate the ulcer and then subsequently measure the ulcer with the size estimation tool in RAPID9 software. Two measurements were taken, A – longest distance of the ulcer end to end, and B – longest distance that is perpendicular to A. Results were analysed using Kendall’s Coefficient of Concordance (Kendall’s W). ResultsWhen comparing visual assessment of ulcer size vs. using the estimation tool, both measurements A and B demonstrated statistically significant agreement (p of A = 0.000, p of B = 0.000; W of A=0.90, W of B=0.82). For measurement A, our results demonstrated higher interobserver agreement when assessing ulcer size using the estimation tool (W=0.84) as compared with visually assessing ulcer size (W=0.80). This contrasts with measurement B where there was higher interobserver agreement when visually assessing ulcer size (W=0.75) as compared with using the measurement tool (W=0.73). Nevertheless, there was no statistically significant variability amongst measurement A nor B (p = 0.000) in visual assessment and measurement tool. ConclusionThe conventional visual estimation of ulcer size in CD using CCE was just as accurate as the measurement tool. Furthermore, consistency between readers was demonstrated with the high level of interobserver agreement for the measurement tool and visual estimation. This novel finding is reassuring given the decade of capsule studies done with older software, where a measurement tool was not available. Further study should be conducted to assess and consolidate the validity of the estimation tool in assessing ulceration and mucosal healing in CD with a larger number and variety of lesions studied.

    更新日期:2020-01-17
  • P763 Epstein–Barr virus serological status in paediatric patients with inflammatory bowel disease
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Feo-Ortega S, Pujol Muncunill G, Minguez-Rodríguez B, et al.

    BackgroundThe impact of Epstein–Barr virus (EBV) infection on the clinical outcomes of children and adolescents with inflammatory bowel disease (IBD) is not well known. The aim of the study is to evaluate the seroprevalence, seroconversion rate and complications associated with EBV infection in a cohort of paediatric IBD (PIBD) patients at a tertiary care hospital. MethodsA descriptive study was performed collecting demographic, clinical and treatment data from medical records as well as EBV serological status of paediatric IBD patients from 2012 to 2018. In seronegative patients, seroconversion rate was evaluated. Complications associated with primary EBV infection were described. Since September 2016, EBV serology was included into the initial work-up for PIBD patients. For those patients who did not have EBV study at IBD onset, it was performed during follow-up. ResultsA total of 307 patients with PIBD were diagnosed between 2012 and 2018. EBV status was available for 131 patients (43%). Of those, 57% had Crohn’s Disease, 41% Ulcerative Colitis, and 2% IBD unclassified (66% males; median age at IBD diagnosis: 13.2 years (IQR: 0.8–17.8)). In 102 patients serological EBV status was determined at IBD onset; while in 17 patients it was performed during the follow-up. Overall, EBV seroprevalence was 67%, and no differences were observed regarding age (over or under 10 years-old). EBV seroprevalence was higher in females than in males (80% vs. 60.5%, p = 0.02). Regarding IBD treatment, 84% had received immunosuppressive treatment [thiopurines (32%), anti-TNF (9%) and combined treatment (59%)], without differences in the seroprevalence rate according to the treatment modality. Forty-three patients were seronegative, and 12 of them had a second determination during follow-up. Overall, 5 patients showed seroconversion (42%) after a mean follow-up of 24 months (IQR: 22–26). All these patients had received treatment with thiopurines: 2 patients presented symptomatic mononucleosis with neutropenia, requiring hospital admission and withdrawal of immunosuppressive treatment and 3 patients had asymptomatic primary infection. ConclusionEBV seroprevalence in our paediatric IBD cohort is similar as previously described in the literature. EBV status study in patients with IBD, especially prior to initiation of thiopurines, may be useful to plan subsequent follow-up since a non-negligible percentage of them could present with complicactions of primary EBV infection under immunosuppressive treatment.

    更新日期:2020-01-17
  • P663 Efficacy of tofacitinib in patients with ulcerative colitis after previous ineffective biological therapies
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Rutka M, Farkas K, Pigniczki D, et al.

    BackgroundTofacitinib (TFC) is an oral, small-molecule Janus kinase inhibitor, which was recently approved for moderate to severe ulcerative colitis (UC). The aim of the current real-life study was to determine efficacy of TFC induction therapy regarding the clinical response and remission in patients with active UC. We evaluated short-term efficacy data in a Hungarian cohort with prior exposure to other biological agents such as anti-TNF drugs and vedolizumab. MethodsIn this single-centre retrospective study, patients with TFC introduction were included. Since January 2019, a total of 16 patients received an oral TFC induction therapy in a dose of 10 mg twice daily for 8 weeks. Endoscopic activity was evaluated by endoscopic Mayo (eMayo) score before the introduction of TFC and in case of an inadequate therapeutic response to the 5-mg-therapy to confirm therapeutic decision-making. Based on the evaluation of clinical symptoms and laboratory parameters, we either kept the dosage or reduced the dose to 5 mg according to local regulations. We also collected data from the 16. and 24. weeks of the therapy. Primary endpoints were a clinical response (as a reduction in partial Mayo Score [pMayo] by minimum 3 points) or remission (as a Mayo score of the maximum of 2 points and without blood in stool) at week 8. ResultsSixteen patients had received the induction therapy (mean age: 36 years, 7 males and 9 females) in our centre. After 8 weeks, 12 (75%) patients responded to the TFC induction therapy and 6 (37.5%) of them were in remission. Four patients were primary non-responders (25%). Corticosteroid therapy (18 ± 7 mg) was required during the induction in 4 responder cases, which could be stepped down by week 8. As a continuous maintenance therapy, 4 patients have already reached the 16th week and 8 have completed the 24th week. By the end of the follow-up, 12 patients responded and 10 was in remission. During the observation period, 3 patients had to remain on 10 mg TFC dose, 6 patients required dose escalation from 5 mg to 10 mg and 5 mg was sufficient in case of only 3 patients after the introduction. Endoscopic activity showed a moderate decrease from 2.5 ± 0.5 eMayo score to 2 ± 1 (n = 7) until week 16. In respect the responder patients, CRP levels decreased from the mean of 7.23 to 5.02. No serious side-effects were observed during the follow-up. ConclusionAfter the 8-week TFC induction therapy, the response rate was high and only every fourth patients were non-responder. A low number of patients had adequate reactions to the 5 mg-therapy after the introduction, but TFC is effective with dose-escalation in respect of clinical response and remission in patients with UC, who have had an inadequate response to previous biological therapy.

    更新日期:2020-01-17
  • P257 Prognostic value of bowel ultrasonography for the management of Crohn’s disease
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Suarez Ferrer C, Poza Cordon J, Crivillen Anguita O, et al.

    BackgroundThe ‘treat to target’ strategy for managing patients with Crohn’s disease (CD) requires simple, reliable and non-invasive monitoring tools. Bowel ultrasound is an emerging technology that could be useful in this field. The aim of our study is to determine whether bowel ultrasound is a useful tool to assess activity in CD and if its results correlate with long-term evolution of the disease. MethodsPatients who had a bowel ultrasound for clinical practice between February 2013 and October 2018 in our centre were retrospectively included. Evolution of patients was assessed at follow-up based on the presence of echographic signs of activity and therapeutic changes solely based on echographic features. Results277 CD patients were included, of which 51% (142 patients) are women with a mean age at diagnosis of CD 35.3 years old (18.7 SD). The median follow-up time was 24 months (range 5–73 months). Among patients included, echographic signs of inflammatory activity were identified in 166 patients (60%). Out of these, 116 patients (70%) received treatment step-up based on the results of ultrasound. It was observed that out of the 161 patients (58%) in which of the attending physician did not modify treatment after performing ultrasound, only 43 had activity on ultrasound (26.7%). Also among patients whose treatment was scaled, 100% had echographic activity. These differences reached statistical significance (p < 0.0001). Among patients with echographic activity, disease evolution was worse than in those without activity, presenting less time to the next disease flare. Thus median disease-free survival (without flares) after performing ultrasound was 18 months when ultrasonographic activity identified (although in most patients (70%) treatment was scaled) vs. 47 months in patients without ultrasound activity, with statistically significant differences (p < 0.0001). ConclusionIntestinal ultrasound is a technique capable of detecting inflammatory activity in patients with Crohn’s disease and the presence of ultrasound activity is a risk factor for a subsequent activity flare and/or clinical relapse.

    更新日期:2020-01-17
  • P055 Effect of Mimosa caesalpiniifolia extract on DSS-induced colitis in Wistar rats
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Garnevi Fávero A, Cordeiro T, Silva K, et al.

    BackgroundIinflammatory bowel disease (IBD) is a chronic disease characterised by dysregulation of the immune function response and imbalanced release of cytokines and unresolved inflammatory progress associated with the intestinal mucosa. In this way, new drugs are constantly tested as a novel treatment option. Mimosa caesalpiniifolia (MC) has been described as a potent analgesic, anti-inflammatory, anti-haemorrhagic, astringent, anthelmintic and diuretic. This study aimed to evaluate the effect of MC extract on dextran sulphate sodium (DSS)-induced colitis in Wistar rats. MethodsForty male Wistar rats were randomised into five groups: Sham; 5% DSS-induced colitis; control MC extract (125 mg/kg/day); 5% DSS-induced colitis treated with MC (125 mg/kg/day); 5% DSS-induced colitis treated with MC + 5-ASA (125 mg/kg/day for both). Colitis was induced by administration of 5% DSS (MP Biomedicals), diluted in drinking water and offered ad libitum for 5 days. MC plant extract was diluted in water and administered by oral gavage per 6 days. The leaf extracts were prepared in 70 gl ethanol and dried in a Buchi B19 Mini-spray dryer using 20% aerosol. The selection of the operating conditions used was followed by the Laboratory of Medicinal and Phytotherapeutic Plants of Unifal-MG. After the induction of colitis, body weight, general health status and faecal characteristics will be evaluated daily. All rats were euthanised on the ninth day of the experiment. The entire colon was dissected and fixed in 10% neutral-buffered formalin at room temperature and embedded in paraffin to provide sections for histological evaluation (Ethics Committee on the Use of Animals number 4362180119). The severity of colitis was evaluated in sections stained with Hematoxylin and Eosin. Parameters such as inflammation extent, regeneration and crypt damage were graded according to Dieleman et al. Statistical analysis was performed by one-way analysis of variance (ANOVA), followed by Tukey post hoc test using Graph Pad Prism (version 6.0). ResultsMC extract treatment reduced significantly the severity of DSS-induced colitis evidenced by a decreased in clinical symptoms (p < 0.0001). The rats treated with MC extract showed a decreased in diarrhoea episodes and rectal bleeding. We observed histopathological changes of colon tissue between the DSS-treatment and control groups, however, without statistical significance. The MC extract treatment reduced the damage to the colonic tissue evidenced by a decreased of inflammatory cells, ulcerations, and goblet cell preservation. ConclusionMC extract reduces the clinical signs and suggests a potential anti-inflammatory effect on DSS-induced colitis.

    更新日期:2020-01-17
  • P358 Predictors of response to faecal microbiota transplantation in patients with active ulcerative colitis
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Singh A, Sood A, Midha V, et al.

    BackgroundFaecal microbiota transplantation (FMT) has been shown to be effective for induction of remission in nearly 50% patients with active UC. At present, factors impacting the response to FMT in UC remain unclear. MethodsPatients with active UC treated with FMT via colonoscopy at weeks 0, 2, 6, 10, 14, 18, and 22 between September 2015 and March 2019 were analysed. Response to FMT was defined as achievement of clinical remission (Mayo score ≤2, with each sub-score ≤ 1 and endoscopic subscore of 0) at week 22. Patient and disease characteristics and FMT-related factors, considered to affect response to FMT were evaluated in a multivariable logistic regression analysis to determine the predictors of response to FMT. A statistical model was subsequently developed for predicting the success of FMT. ResultsOut of 140 patients with active UC and treated with FMT [mean age 34.29 ± 11.51 years, 65.71% males (n = 92), mean total Mayo score 7.8 ± 2.26], 57 (40.71%) achieved clinical remission. Of the various factors analysed, disease extent E2 (OR 2.34, 95% CI 1.17–4.68, p = 0.016), endoscopic Mayo score 1 (OR 15.375, 95% CI 1.89–125.11, p = 0.011) or 2 (OR 2.12, 95% CI 1.06–4.25, p = 0.035) and number of FMT sessions ≥ 4 (OR 16.74, 95% CI 4.85–57.85, p < 0.001) were found to be associated with response to FMT. An estimated response score was developed and score ≥4 predicted response to FMT with an accuracy of 74.3% [sensitivity 64.79% (95% CI 52.54% to 75.76%); specificity 84.06% (95% CI 73.26% to 91.76%, AUROC 0.834)].Table 1.Baseline characteristics of patients (n = 140)Mean age (years) (mean ± SD)34.29 ± 11.51Males (n) (%)92 (65.71)Disease duration (years) (mean ± SD)4.71 ± 4.57Disease extent (n) (%) E126 (18.57) E259 (42.14) E355 (39.28)Disease Severity (n) (%) Moderate (Mayo score 6–9) Severe (Mayo score ≥10)108 (77.14) 32 (22.86)Mayo score (mean ± SD)7.8 ± 2.26Endoscopic Mayo score (mean ± SD)2.47 ± 0.62Number of FMT sessions (n) (mean ± SD)5.37 ± 2.68Faecal slurry retention time (h) (mean ± SD)3.11 ± 1.63Concomitant medications (n) (%) 5-ASA140 (100) Azathioprine69 (49.28) Corticosteroids114 (81.42) BiologicsNil Previous exposure to biologics (n) (%)29 (20.71) ConclusionDisease Extent E2, endoscopic mayo score 1 or 2, and number of FMT sessions ≥4 predict response to FMT in active UC. The prediction model has good discriminative power at identifying individuals likely to respond to FMT.

    更新日期:2020-01-17
  • P561 The management of Crohn’s disease (CD) patients post ileocaecal resection: a multicentre, regional audit in Northern England
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    BATCHELOR S, , Speight A, et al.

    Background70% of patients with Crohn’s disease (CD) require intestinal resection.1 Post-operative recurrence (POR) is common with 70% of patients requiring further surgery in the pre-biologic era.2 ECCO guidelines suggest identifying patients at risk of recurrence (disease phenotype, smoking, prior resection), the use of imidazole antibiotics following surgery and assessment for recurrence within 12 months. The ECCO guidelines recommend ileocolonoscopy, although alternative modalities can be used. The Rutgeerts score predicts POR and is recommended to establish the need for preventative treatment.3 The aim of this study was to undertake a region-wide audit of practice with regards to post-operative CD in the Northern region. MethodsA regional, multicentre, retrospective audit was conducted by GRANT, a network of gastroenterology trainees in Northern England. Data collection was performed for CD patients who had an ileocaecal resection between 1/9/16 and 1/9/17. Patients with an end-ileostomy were excluded. Patients were identified using clinical coding and data collection sheets were completed. ResultsSeven of 9 Hospital Trusts returned data. The number of eligible patients was 38 with a mean age of 41 years. Seventy-six per cent (29/38) patients had at least one risk factor rendering them ‘high-risk’ for POR (Figure 1). Only 13% (5/38) of patients received imidazole antibiotics postoperatively and only 29% (11/38) had an ileocolonoscopy within 12 months. However, 32% (12/38) had an alternative assessment of POR, with calprotectin being the most popular. An escalation in treatment following assessment was required in 25% (9/38) of patients. Postoperatively, 40% (15/38) of patients had no maintenance therapy before POR assessment; 26% (10/38) continued on the same therapy as preoperatively and34% (13/38) had augmented pre-operative therapy. ConclusionThe majority of patients in Northern England who have an ileocaecal resection for CD are high risk for recurrence and many patients are not being assessed. Endoscopic POR predates clinical POR [4] and, without monitoring, the opportunity to augment therapy and prevent clinical recurrence can be missed. In Northern England, less invasive disease monitoring is being used to assess for POR and this audit would suggest that these have a comparable rate of identifying a need to escalate maintenance therapy. A postoperative CD management bundle is being developed and will be implemented to assess whether this drives improvement.

    更新日期:2020-01-17
  • OP02 Impact of therapeutic strategies on intestinal resection rate in paediatric inflammatory bowel diseases: A population-based cohort study over a 24-year period (1988–2011)
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Ley D, , Leroyer A, et al.

    BackgroundFew data are available at the population level on the impact of the changes in therapeutic strategies over the last decades on inflammatory bowel diseases (IBD) long-term outcomes. We have evaluated the impact of immunosuppressants (IS) and anti-TNF introduction on intestinal resection rate, hospitalisation, and Crohn’s disease (CD) behaviour progression in a large population-based paediatric-onset IBD cohort. MethodsPaediatric-onset IBD (<17 years) were issued from a prospective population-based study in France between 1988 and 2011 and were retrospectively followed until 2013. Risks for intestinal resection, hospitalisation and complicated CD behaviour (stricturing or penetrating) were compared between three diagnostic periods: 1988–1993 (P1), 1994–2000 (P2) and 2001–2011 (P3) using Kaplan–Meier survival analyses. ResultsOne thousand and sixty-one patients diagnosed with CD (n = 800) or ulcerative colitis (UC, n = 261) were followed up during a median of 8.9 years (IQR: 5.0–14.7). Median age at diagnosis was 14.3 years (IQR: 11.8–16.0) and half of patients were female (n = 530, 50%). Over time, in CD, the IS and anti-TNF exposure rate increased from, respectively, 32% (P1) to 75% (P3) and from 0% (P1) to 51% (P3) at 5 years. In UC, IS and anti-TNF exposure increased from, respectively, 9% (P1) to 65% (P3) and from 0% (P1) to 40% (P3) at 5 years. In parallel, risk for intestinal resection at 5 years significantly declined in CD (P1: 35%, P2: 30%, P3: 20%, p < 0.05). No significant change in 5-year colectomy risk in UC was observed (P1: 14%, P2: 19%, P3: 9%, p = 0.08). Exposure to corticosteroid at 5 years of diagnosis did not change over time (P1: 10%, P2: 10%, P3: 8%, p = 0.54). Risk for IBD-flare-related hospitalisation at 5 years was similar over time in CD (P1: 43%, P2: 45%, P3: 43%, p = 0.60) and UC (P1: 31%, P2: 46%, P3: 52%, p = 0.10). Progression to a complicated behaviour in CD at 5 years did not change over time (P1: 31%, P2: 33%, P3: 25%, p = 0.20). ConclusionIn parallel with the increased use of IS and anti-TNF agents, risk for intestinal resection within 5 years after diagnosis decreased in paediatric CD, whereas risks for flare-related hospitalisation and behaviour progression remained unchanged over a 24-year period.

    更新日期:2020-01-17
  • P764 Phenotypic analysis of patients with inflammatory bowel disease: 23 year data of a centre in a South American country
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Páez Cancelado C, García Duperly R, Park J, et al.

    BackgroundInflammatory Bowel Disease (IBD) includes Ulcerative Colitis (UC) and Crohn Disease (CD). In the last decade, there have been introduced therapeutic changes that have revolutionised the pharmacologic and surgical management of patients with IBD. The incidence of UC and CD has been increasing in Latin America but the exact prevalence is unknown. Our objective is to describe the demographic characteristics, clinical and therapeutic aspects of the IBD in patients that have presented in the University Hospital Fundación Santa Fe de Bogotá (UH-FSFB), Colombia. MethodsRetrospective Descriptive Cohort Study. Clinical histories, pathology reports, and endoscopic results from data base HI-ISIS of the UH-FSFB and medical data between January 1996 and February 2019 were recollected, stored in Excel and analysed using IBM SPSS Statistics Visor. Patients with diagnosis of IBD were included. Patients with incomplete clinical histories were excluded. ResultsFrom 398 patients included in this study, 72.1% had UC, 25.6% CD and 2.3% Indeterminate Colitis. The average age of diagnosis was 43.54 years (range: 12–91). In both patients with UC and CD there were smaller proportions of men than women (0.9:1 for UC and 0.7:1 for CD).Of the patients with UC, 46.3% had been hospitalised. 37.2% presented with proctitis, 23.8% left colitis and 39% with pancolitis. 13.5% had an asymptomatic clinical disease, 22.4% mild, 15.3% moderate, and 48.8% severe. 12.9% received biological therapy (BT). 24.3% of patients received a second line BT. Fifteen per cent required surgical interventions (SI), of which there were no mortalities. 27% who were receiving BT required SI.Of the patients with CD, 82.4% required hospitalisation. 43.1% had an ileal, 9.8% colonic, 39.2% ileal- colonic, 0% isolated upper digestive and 21.6% perianal compromise. 34.3% had non-stenosing behaviour, 49% stenosing and 16.7% penetrating. 44.1% of patients with CD received BT of which 40% required a second line BT. 55.9% required SI, of which 1 mortality was reported. 71.1% who were receiving BT required a SI. ConclusionOur study contributes to the epidemiology and integral management required by patients with IBD in our environment. More studies are recommended that replicate our methodology in the population with IBD in both Colombia and Latin America.

    更新日期:2020-01-17
  • P157 Patient-reported disease activity in a large sample of ulcerative colitis patients using social media-delivered questionnaires
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Abreu M, Cataldi F, Van Horn K, et al.

    BackgroundMedical therapy for inflammatory bowel disease (IBD) should have dual goals of improving symptoms and mucosal healing. Patient-reported outcomes (PROs) used for approval of ulcerative colitis (UC) treatments include number of bowel movements and bloody stools.[1] Recent research highlights the discordance between PROs and mucosal healing.[2] The aim of this analysis is to understand patient perspectives on UC symptoms and disease burden based on a cross-sectional survey of UC patients. We hypothesised that UC patients experience disease activity despite treatment and that current PROs fail to capture the full impact of disease activity on patients’ lives. MethodsThe IBD In America survey recruited patients via InflammatoryBowelDisease.net and associated social platforms in 2019. Patients self-reported an IBD diagnosis, were 18+, lived in U.S., and participated without monetary incentive. Survey questions addressed diagnosis, symptoms, QoL, treatment, demographics, etc. Survey terms were based on how patients discuss UC in the IBD online community. Remission was defined as ‘significant reduction of symptoms without an actual cure.’ Flare was defined as ‘temporary intensification of symptoms.’ Patients were categorised by disease activity based on number of flares and remission status during the past year. ResultsOf 487 patients diagnosed with UC, mean age was 45.6 (SD 16.0); 85% were female; 89% moderate to severe; 78% diagnosed in past 5 years; and 51% taking 5ASAs, 37% biologics/JAKs, and 23% immunomodulators. Despite treatment, 46% experienced 15+ symptom days in the past month. Fatigue/low energy was most frequent complaint (86%) followed by urgency to move bowels (80%), abdominal pain/cramps (76%), joint pain/inflammation (67%), and bloating (66%). Daily pain was experienced by 32%; even patients in remission with no flares experienced pain at least once a month (55%). Difficulty completing daily tasks was reported by 37%, and 27% felt their UC was not controlled despite efforts to manage it. Only 7% reported being in remission with no flares (past year) and no symptoms (past month). ConclusionMost UC patients experience frequent symptoms and flares while on treatment. The most common and bothersome symptoms are not taken into account in PROs nor addressed with current treatment. A more holistic approach to patient disease is needed. Reference Partial Mayo Scoring Index [2] Ma, C., Sandborn, W.J., D’Haens, G.R., Zou, G., Stitt, L.W., Singh, S., Ananthakrishnan, A.N., Dulai, P.S., Khanna, R., Jairath, V.l., & Feagan, B.G. (in press). Discordance between patient-reported outcomes and mucosal inflammation in patients with mild to moderate ulcerative colitis. Clinical Gastroenterology and Hepatology. doi: 10.1016/j.cgh.2019.09.021

    更新日期:2020-01-17
  • N17 Profile of ostomy patients treated at a referral hospital for inflammatory bowel disease
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Barros J, Herrerias G, Oliveira L, et al.

    BackgroundAs part of the surgical treatment of inflammatory bowel disease (IBD), sometimes is necessary the intestinal stoma. The aim of this study is to identify the profile of ostomy patients treated at a referral public hospital in IBD in Brazil. MethodsThis is a descriptive study with a quantitative approach. The sample consisted of all patients who underwent stoma surgery at a referral public hospital in IBD in Brazil. The inclusion criteria were: to have a medical diagnosis of Crohn’s Disease (CD) or Ulcerative Colitis (UC) and to have or have had intestinal stoma. Data collection was performed through the analysis of patient records. ResultsThe number of patients attending the outpatient clinic is approximately 200 with UC and 150 with DC. The sample consisted of 33 patients, the majority of male gender (51.52%), age between 22 to 77 years (44.55 ± 15.10), literate (93.94%), self-declared white (84.85%), coming from the state of São Paulo (96.97%), smokers (6.06%), alcoholics (3.03%), married (63.64%) and the number of children ranged from 01 to 10. Regarding the characteristics related to IBD, 15 (45.45%) were diagnosed with CD, 6 (40%) were fistulising ileocolonic type and 18 (54.55%) were diagnosed with UC and most with pancolitis (88.89%). The average time of illness was 14.2 years. Among the causes of the stoma, the most frequent were perforating acute abdomen (n = 5, 15.15%), severe acute colitis (n = 4, 12.12%), obstructive acute abdomen (n = 4, 12.12%), toxic megacolon. (n = 3, 9.09%) and neoplasia (n = 2, 6.06%). Regarding the character of the surgery, 10 (30.30%) were urgency and emergency and 11 (33.33%) elective. Only 5 (15.15%) surgeries performed the previous demarcation of the stoma. Regarding the types of stoma, 4 (12.12%) had temporary colostomy and 3 (9.09%) permanent, 16 (48.48%) had temporary ileostomy and 3 (9.09%) permanent. The average time of stoma was 3.19 years. 2 (6.06%) colostomised and 9 (27.27%) ileostomised reversed the stoma. 2 (6.06%) patients refused intestinal reconstruction. ConclusionThe study results showed us that IBD with more severe extension and behaviour can result in intestinal ostomy, either temporary or permanent. The characterisation of ostomised patients is necessary for the identification of nursing needs to be highlighted, such as the previous demarcation of the stoma.

    更新日期:2020-01-17
  • P460 Evaluation of potential mechanisms underlying the safety observations of filgotinib in clinical studies in rheumatoid arthritis
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Clarke A, Di Paolo J, Downie B, et al.

    BackgroundInhibitors of the Janus kinase-signal transducers and activators of transcription (JAK-STAT) pathway have demonstrated efficacy in the treatment of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Differences in selectivity of JAK inhibitors for JAK1, JAK2, JAK3 and TYK2 may influence their respective safety profiles, and the mechanisms responsible are not currently known. Filgotinib (FIL), a JAK1 inhibitor, did not negatively impact haemoglobin, LDL:HDL ratios or natural killer (NK) cell counts in clinical trials. Here, we compare the in vitro mechanistic profiles of four JAK inhibitors at clinically relevant doses. MethodsJAK inhibitors (FIL, FIL metabolite [GS-829845], baricitinib [BARI], tofacitinib [TOFA], and upadacitinib [UPA]) were evaluated in vitro in human-cell-based assays. Growth of erythroid progenitors from human cord blood CD34+ cells was assessed using a HemaTox™ liquid expansion assay, NK cell proliferation was induced by IL-15 and LXR agonist-induced cholesteryl ester transfer protein (CETP) expression was assessed in the hepatic cell line, HepG2. Using assay-generated IC50 values and the reported human plasma concentrations from clinical studies, we calculated the target coverage for each JAK inhibitor at clinically relevant doses. The activity of FIL in humans was based on PK/PD modelling of FIL + GS-829845. ResultsInhibition of cellular activity was calculated for each JAK inhibitor based on in vitro dose-response data, human exposure data and modelled PK/PD relationships. At clinically relevant doses, FIL resulted in lower calculated inhibition of NK cell proliferation compared with other JAK inhibitors. FIL 100 mg and 200 mg also reduced CETP expression, whereas other JAK inhibitors had no effect. There was no difference in the effect of FIL vs. other JAK inhibitors on erythroid progenitor cell differentiation or maturation. ConclusionFIL, a JAK1 inhibitor, resulted in less inhibition of NK cell proliferation compared with BARI, TOFA, and UPA. FIL also reduced LXR agonist-induced CETP expression, while the other inhibitors did not alter these levels. These results provide a potential mechanistic link between the observed reduction of CETP concentration following FIL treatment and the previously observed reduction in the LDL:HDL ratio in RA patients.

    更新日期:2020-01-17
  • OP03 Reduced need for surgery and medical therapy after early ileocaecal resection for Crohn’s disease: Long-term follow-up of the LIR!C trial
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Stevens T, , Haasnoot L, et al.

    BackgroundThe LIR!C trial showed that laparoscopic ileocaecal resection is at least as good as anti-TNF in terms of quality of life and is cost-saving. Current aims were to compare the long-term outcome of both interventions and to identify factors associated with the failure of the initial therapeutic strategy. MethodsLong-term data were retrospectively collected for patients who participated in the LIR!C trial, a multicentre, randomised controlled trial that compared a laparoscopic ileocaecal resection with infliximab for adult patients with non-stricturing and immunomodulator refractory ileocaecal Crohn’s disease. Outcomes of interest needed for (re-)surgery or anti-TNF, duration of treatment effect as well as the identification of factors associated with sustained treatment effect. The treatment effect was defined as the time without the need for additional Crohn-related treatment. Potential factors were defined a priori and analysed by multivariable Cox regression analysis. ResultsMedian follow-up time was 63.5 [IQR 39 – 94.5] months. In the resection group, 18 (26.1%) patients started anti-TNF treatment while none of the patients required a second resection (Figure 1). Twenty-nine (42%) patients did not require additional Crohn-related treatment. In contrast, in the infliximab group, 31 (47.7%) patients underwent a Crohn-related resection. Duration of treatment effect was similar with a median (95% CI) time without additional treatment of 33 (15.1–50.9) and 34 (0–69.3) months in the resection and infliximab group respectively (log-rank p = 0.521). In both groups, prophylactic immunomodulators decreased the risk of additional treatment (HR 0.34 95% CI (0.16–0.69) and HR 0.49 95% CI (0.26–0.93), respectively).Figure 1.Need for anti-TNF and (re-)surgery ConclusionThis long-term follow-up study of the LIR!C trial showed that after a median follow-up of 5 years the majority of patients who underwent resection were free of anti-TNF treatment, none required a second resection and almost half were free of any additional medical treatment for disease flares. Conversely, almost half of the patients in the infliximab group moved on to a Crohn-related resection. These data support early ileocaecal resection in Crohn’s disease patients not responding to conventional treatment.

    更新日期:2020-01-17
  • P562 5-ASA in ulcerative colitis: Are they really needed in the biological therapy era?
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Arieira C, Dias de Castro F, Cúrdia Gonçalves T, et al.

    BackgroundBiologic therapy has demonstrated efficacy for induction and maintenance of remission in ulcerative colitis (UC). However, it remains unclear whether oral aminosalicylates (5-ASA) should be continued or stopped after treatment escalation to biologics. The aim of the study was to evaluate differences in inflammatory biomarkers or the occurrence of complications in UC patients being treated with a combination of 5-ASA and biologics vs. biologics alone. MethodsRetrospective study, including patients with UC and on biologic therapy with a minimum follow-up of 6 months. Collected inflammatory biomarkers were faecal calprotectin, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). The occurrence of complications was defined as the need of hospitalisation, need of corticosteroids or other top-up therapy, surgery and the occurrence of dysplasia or colorectal cancer. ResultsWe included 65 patients with UC, 56.9% female with a mean age of 32.8 (±12.8) years. The median follow-up was 30 (6–132) months. Regarding extension, 61.5% were E3, 35.4% E2 and 3.1% E1. While 44 patients (67.7%) were on 5-ASA and biologics (infliximab = 32, adalimumab = 6, vedolizumab = 6), 21 (32.3%) were on biologics alone (infliximab = 13, adalimumab = 3, vedolizumab = 5). The median duration of biologic therapy was 30 (6–126) months. Regarding baseline characteristics, including age, gender, duration of the disease or biologic therapy and age at UC diagnosis, there were no differences between groups. No differences regarding inflammatory biomarkers were observed – fecal calprotectin (p = 0.39), CRP (p = 0.9) and ESR (p = 0.61). No differences were found regarding complications, namely the need of hospitalisation (p = 0.06) or need of corticosteroids (p = 0.89). Only one patient developed dysplasia (under infliximab and 5-ASA). Any of the included patients needed surgery or developed colorectal cancer. ConclusionAbout two-thirds of the UC patients under biologics are co-treated with 5-ASA. No differences between UC patients under combination biologics+5-ASA vs. biologics alone were found regarding inflammatory biomarkers or the occurrence of complications. These results raise the question if continuing 5-ASA in UC patients under biologics is really necessary.

    更新日期:2020-01-17
  • P664 The impact of vedolizumab on extra-intestinal manifestations in inflammatory bowel disease patients: A real-life experience of a single-centre cohort
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    TRUYENS M, Geldof J, Dewitte G, et al.

    BackgroundVedolizumab (VDZ), a gut-specific anti-integrin, is approved as a treatment for moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). Extra-intestinal manifestations (EIMs) are frequently associated with inflammatory bowel disease (IBD). However, the effect of VDZ on EIMs remains unknown. The aim of the current study was to describe the prevalence of EIMs in IBD patients at VDZ initiation, the evolution during continued treatment as well as the occurrence of new EIMs. MethodsA single-centre study was performed in IBD patients who were started on VDZ between May 2010 and February 2019. Retrospectively, the physician-reported EIMs and intestinal disease activity (clinical and endoscopic) were assessed at baseline, 6 months and 1 year after the start of VDZ. ResultsThe cohort consisted of 134 patients, including 77 CD patients, 56 UC patients and 1 patient with unclassified IBD. At VDZ initiation EIMs were assessed in 127 patients and 17.3% had ≥ 1 EIM: 9 hepatic EIMs (2 patients with toxic hepatitis, 2 with autoimmune hepatitis and 5 with PSC), 7 arthropathies (6 patients with axial spondyloarthropathy and 1 with peripheral arthritis), 3 non-further specified axial or peripheral arthralgias and 3 cutaneous EIMs (urticaria, psoriasis and erythema nodosum). Clinical evolution of the EIMs is reported in Table 1, assessment of intestinal disease activity in Table 2. During follow-up, 23 new EIMs were seen, mainly arthralgia, which was often transient. VDZ was stopped in 39/130 (30%) patients due to active intestinal disease in 32 patients, patients’ choice (n = 1) or because of deep disease remission (n = 1). In five patients, VDZ was stopped because of insufficient control of EIM.Table 1.6 weeks (n = 121): 26 (21.5) ≥ 1 EIM6 months (n = 113): 26 (23%) ≥ 1 EIM1 year (n = 104): 17 (16.3%) ≥ 1 EIMn(%)StableWorseNewTotalImprovedStableWorseNewTotalStableWorseNewTotalArthropathy4 (66.7)02 (33.3)62 (25)5 (62.5)01 (12.5)88 (100)008Arthralgia3 (30)1 (10)6 (60)101 (10)5 (50)04 (40)104 (100)004Skin EIM01 (25)3 (75)41 (33.3)002 (66.7)3001 (100)1Liver EIM5 (100)005005 (83.3)1 (16.7)65 (100)005Myalgia002 (100)201 (50)01 (50)21 (50)1 (50)02Table 2.Clinical, n (%)6 months (n = 109)1 year (n = 106)No response13 (11.9)10 (9.4)Response34 (31.2)24 (22.6)Remission62 (56.9)72 (67.9)Endoscopic, n (%)Post induction (n = 81)1 year (n = 44)No response24 (29.6)12 (27.3)Response35 (43.2)7 (15.9)Remission22 (27.2)25 (56.8) ConclusionA good clinical intestinal response was observed. However, the clinical evolution of EIMs appears unaffected by the use of VDZ in our cohort. Prospective data are needed to confirm these results.

    更新日期:2020-01-17
  • P765 Fatigue as one of the most important symptoms in adult patients with inflammatory bowel disease: Croatian tertiary centre pilot study
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Ćaćić P, Tomašić V, Kralj D, et al.

    BackgroundAlthough there have been revolutionary improvements in care of IBD patients, considering the effect of lifelong disease with numerous relapses, one of our goals is to recognise burden of chronic symptoms such as fatigue which can significantly interfere with performance of everyday activities, and negatively impact on quality of life (QoL). MethodsRandomly selected IBD patients were invited to anonymously fulfil multiple mixed-methods (quantitave/qualitative) Quality of Life questionnaires (SF-36, IMPACT, SIDBQ, IBD disk) in order to evaluate prevalence of fatigue as well as the variables associated with an increased risk of fatigue (using the Fisher’s exact test). ResultsThe study population included 70 patients (50.7% male, mean age 38.1 years, 55.7% Crohn’s disease). The prevalence of fatigue was 48.6% and variables associated with an increased risk of fatigue were: anxiety/depression (p = 0.002), lower perception of general well-being (p = 0.03), sleep disturbance (p = 0.02), inadequate interpersonal interactions (p = 0.03) and unsatisfactory performance in educational and professional daily activities (p = 0.01). The presence of joint pain as a common extraintestinal manifestation of IBD was not associated with fatigue (p = 0.06). ConclusionChronic fatigue is a debilitating symptom among adult patients with IBD. Anxiety/depression, lower perception of general well-being, sleep disturbance, inadequate interpersonal interactions and unsatisfactory performance in educational and professional daily activities were associated with fatigue in this Croatian cohort of IBD patients.

    更新日期:2020-01-17
  • P359 Platelet-rich stroma injection (PRS) as a novel surgical treatment of refractory perianal fistulas in Crohn’s disease: A pilot study
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Arkenbosch J, van Ruler O, Dwarkasing R, et al.

    BackgroundPerianal fistulizing Crohn’s disease (FCD) comes with significant morbidity and severe reduced quality of life. Treatment of FCD is challenging and includes immunosuppressive drugs, antibiotics and surgery. All therapies are associated with high recurrence rates. Platelet-rich stroma (PRS) is a combination of platelet-rich plasma (PRP) and stromal vascular fraction (SVF). Autologous PRS includes stromal cells in their matrix with stimulating factors, plays an essential role in wound repair and defence mechanisms against infection and is easy to obtain and inject. Because of its operating mechanism, PRS could be of additional value in patients with refractory FCD. This study aims to assess the feasibility, safety and efficacy of local injection of PRS in patients with refractory FCD. MethodsAfter informed consent, 10 patients (age ≥16 years) with refractory FCD were included between March 2018 and July 2019. Exclusion criteria were rectovaginal fistulas, persistent proctitis and pelvic abscesses. All patients underwent surgery with harvesting of subcutaneous fat and venous blood sampling to obtain 6 ml of PRS (1 ml of SVF resp. 5 ml of PRP), excision of the external opening(s), fistula curettage, and injection of PRS in the fistula wall and closure of the internal opening. A pre- and postoperative MRI was performed. Endpoints were clinical outcome, both closure and absence of discharge at physical examination, patient-reported outcome (no effect/moderate effect/major effect), as well as radiological outcome (van Assche score). From 3 months postoperative, re-injection of PRS was considered in patients with unfavourable clinical and/or radiological outcome. ResultsAll patients (4:6 female:male; median age 33 (IQR 22.9–38.7) had infralevatoric fistulas with a median van Assche score of 17 [range 14–20] without rectal involvement and abscesses. Median follow-up was 6 months [4–12]. The median duration of FCD was 4 years (IQR 2–5). The median number of drugs given were 4 [1–7] and number of operations 3 [2–3], including stoma formation in 2 patients. Crohn’s disease activity outside the anorectum was present in all patients. 7 patients underwent 1 PRS injection and 3 patients 2 injections. There were no complications of the PRS injection. Fistula closure was present in 5 patients and open in 5 patients, of which 2 patients had no signs of discharge. One patient underwent restoration of bowel continuity. Of 7 postoperative MRIs available to date, median decrease of van Assche score was 4 (17 vs. 13)[0–15]. Patient-reported outcome was major effect in 4, moderate effect in 3, and no effect in 3 patients. ConclusionAutologous PRS appears to be feasible, safe and promising in the treatment of refractory perianal fistulizing Crohn’s disease.

    更新日期:2020-01-17
  • P158 Semi-automated detection of qualitative features of Crohn’s disease activity found on CT-enterography using machine learning
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Stidham R, Enchakalody B, Waljee A, et al.

    BackgroundImaging is essential in the assessment of Crohn’s disease (CD) severity, phenotype, and therapeutic response. However, qualitative findings can be limited by interobserver variation and ambiguous feature definitions. Our aim was to evaluate computational approaches for identifying qualitative disease features using CT-enterography (CTE). MethodsCD subjects with ileal CD and CTE imaging between 2009 and 2017 were retrospective identified at a single tertiary care centre. CTE scans were reviewed by two fellowship-trained abdominal radiologists who labelled diseased and normal bowel transitions agreeing on definitions of qualitative findings prior to labelling. Computed intestinal features were used by machine learning methods (k-nearest neighbour, support vector machines, random forest) to model regions of diseased bowel and predict qualitative findings with 5-fold cross validation. Cohen’s kappa with quadratic weighting was used to assess agreement between radiologists and model predictions. ResultsIn 206 unique patients, 548 small bowel segments underwent paired radiologist review for qualitative imaging findings. Automated localisation of diseased vs. normal bowel segments had excellent performance, with an AUC, PPV, and NPV of 0.922, 0.924, and 0.918, respectively (Figure 1). Radiologist-to-Radiologist and Radiologist-to-automated prediction agreement on qualitative findings are shown in Table 1. Agreement on the degree of mural enhancement between radiologists was very good (k = 0.75,95% CI 0.68–0.82), with nearly identical agreement (k = 0.75, 95% CI 0.72–0.79) between radiologists and automated grading models.Table 1.Agreement of qualitative imaging findings of Crohn’s disease between radiologists and automated methodsRadiologist–radiologistAutomated prediction performanceKappa (95% CI)Kappa (95% CI)PPVNPVAUCBowel Wall Thickening0.75 (0.69–0.81)0.77 (0.74–0.80)85.6%91.1%0.922Lumen Narrowing0.55 (0.49–0.61)0.65 (0.60–0.69)73.9%90.2%0.859Mural Stratification0.76 (0.71–0.81)0.51 (0.46–0.56)65.2%87.0%0.809Fat Stranding0.34 (0.27–0.41)0.26 (0.18–0.33)77.4%88.7%0.879Vascular Engorgement0.61 (0.51–0.71)0.14 (0.06–0.22)47.4%91.6%0.909Figure 1.Example figure of a section of distal ileum affected by Crohn’s disease with radiologist and predicted qualitative findings shown. Automated disease segment identification was very good with an AUC of 0.922, reflecting both disease/non-disease prediction and spatial localisation of disease. ConclusionComputer vision methods have excellent performance for automatically distinguishing diseased from normal ileum and show potential for qualitative disease assessments of Crohn’s disease on CTEs.

    更新日期:2020-01-17
  • N18 Facilitating involvement of patients from ethnic minority groups in research: experiences of offering patients a choice of interviewer
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    MUKHERJEE S, Beresford B.

    BackgroundRecruitment of inflammatory bowel disease (IBD) patients from an ethnic minority background to research is known to be very low. It has been suggested that interviewer characteristics may affect the willingness of individuals to take part in research, with some researchers advocating ethnicity and gender matching. A study on UK South Asian adults’ experiences of living with IBD provided an opportunity to explore these methodological issues further. MethodsThe study comprised qualitative interviews with adult patients with IBD identifying themselves as Indian/British Indian, Pakistani/British Pakistani, and Bangladeshi/British Bangladeshi. They were recruited from five clinics across England. Rather than presupposing what participants’ preferences might be, patients were offered a choice of interviewer in terms of the following characteristics: gender, shared experience (or not) of IBD, ethnicity and language (Bengali, Gujarati, Hindi, Mirpuri, Punjabi, Urdu). These interviewers were a particular type of ‘peer researcher’; distinctive in that they are a professional researchers and assumptions have not been made about the ‘peer’ characteristic which is most pertinent to study participants. ResultsAdopting this study design required strategic planning in terms of resources and research management. Recruitment to the study was good, with over 40% of those invited (n = 41) returning a response form indicating an interest in taking part. Some had no preference over who interviewed them (8 women, 6 men). Where a preference was expressed, gender was the most important factor. Almost all favoured a female rather than a male interviewer (12 vs. 1). The next most frequently requested option was for an interviewer with personal experience of IBD (n = 11). Very few prioritised the ethnicity of the interviewer. Of those that did, two also requested to be interviewed in a South Asian language. Involvement of ‘peer interviewers’ in the development of the interview guide led to the addition of research questions that would not otherwise have been included. In some interviews, shared experience (between interviewer and interviewee) increased the richness of data elicited which, on occasion, threatened ‘even-ess’ of emphasis across the dataset. ConclusionThe study achieved an above average recruitment rate, the sampling frame was achieved, and rich data was generated. The research team intend to adopt a similar approach in future studies where it is anticipated recruitment to the study may be challenging and the topics for discussion are sensitive.

    更新日期:2020-01-17
  • P461 Intolerance to 5-aminosalicylate is a risk of poor prognosis in ulcerative colitis patients
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Fujii T, Hibiya S, Maeyashiki C, et al.

    Background5-Aminosalicylates (5-ASA) are the key drugs in induction and maintenance therapy in ulcerative colitis (UC). Some UC patients are involved in 5-ASA intolerance after induction of oral 5-ASA compounds. There is no evidence of the prognosis including the risk of colectomy in 5-ASA intolerant UC patients. MethodsThe aim of this study is to establish the prognosis of 5-ASA intolerant UC patients in a multicenter cohort study. A retrospective review of a prospective multicenter database (2014–2018) of 1,574 UC patients was carried out and a total of 1,286 patients treated with oral 5-ASA compounds were enrolled. We compared the risk of colectomy and biologics induction between patients (i) tolerant to first 5-ASA compound (1079), (ii) intolerant to first 5-ASA compound but tolerant to other 5-ASA compound (107) and (iii) intolerant to 5-ASA compound and withdrawal of 5-ASA (100). ResultsWe identified 1,286 patients with UC, of which 40 patients (3.1%) resulted in colectomy and 247 patients (19%) treated with biologics. Colectomy rate in patients (iii) intolerant to 5-ASA and withdrawal of 5-ASA were higher than (i) tolerant to first 5-ASA and (ii) intolerant to first 5-ASA but tolerant to other 5-ASA (9.0%, 2.7%, 1.9%, respectively). (iii) Patients withdrawal of 5-ASA showed higher risk of colectomy compared with (i) tolerant to first 5-ASA (Hazard ratio (HR) 4.71, 95% Confidence interval (CI): 2.04–10.8). The risk of colectomy among (ii) patients intolerant to first 5-ASA but tolerant to other 5-ASA showed no significant difference compared with (i) tolerant to first 5-ASA (HR 0.76, 95% CI: 0.43–1.35). The biologics induction rate in (iii) patients withdrawal of 5-ASA was significantly higher than (i) tolerant to first 5-ASA and (ii) intolerant to first 5-ASA but tolerant to other 5-ASA (37%, 18%, 16%, respectively). Also (iii) patients withdrawal of 5-ASA showed higher risk of induction with biologics compared with (i) tolerant to first 5-ASA (HR 2.35, 95% CI: 1.50–3.68). Those risk among (ii) patients intolerant to first 5-ASA but tolerant to other 5-ASA showed no significant difference compared with (i) tolerant to first 5-ASA (HR 0.76, 95% CI: 0.43–1.35). ConclusionPatients with UC who had 5-ASA intolerance and withdrew from 5-ASA showed poor prognosis. We should consider trying other 5-ASA compounds even if the patients had intolerance to one 5-ASA compound.

    更新日期:2020-01-17
  • P258 Managing an ever-increasing inflammatory bowel disease helpline service
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Scott G, Gower L, Roads N, et al.

    BackgroundInflammatory bowel disease helplines have been initiated by Trusts throughout the country over many years. However many of them are not adequately job planned and have also seen a dramatic rise in calls over the years. Our Trust operates a helpline over 3 acute hospital sites. Previously calls were not accounted for financially and calls not documented in patient notes. MethodsThe nurses on each site utilise a standard form that notes the issues that patients contact the helpline for and the outcome of the call. The consultation is then dictated via a speech recognition system and a letter is generated and sent to the general practitioner. All calls are then added to a central spreadsheet which then categorises the calls into flare advice, medicines advice, investigation issues, appointment issues, etc.. The time that the call takes is also noted, to enable better job planning. ResultsThe monitoring of these helpline calls have enabled the team to employ 2 further IBD nurses as the income generated has paid for them. It has also enabled better job planning and it has highlighted the increased number of calls that are taken by the nursing team and that they have been safely managed and accounted for. it has also enabled the team to trend the calls that are taken and the reasons why patients phone our helplines. ConclusionThis project has shown a dramatic increase in activity for the IBD nurses. It has also highlighted the financial activity of the service and the contribution this provides to the gastroenterology department. This audit has since been utilised by the South East IBD Network.

    更新日期:2020-01-17
  • P056 Kefir (Lactobacillus kefiranofaciens) promotes autophagy and protects the intestinal barrier against DSS-induced colitis
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Da Silva K, Cordeiro T, Fávero A, et al.

    BackgroundInflammatory bowel disease occurs when luminal antigens from microbiota stimulate the immune system of an intestinal barrier through defects in the tight junctions lead to an exacerbated response in the genetically predisposed individual. It is well known that the consumption of probiotics improves intestinal health. Specifically, the Lactobacillus sp. strains play a key role in the epithelial intestinal barrier, promote mucin secretion, better performance of tight junctions and prevent apoptosis of epithelial cells. This study aimed to evaluate the role of Kefir (Lactobacillus kefiranofaciens) on inflammation of dextran sodium sulphate (DSS)-induced colitis. MethodsForty male Wistar rats were randomised into five groups: Sham; 5% DSS-induced colitis; control Kefir; 5% DSS-induced colitis treated with Kefir; 5% DSS-induced colitis treated with Kefir + 5-ASA (125mg/kg/day) (Ethics Committee on the Use of Animals number 3627290119). The lactic culture of Kefir (Danisco Biolacta, Olstyn, Poland) was administered ad libitum per 6 days. The preparation of the matrix was carried out as follows: whole milk powder was reconstituted to 10% with distilled water and was incubated at 85°C for 15 min using a mechanical shaker. Subsequently, 20 mg freeze-dried Kefir culture was added to 100 ml of the treated milk and fermentation were carried out at 23°C for 16 h. When the desired pH of 4.6 was reached, the fermentation was stopped by cooling the flasks in ice bath and storing them under refrigeration at 4°C until utilisation. The rats were euthanised on day 9. Colonic samples were processed for transmission electron microscope (TEM) and conventional microscopy. Samples were analysed in a TEM EX II 1200 (JEOL, Japan) coupled to a digital camera system GATAN Orius (USA). Histopathological evaluation was performed by a pathologist under a light microscope. Parameters such as inflammation extent, regeneration and crypt damage were graded according to Dieleman et al.3 Statistical analysis was performed by one-way analysis of variance (ANOVA), followed by Tukey’s test using Graph Pad Prism (version 6.0). ResultsKefir treatment reduces the severity of DSS-induced colitis evidenced by decreased abdominal discomfort and rectal bleeding. Histologically, there was a significant decreased of colonic damage and preservation of goblet cells (p < 0.0001) compared with DSS-colitis control group (Figure 1). The effect of Kefir was also verified by TEM analysis at the ultrastructural level, demonstrating the tight junctions preserved, decreased of reticulum edema and increased of autophagosomes (Figure 2). ConclusionKefir promotes autophagy and protects the intestinal barrier against damage caused by DSS.

    更新日期:2020-01-17
  • P665 Which second-line biologic after anti-TNF failure during Crohn’s disease: Ustekinumab or vedolizumab, a multicentre retrospective study
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Rayer C, Roblin X, Laharie D, et al.

    BackgroundAnti-TNF antibodies treatments are the only first-line reimbursed biologics for Crohn’s disease (CD) in several countries. Recently, Vedolizumab (VDZ) and Ustekinumab (UST) were added to the therapeutic armamentarium for CD refractory to a first anti-TNF antibody. However, studies comparing these two compounds remain unavailable. Our aim was to compare their efficacy in second-line treatment in CD after failure of one TNF antagonist. MethodsAll patients with CD refractory (primary or secondary non-responders) to first anti-TNF treatment and receiving UST or VDZ as a second biologic were included retrospectively in 10 French tertiary centres. The remission and clinical response were assessed at week 14. On the long-term, the cumulative probabilities of being in remission were estimated using the Kaplan–Meier method and the associated factors using a Cox proportional risk model. The drug survival to assess efficacy as well as side effects was assessed by actuarial analysis. Results88 patients were included, 50 (57%) females (mean age: 41 ± 15 years), 61 (69%) being treated with UST and 27 (31%) with VDZ. The first anti-TNF was discontinued for primary or secondary non-response in 66 (75%) patients and for side effects in 22 (25%) patients, without any difference between the anti-TNF antibody previously used. Among the 55 patients with endoscopic data at baseline, 55 (98%) had ulceration, a CRP above 5mg/l for 33/71 (46%) patients and a faecal calprotectin > 250 µg/g for the 12 patients tested. At week 14, no difference was observed for clinical response and clinical remission according to the type of treatment: the rate of clinical response and remission were 74% (UST)/58% (VDZ) (p = 0.20) and 33% (UST)/26% (VDZ) (p = 0.56), respectively. The only factor associated with short-term remission was the lack of optimisation prior to anti-TNF discontinuation (p = 0.038) regardless of the type of second-line therapy (UST, p = 0.02; VDZ, p = 0.03). After a mean follow-up of 67 weeks, the cumulative probabilities of being in remission at 6 and 12 months were 16% and 34% for UST and 25% and 44% for VDZ, respectively (p = 0.24 for UST vs. VDZ). The drug survival was higher in the UST group as compared with the VDZ group (HR (UST vs. VDZ) = 2.36 [1.02–5.5], p = 0.04). ConclusionOur preliminary results suggest that VDZ and UST have similar efficacy in the short- and long-term response when used as a second-line biologic therapy in CD refractory to a first anti-TNF antibody. These results will be complemented for the congress by the inclusion of additional patients recruited into this registry.

    更新日期:2020-01-17
  • P563 Shared decision-making in pregnancy in inflammatory bowel disease: Design of a pregnancy in IBD decision aid (PIDA)
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Williams A, Leung Y, O’Connor K, et al.

    BackgroundA lack of IBD-specific reproductive knowledge has been associated with increased ‘voluntary childlessness’.Furthermore, a lack of patient and clinician knowledge may contribute to inappropriate medication changes during or after pregnancy that may lead to a flare of disease. Evidence exists for the benefit of decision aids to support decision-making in pregnancy in general, as well as in multiple other chronic disease; however, such a resource for pregnancy in IBD has not been identified. MethodsUsing International Patient Decision Aids Standards, we have commenced design of our Pregnancy in IBD Decision Aid (PIDA). A steering committee consisting of Canadian and Australian Healthcare professionals with an interest in IBD management in pregnancy, in addition to a patient representative was established. Initial patient and clinician focus groups were conducted. Themes prospectively chosen for discussion included inheritance, fertility, nutrition, medications, mode of delivery, breastfeeding, infant infections and vaccinations. We designed an electronic PIDA draft that incorporates individualised information (for example, type of IBD, pre-conception or pregnant, surgical history and current medications) in personalised decision-making. Further patient focus groups and interviews were conducted to obtain user opinion of the PIDA draft. ResultsIn July 2017, patient and clinician focus groups were conducted at a Canadian site. Patient concerns regarding pregnancy included the impact of disease, previous surgical history on fertility, preterm delivery; the potential impact of current and past drug therapies on the fetus/ infant; and the negative impact of active disease on both maternal and fetal/infant health. Clinician concerns included the absence of pre-conception counselling and potential for lack of patient understanding about the impact of disease activity and IBD medication use in pregnancy. Patient feedback (n = 15) obtained through interviews at two Canadian and one Australian site regarding the current electronic PIDA draft was predominantly positive, with comments pertaining to the adequacy of content coverage, personalisation, readability and unbiased information presentation. Suggestions were made for inclusion of further content such as the impact of IBD on sexual function, expected laboratory changes and the timing of recommencement of medications post-partum. ConclusionThe completion of pre and post-PIDA design focus groups and interviews affirmed the role for PIDA. Main decisions that were considered necessary to address included ideal timing of conception pending disease activity, management of medications and delivery methods. Ongoing user feedback is being obtained at Australian and Canadian sites currently.

    更新日期:2020-01-17
  • OP04 Long-term outcomes after ileocolonic resection in Crohn’s disease according to the severity of early endoscopic recurrence
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Hammoudi N, , Auzolle C, et al.

    BackgroundEarly ileocolonoscopy within the first year after surgery is the gold standard to evaluate post-operative recurrence after ileocolonic resection for Crohn’s disease (CD). The aim of the study was to evaluate the association between lesions at ileocolonoscopy 6 months after surgery and long-term outcomes. MethodsThe REMIND group conducted a prospective multicentre study. Patients operated for ileal or ileocolonic CD were included. An ileocolonoscopy was performed 6 months after surgery. An endoscopic classification separating anastomotic and ileal lesions was built (Ax for anastomotic lesions; Ix for neo-terminal ileum lesions evaluated according to the Rutggerts score). Clinical relapse was defined by CD-related symptoms confirmed by imaging, endoscopy or therapeutic intensification, CD-related complication or subsequent surgery. ResultsA total of 225 patients were included. Long-term data were available for 193 patients (86%). Median follow-up was 3.82 years (IQR:2.56–5.41) from surgery. Median clinical recurrence-free survival was 47.6 months. Clinical recurrence-free survival was significantly shorter in patients with ileal lesions at early post-operative endoscopy whatever their severity (I1 or I2I3I4) compared with patients without (I0) (median survivals: 68.5, 33.0 and 39.1 months, respectively, for I0, I1 and I2I3I4; I0 vs. I2I3I4: p = 0.0003; I0 vs. I1: p = 0.0008 and I1 vs. I2I3I4: p = 0.43). Patients with at least semi-circumferential anastomotic ulcerations (A2 or A3) had more anastomotic occlusive manifestations than patients without (A0 or A1) (A0 vs. A2A3: p = 0.01; A0 vs. A1: p = 0.83; A1 vs. A2A3: p = 0.05). ConclusionA classification separating anastomotic and ileal lesions might be more appropriate to define post-operative endoscopic recurrence. Patients with ileal lesions, including mild ones (I1), could beneficiate from treatment step up to improve long-term outcome.

    更新日期:2020-01-17
  • P360 Safety and clinical efficacy of double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicentre study
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Mazza S, Fascì A, Casini V, et al.

    BackgroundSince infliximab (IFX) patent expiry in 2015, several IFX biosimilars have been licensed in EU for all indications, including inflammatory bowel diseases (IBD). IFX biosimilars currently available in Italy include CT-P13 and SB2, both of which demonstrated comparable efficacy, safety and immunogenicity with IFX originator in IBD patients. Safety and clinical efficacy of single switch from originator IFX to CT-P13 have also been confirmed in a prospective clinical trial. On the contrary, data regarding multiple therapeutic switching of IFX originator with CT-P13 and SB2 are currently lacking. MethodsThis study was aimed to evaluate the safety and efficacy of double switch from IFX originator to CT-P13 and subsequently to SB2 in patients with IBD. From November 2018 to May 2019, patients undergoing IFX double switch in 8 Centres in Lombardy were retrospectively analysed. The overall rate of IFX discontinuation, incidence and type of adverse events (AE) and proportion of patients on clinical remission over time were recorded. Data were compared with a control group of 66 IBD patients single switched from IFX originator to CT-P13. ResultsFifty-two double-switched IBD patients were enrolled (63% M, mean age 41 years, 75% Crohn’s disease, 25% ulcerative colitis). Main indications for IFX therapy were moderate to severe disease (50%) and steroid-dependent disease (25%). The overall 24- and 48-week IFX discontinuation rates following second switch (CTP13->SB2) were 2% (95% CI 0–6%) and 14% (95% CI 3–25%), respectively. During a median follow-up of 40 weeks (18–48), 4 patients (12%) experienced a total of 6 AE (2 cutaneous, 2 infectious, 1 articular and 1 immunological), leading to IFX discontinuation in 3 cases (6%). No infusion reactions were observed. At week 24 following second switch, 49 (94%) patients were in clinical remission, the remaining 3 patients not being in remission already at the time of second switch. Only one patient lost response after week 24, 48 (92%) of patients being in clinical remission at the end of follow-up. No differences in IFX discontinuation, AE and clinical remission rates were found between double-switched and single-switched patients. No clinical parameters were found to predict safety and efficacy outcomes. ConclusionThe study supports both safety and efficacy of the double switch from IFX originator to CT-P13 and SB2 in patients with IBD, and demonstrates its non-inferiority to a single switch strategy, with potential cost implications.

    更新日期:2020-01-17
  • P766 ABO blood groups and ulcerative colitis: A hospital-based study in central Taiwan
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Lai H, Chou J, Cheng K, et al.

    BackgroundThe variations in ABO blood groups are reported to be associated with multiple disorders. Ulcerative colitis (UC) is a chronic and relapsing disease of the gastrointestinal tract with unclear etiology. The incidence and prevalence of UC are low but increasing in Taiwan The aim of our current study was to investigate the distribution of ABO blood groups in patients with UC and to explore its impact on disease severity. MethodsFrom January 2000 to November 2019, we retrospectively collected patients diagnosed as UC in our hospital, a tertiary referral center in central Taiwan. Clinical characteristics of patients with UC including gender, age at diagnosis, ABO blood groups, disease phenotype and behaviour, operation rate and baseline laboratory data were collected. ResultsA total of 129 patients with UC were enrolled into our current study (Table 1). We found out male predominance as 62.8% of all patients. The mean diagnostic age of all UC patients was 39.0 years. Of 129 UC patients, 43 (33.3%) were blood type O, 41 (31.8%) were blood type A, 38 (29.5%) were blood type B, and the remainders 7 (5.4%) were blood type AB. However, there was no significant association between the ABO blood groups and UC patients compared with the general population of Taiwanese1 (p = 0.1906) (Table 2). In the subgroup analysis of each blood type, there were no significant difference of disease location and operation rate between groups. Furthermore, blood type A UC patients had higher hemoglobin level compared with blood type O patients (13.31 g/dl vs. 12.30 g/dl, p = 0.0347). Blood type A UC patients had lower erythrocyte sedimentation rate (ESR) level compared with blood type O patients (12.46 mm/h vs. 21.5 mm/h, p = 0.0288). Blood type O UC patients had the highest ESR level compared with non-O groups (p = 0.0228) (Table 3). We analysed the characteristics of UC patients between the diagnostic age older or younger than 40 years. However, there were no significant difference between two age groups (Table 4). ConclusionABO blood groups were not associated with the prevalence of UC, although UC patients with blood type A had the higher prevalence in our current study compared with the general populations with blood type A. UC patients with blood type O had higher baseline ESR level. UC patients with blood type A had higher baseline hemoglobin level.

    更新日期:2020-01-17
  • P159 Histopathological findings of preclinical inflammatory bowel disease
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Rodríguez-Lago I, Merino O, Azagra I, et al.

    BackgroundThe diagnosis of inflammatory bowel disease (IBD) is usually established after the development of symptoms, but preclinical disease may be present years before the final diagnosis. Recently, histology has become one of the main outcomes of IBD treatment. The primary aim of our study was to define the main histological findings of preclinical IBD and its association with the natural history of the disease. MethodsThis multicentric, retrospective study included all patients who participated in the colorectal cancer screening programme in 11 centres between 2009–2014. All patients were firstly assessed by a faecal immunochemical test (OC-Sensor, Eiken Chemical Co., Tokyo, Japan) and, if this test was positive (cut-off 20 μg Hgb/g), a colonoscopy was performed. All patients had an incidental diagnosis of IBD confirmed by histology, according to current ECCO criteria, during a screening colonoscopy. Three histologic findings were evaluated at diagnosis: presence of granuloma, crypt abscesses and/or eosinophilic infiltrate. The main outcomes were the development of symptoms and the risk of proximal disease extension. The frequency of each finding was described separately by IBD subtype and the chi-square test was used to describe possible association with the main outcomes. ResultsDuring this period we performed 31,005 colonoscopies after 498,227 FIT. Finally, 110 patients were included with an incidental diagnosis of ulcerative colitis (UC, 79 cases), Crohn’s disease (CD, 24 cases) or IBD-Unclassified (IBD-U, 7 cases). Crypt abscesses were present in 56%, 33% and 57% of UC, CD and IBD-U patients, respectively (Figure 1). An eosinophilic infiltrate was observed in 27%, 25% and 57% of patients, respectively. Granuloma were only observed in 4% of CD patients. There were no statistically significant differences in these findings according to IBD subtype (p = 0.14, 0.22 and 0.17 for crypt abscesses, eosinophilic infiltrate and granuloma, respectively). After a median follow-up of 25 months (IQR, 11–42), 36% of patients developed symptomatic disease. Neither of the histological findings were associated with a higher risk of developing symptomatic disease (p = 0.29, 0.78 and 0.3, respectively). No patient showed proximal extension of UC. ConclusionPreclinical IBD is frequently associated with the presence of crypt abscesses, especially in UC. Granuloma is probably a late finding in CD. Around one third of patients show a eosinophilic infiltrate in the early phases of the disease.

    更新日期:2020-01-17
  • P462 Efficacy of ustekinumab for the prevention of postoperative recurrence in crohn’s disease. Data from clinical practice from the eneida registry
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Mañosa Ciria M, Fernandez-Clotet A, Hernández-Camba A, et al.

    BackgroundAnti-TNF and thiopurines are the only drugs that demonstrated efficacy in preventing postoperative recurrence (POR) in Crohn’s disease (CD). However, in some cases these drugs are contraindicated or have previously failed. Recently, ustekinumab was licensed for CD but no data on its efficacy in the prevention of POR is still available. MethodsAll CD patients in whom ustekinumab was prescribed for primary prevention of POR within the first 3 months after ileocecal or ileocolonic resection with anastomosis were identified from the ENEIDA registry (a prospectively maintained database of the Spanish Working Group in IBD –GETECCU-). We evaluated the rates of endoscopic, clinical or surgical POR in the first 18 months. Endoscopic POR was defined by a Rutgeerts score >i1 and advanced endoscopic POR by >i2. ResultsThirty patients were included; ustekinumab was started after a median time of 60 days (IIQ 31–90). Concomitant immunosuppressants were used in 17%, 27% received an additional 3-month course of metronidazole after surgery. Regarding risk factors for POR: 23% were active smokers, 62% had prior resections, 33% had penetrating CD behaviour, and 22% had a history of perianal disease. In total, 36% of them had more than one risk factor. 50% had been exposed to ustekinumab prior to the index surgery (46% within the last 6 months). The median time of follow-up on ustekinumab was 17 months (IQR 11–21). Fifty-six per cent of patients had at least one endoscopic assessment within 18 months after surgery: 58% had endoscopic POR and 23% advanced endoscopic POR. Additionally, 13% presented clinical POR at the discretion of the treating physician and none developed surgical POR. ConclusionIn a small clinical practice cohort, ustekinumab showed similar efficacy as that reported with anti-TNF in the prevention of endoscopic POR. Unfortunately, the lack of early endoscopic monitoring is still frequent despite the recommendations from guidelines.

    更新日期:2020-01-17
  • N19 Understanding the emotional impact of inflammatory bowel disease: looking after nurses looking after patients
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Younge L, Medcalf L, Hall A, et al.

    BackgroundThe emotional impact of inflammatory bowel disease (IBD) is well documented. Patients describe distress, anxiety, depression and relationship difficulties, (including with healthcare staff). Nurses working with IBD patients report being emotionally affected, with fears of ‘burnout’, feeling unable to respond helpfully to patients and feelings of guilt, frustration, sadness and anger. Understanding and managing the emotional impact of the work for IBD nurses is an area underrepresented in either research or nursing literature. MethodsA collaborative project with IBD nurses and nursing and psychotherapy colleagues from the Tavistock and Portman NHS Foundation Trust developed a one-day event for IBD nurses in the UK. Attendees were self-selecting and the event was supported by Pharma. The conference had three aims: To provide an opportunity to recognise and understand the emotional impact on nurses working with IBD patients, to provide a networking opportunity, and to use information gathered before, during and after the conference to develop a clearer understanding of nurses’ experiences and needs. A pre-conference questionnaire was sent to attendees, observations were made during the conference (noting themes and dilemmas) and an evaluation form was provided. Results89% agreed/strongly agreed the event provided understanding of how IBD can have an emotional and psychological impact on patients. 89% agreed/strongly agreed the event provided understanding of the emotional impact on nurses working with IBD patients. Eighty-nine per cent agreed/strongly agreed the event provided understanding of ways in which the emotional impact can influence provision of care and decision making in patients with IBD. Ninety-three per cent agreed/strongly agreed the event provided them with ideas for establishing and managing reflective learning opportunities. Seventy-five per cent agreed/strongly agreed the event enabled them to identify different ways of responding to patients they work with. ConclusionFeedback from attendees identified a need and an expressed wish by IBD nurses to understand and explore how they are affected by their work, in relation to maintaining therapeutic and safe relationships with patients and maintaining their own well-being and job satisfaction. Learning needs relating to training in supervision, developing skills in responding to patients’ emotional states, tools for looking after one’s self and opportunities for group discussions and learning were identified. There is an opportunity to develop further learning and training events in relation to these identified needs. Further exploration of accessibility, funding and evaluation would be beneficial in identifying the impact, if any, of further training.

    更新日期:2020-01-17
  • P564 Psychological acceptance of surgery in patients with inflammatory bowel disease undergoing intestinal resection
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Hirano Y, Itabashi M, Saito T, et al.

    BackgroundTo decision to undergo surgical intestinal resection is among the most difficult that patients with inflammatory bowel disease (IBD) may be required to make during the disease course. Although the clinical outcomes and QoL after intestinal resection are well established, few studies have focused on psychological acceptance of the surgery, that is, how patients feel about the results of intestinal resection. The aim of this study was therefore to evaluate psychological acceptance of the surgical outcome in patients undergoing intestinal resection. MethodsWe administered a cross-sectional questionnaire survey to patients at five IBD centres in Japan who had undergone intestinal resection at least 1 month before the survey. Patients were asked to complete a visual analogue scale (VAS) questionnaire, consisting of 20 questions related to surgical acceptance and concerns related to IBD (body image, burden of treatment, interpersonal relationships), before and after surgery. The VAS scores before surgery were described by the patient looking back on recollection. Pre- and post-surgical VAS scores were compared using a Wilcoxon’s rank-sum test. ResultsA total of 64 patients participated in this study (median age at surgery 37.9 (range 12–67) years, median years after surgery 5.0 (range 0.1–21) years). The VAS scores before and after surgery were summarised in the figure. The score for ‘pleased to have surgical resection of my intestine’ improved significantly after the surgery in both UC and CD (p < .0001).Furthermore, the score for ‘burdened with treatment for my IBD’ improved significantly after surgery in UC patients (p < .0001). ConclusionOur findings indicate that surgical intestinal resection outcomes were psychologically well accepted by most IBD patients.

    更新日期:2020-01-17
  • P666 Neutropenia in inflammatory bowel disease patients on TNF inhibitors: A single-centre, retrospective cohort study
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    AlAskar D, Mais A, Al Sulais E, et al.

    BackgroundTumor necrosis factor-α inhibitors (TNFi) have become the mainstay of treatment in moderate to severe cases of IBD.The haematological safety profile of these agents has been documented in multiple clinical trials and post-marketing registries. Nonetheless, neutropenia has been reported in patients receiving TNFi for IBD and other diseases (Bessissow et al 2012).In this study, we aim to ascertain the relationship between the use of TNFi and the development of neutropenia in IBD patients. MethodsThis is a retrospective cohort study including all adult IBD patients receiving TNFi at our centre from the year 2007 to 2018. Our primary outcome was the development of any neutropenic episode after starting a TNFi. Neutropenia was defined as circulating absolute neutrophil count (ANC) less than 1500/mm3.For our secondary outcomes, we evaluated the impact of concomitant use of (5-ASA) or an immunomodulator on the risk of developing neutropenia. We also looked at the effect of baseline neutrophil and WBC counts on the subsequent development of neutropenia. ResultsA total of 292 patients met the inclusion criteria, 11 patients were excluded for not having neutrophil count done. The final analysis included 281 patients. The mean age of patients in this study was 33. Adalimumab was the most frequently prescribed TNFi. Of those included, 96 patients (34.2%) developed at least one episode of neutropenia while on a TNFi. The majority of these episodes (67.7%) were mild with ANC between 1000 and 1500/mm3. There was no significant difference in the age, gender, agent used or type of IBD between those who developed neutropenia and those who did not. On the other hand, baseline neutrophil count and concomitant use of azathioprine and 5-ASA were significant independent predictors of neutropenia after commencing TNFi. (Table 1).With neutropenia 96 (34.2%)Without neutropenia 185 (65.8%)P valueSex0.137Male45104Female5181Diagnosis0.072CD75160UC2125Azathioprine0.001No1974Yes771115-ASA0.0No59157Yes3728 ConclusionIn this study, mild neutropenia was common amongst IBD patients on TNFi. Patients were more likely to develop neutropenia if they have been on concurrent therapy with an immunomodulator or 5-ASA. Future prospective studies are required to further clarify the significance of neutropenia in IBD patients receiving TNFi.

    更新日期:2020-01-17
  • OP05 Validation of the Lémann index in Crohn’s disease
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Pariente B, Torres J, Burisch J, et al.

    BackgroundThe Lémann index (LI) is the first instrument developed to measure cumulative structural bowel damage in Crohn’s disease (CD).1 We here report its validation. MethodsThis was an international, multicentre, prospective cross-sectional observational study. At each centre, 10 inclusions, stratified by known or suspected CD location and duration, were planned. Clinical examination and abdominal MRI had to be performed in all patients, and upper endoscopy, colonoscopy, and pelvic MRI according to CD location. Upper tract (UT), small bowel (SB), colon/rectum (CR), and anus (AN) were divided into 3, 20, 6 and 1 segments, respectively. History of previous surgery was collected per segment. For each segment, 1 gastroenterologist and 1 radiologist per centre, identified the presence of predefined stricturing and/or penetrating lesions of maximal severity (grade 1 to 3) at each investigation. They provided a damage evaluation for each non-resected segment ranging from 0 to 10, 10 corresponding to the damage of a completely resected segment. Investigator organ damage evaluation was calculated as the sum of segmental damage evaluations. Finally, investigators provided a global damage evaluation from 0 to 10 for each patient according to the 4 organ damage scores, calculated as a function of investigator organ damage evaluations, resections and a total number of segments. The correlation between the investigator global damage evaluation and the LI was high on the construction sample, since coefficients to derive the LI were estimated by maximising this correlation, and is expected to be lower on data obtained in new patients by new investigators. Thus, the LI would be validated if the linear regression model of investigator global damage evaluation on LI shows a still high correlation. The same applies to investigator damage evaluation of each organ and each organ component of the LI. Results134 patients were included in 15 centres, 7 to 10 per centre. Correlation coefficients between investigator organ damage evaluation and each organ component of the LI were 0.91, 0.96, 0.95, and 0.81, for UT, SB, CR and AN, respectively. The correlation coefficient between investigator global damage evaluation and the LI was 0.98 (Figure 1). Proportions of the investigator organ damage evaluation variance explained by each organ component of the LI were 82%, 91%, 89%, 65%, for UT, SB, CR, AN, respectively. This proportion was 96% for the investigator global damage evaluation and the LI. ConclusionThe Lémann index is now a validated index to assess cumulative bowel damage in CD that can be used in epidemiological studies and disease modification trials. Reference Pariente B et al., Gastroenterology, 2015;148(1):52–63.

    更新日期:2020-01-17
  • P361 The effect of immunomodulators and other factors on the persistence of biological agents for Crohn’s disease and ulcerative colitis: data from the Australian population-based registry
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Ko Y, Paramsothy S, Leong R.

    BackgroundTreatment persistence (duration of medication use) provides real-world evidence on therapeutic effectiveness, tolerability and prescriber and patient preferences. Biological agent persistence in Crohn’s disease (CD) and ulcerative colitis (UC) was compared from a national population-based registry with no hierarchical prescribing order. We hypothesised immunotherapy co-therapy would increase persistence for anti-TNF agents, but not for non-anti-TNF agents due to reduced immunogenicity. MethodsA randomly selected ten per cent subgroup of the prospectively collected population-based registry from the Australian Pharmaceutical Benefits Scheme between June 2005 and June 2019 was analysed. Treatment persistence of adalimumab (ADA), infliximab (IFX), vedolizumab (VDZ) and ustekinumab (UST) was compared. Factors affecting discontinuation were evaluated using multivariate proportional hazard regression. Results886 patients consisting of 1294 lines of therapy (992 CD, 302 UC, 2778 person-years of follow-up) were included. In CD, UST had the highest overall persistence rate (median persistence rate was > 74.6% where 24.6 months is the maximum follow-up time recorded), followed by VDZ, IFX and ADA (p = 0.03) (Figure 1). UST had the highest persistence as first, second and third-line therapies (p < 0.05). In UC, VDZ had the highest persistence rate (median persistence rate was >50.3% where 47.4 months is the maximum follow-up time recorded), followed by IFX and ADA (p < 0.001) (Figure 2). VDZ had the highest persistence rates as first-line therapy (p < 0.001), while second and third-line therapies did not demonstrate significant differences.Persistence of biological agents correlated with immunomodulator co-therapy in CD (R2: 0.65 p < 0.001) and UC (R2: 0.50 p < 0.001). Thiopurine co-therapy significantly increased persistence for IFX and ADA in CD and UC (p < 0.001) (Figures 3 and 4) but was not significant for UST and VDZ. Methotrexate decreased persistence for VDZ in UC and had no effects on UST, IFX and ADA in UC and CD. In acute-severe UC, there were no significant differences between IFX as monotherapy vs. co-therapy.On multivariate analysis, higher persistence was seen in males (HR: 0.75 95% CI: 0.59–0.94) and with immunomodulator co-therapy (HR 0.77 95% CI: 0.61–0.97, p = 0.03). ConclusionThis real-world data reflecting treatment effectiveness, tolerability and patient and prescriber preferences supports the use of UST and VDZ over anti-TNF agents in CD and UC, respectively, to achieve high treatment persistence which is independent of immunomodulator co-therapy, possibly secondary to differing immunogenicity rates. It also highlights the substantial increase in anti-TNF therapy persistence with thiopurine co-therapy, but not with methotrexate.

    更新日期:2020-01-17
  • P767 Prevalence and incidence rates of inflammatory bowel disease among First Nations: Population-based evidence from Saskatchewan, Canada
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Peña-Sánchez J, , Jennings D, et al.

    BackgroundWorldwide, the epidemiology of inflammatory bowel disease (IBD) has been widely studied in the general population; however, there is limited-to-no evidence about IBD among Indigenous peoples, specifically among First Nations (FNs). Saskatchewan (SK) is a province in western Canada with a population of 1.1 million, 11% of whom are FNs. We aimed to estimate the prevalence, incidence, and trends of IBD among FNs in SK since 1999. MethodsAs part of a patient-oriented research project, we conducted a retrospective population-based study between 1999 and 2016 fiscal years using administrative data for the province of SK. A previously validated algorithm that required multiple health care contacts was applied to identify IBD cases (Crohn’s disease [CD] and ulcerative colitis [UC]). The ‘self-declared FN status’ variable in the Person Health Registration System was used to determine FNs meeting the IBD case definition and the population at risk. Generalised linear models (GLMs) with generalised estimated equations and a negative binomial distribution were used to estimate the annual prevalence of IBD, CD, and UC. Incidence rates and their corresponding 95% confidence intervals (95%CI) were estimated using GLMs with a negative binomial distribution. The GLMs were used to test trends overtime. ResultsThe annual prevalence of IBD among FNs in SK increased from 64 (95%CI 62–66) per 100,000 people in 1999 to 142 (95%CI 140–144) per 100,000 population in 2016. Also, the prevalence of CD and UC increased during the study period, with 53/100,000 (95%CI 52–55) for CD and 87/100,000 (95%CI 86–89) for UC in 2016. The average increase in the prevalence of IBD was 4.2% (95%CI 3.2–5.2) per year, with similar trends observed in CD (4.1% [95%CI 3.3–4.9]) and UC (3.4% [95%CI 2.3–4.6]). The incidence rates of IBD among FNs were 11 (95%CI 5–25) per 100,000 people in 1999 and 3 (95%CI 1–11) per 100,000 population in 2016. No statistically significant changes were observed in the incidence rates over time (p = 0.09). ConclusionThis study is the first epidemiological work providing detailed evidence of IBD among FNs. We identified that FNs have increasing trends in the prevalence of IBD, which has also been described in the Canadian general population. In contrast to the general population of Canada and other developed countries that have shown decreasing trends, the incidence rates of IBD among FNs appear to be stable over time. Also, among FNs, UC appears to be more prevalent than CD; this pattern has been observed in the general populations of developing countries. These results illuminate the need to advocate for better health care and wellness for FNs living with IBD.

    更新日期:2020-01-17
  • P160 A novel PillCam Crohn’s capsule score (Eliakim score) for quantification of mucosal inflammation in Crohn’s disease
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Eliakim R, Yablecovitch D, Lahat A, et al.

    BackgroundCapsule endoscopy (CE) is an important modality for monitoring of Crohn’s disease (CD). We recently established that small bowel (SB) inflammation on CE quantified by a Lewis score >350 accurately predicts risk of relapse within 2 years in CD patients in clinical remission. Recently, a novel pan-enteric capsule (PillCam Crohn’s (PCCE), Medtronic, USA) was approved for use. However, no quantitative index for pan-enteric PCCE is currently available. The current study was undertaken as a sub-study of a prospective randomised controlled CURE-CD trial aiming to optimise treatment of CD patients in remission using a PCCE- based treat-to-target approach; the aim of this ancillary study was to compare the correlation and reliability of the novel PCCE inflamatory score (Eliakim score) with the Lewis score as performed by 2 independent experienced CE readers. MethodsThe study cohort includes CD patients in clinical remission (CDAI<150). The patients were prospectively enrolled and underwent patency capsule evaluation; if excreted within 30 h, PCCE was performed following bowel preparation. PCCE was repeated every 6 months; if no colonic disease was detected on first PCCE, subsequent examinations were performed without colonic preparation. Each PCCE was independently reviewed by 2 experienced readers (RE (reader 1);UK (reader 2)). All studies were scored using the Lewis score and Eliakim score (comprised of a sum of scores for most common and most severe lesions multiplied by percentage of involvement per bowel segment (3 for small bowel and 2 for colon) with an additional stricture score). Pearson’s and Spearman’ correlation, Cohen’s kappa and inter-rater reliability coefficient (IRC) between the scores and the readers were calculated as appropriate. ResultsForty PCCE exams were included. The median LS was 225 for both readers (interquartile range (IQR)—157–815 for reader 1, 33- 1125 for reader 2). Both readers identified significant SB inflammation (LS>350) in 17/40 (42.5%) of the patients with strong agreement between the readers (Spearman’s r = 0.87, p < 0.0001). The median PCCE score was 6 (4–14.75) and 4 (2–14.75) for reader 1 and 2, respectively. There was a high IRC between the two readers for LS (0.88, p < 0.0001 for absolute agreement) and PCCE score (0.91, p < 0.0001). For the small bowel, the correlation between LS and PCCE was moderate for reader 1 (Pearson’s r = 0.72, p < 0.0001 and strong for reader 2 Pearson’s r = 0.84, p < 0.0001). ConclusionThere is a need for a quantitative pan-enteric score for the novel Pillcam Crohns capsule. The presently proposed score, while mandating further clinical validation, has strong inter-reader reliability and moderate-to-strong correlation with the validated small bowel capsule score (LS)

    更新日期:2020-01-17
  • P259 Systematic review of prognostic factors affecting the acquisition of transition readiness skills in patients with inflammatory bowel disease
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    JOHNSON L, Lee M, Jones G, et al.

    BackgroundAround 25% of patients with inflammatory bowel disease (IBD) are diagnosed before the age of 20, meaning transition from paediatric to adult healthcare is inevitable for some. Good transition is important to maintain quality of care, and poor transition can result in adverse outcomes such as clinic and medication non-adherence. Certain skills are required in order for someone to be ready to transition, and the aim of this study was to identify modifiable and non-modifiable factors affecting the development of these skills in young people with IBD. MethodsThis review was registered on the PROSERO database (CRD42019152272) and conducted in line with PRISMA guidelines. Studies were included if they (1) explored factors affecting the acquisition of transition readiness skills in IBD patients 2) were written in English (3) were published since 1999. The databases MEDLINE, CINAHL and PsychINFO were searched from September - October 2019. Bias was assessed using the Quality in Prognostic Studies tool. ResultsSearches identified 822 papers and 27 full texts were retrieved. Sixteen papers were included in the final review, reporting on 1770 patients ranging from 10–29 years of age. Fourteen studies were cross-sectional and two longitudinal. Six assessed transition readiness, five self-management, two disease knowledge, one medication knowledge, one health literacy, and one both disease knowledge and self-management. Modifiable factors found were increased provider-communication about transition, transition duration, and health care satisfaction. Participant self-efficacy was found to be significant for three studies, and increased parent autonomy granting was related to higher disease knowledge in one study. Non-modifiable factors identified were age, sex, socioeconomic score, participant educational level and ethnicity. Nine studies showed increased age as a positive prognostic factor, and two additional papers found an effect for certain domains assessed. Four studies showed higher scores for females, and one study demonstrated higher self-rated self-efficacy scores for males. Disease-related non-modifiable factors identified were IBD family history, age at diagnosis, and absence from school. ConclusionThis study identified five potentially modifiable factors. Strategies or interventions to address these in the IBD population transitioning to adult care might lead to improved experience and outcomes. This review also identified eight non-modifiable factors. This may allow healthcare and allied professionals to identify those at an increased risk of not developing the necessary competencies for transition and adapting the way in which they approach transition for each individual.

    更新日期:2020-01-17
  • P057 IL-17 regulates expression of chemotactic chemokines in human colonic subepithelial myofibroblasts
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Filidou E, Tarapatzi G, Boulkou M, et al.

    BackgroundCrohn’s disease (CD) and ulcerative colitis (UC), the two main entities of inflammatory bowel disease (IBD), are characterised by chronic and relapsing/remitting inflammation of the gastrointestinal tract, and occasionally ultimately result in debilitating intestinal fibrosis. Apart from their key role in fibrosis, there is evidence that subepithelial myofibroblasts (SEMFs) participate in the IBD inflammatory cascade, as they express various pro-inflammatory cytokine receptors. We examined the effect of pro-inflammatory IL-17—the hallmark cytokine of T-lymphocytes differentiated to Th17—on the expression of lymphocyte-chemotactic chemokines in SEMFs. MethodsSEMFs were isolated from endoscopically obtained colonic biopsies from healthy controls, set to culture and stimulated with 100 ng/ml IL-17 for 6 h. Total RNA was extracted and mRNA expression of CCL5, CXCL1 and CXCL11 was assessed with reverse transcription quantitative (RT-q) PCR. Changes in cytokine mRNA are provided as medians (IQR). ResultsUntreated SEMFs had a basal expression of chemokines of the CCL and CXCL family groups. So far, our study has shown that the IL-17 stimulation leads to a statistically significant upregulation of CCL and CXCL chemokines in SEMFs (p < 0.001). In detail, CCL5 was upregulated 5.7-fold (4.9–7.5), CXCL1 72.9-fold (63.1–90.7) and CXCL11 25.4-fold (17.3–37.3). ConclusionIL-17 induced the expression of chemotactic factors in SEMFs. Our results further support a potential role of SEMFs in the shaping of intestinal mucosal immunity by serving as immunological intermediates that respond to cytokines of adaptive immunity and amplify the recruitment of immune cells via chemokine production.

    更新日期:2020-01-17
  • N20 The impact of inflammatory bowel disease-related fatigue on health-related quality of life: a qualitative semi-structured interview study
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Radford S, Moran G, Czuber-Dochan W.

    BackgroundFatigue is a frequently reported symptom of inflammatory bowel disease (IBD), experienced by patients with active disease and in remission. Fatigue related to chronic conditions plays a significant negative role in Health-Related Quality of Life (HRQoL), but patients’ experience of this have not been researched in IBD. We aimed to explore experience of IBD fatigue and its impact on HRQoL in adults diagnosed with IBD. MethodsQualitative, semi-structured in-depth interviews were conducted with adults with IBD in remission, recruited from out-patient clinics in the UK. Eligibility and medical history were confirmed at recruitment. Interviews were audio-recorded and transcribed verbatim. Thematic analysis was employed to analyse the data using NVivo 12 software. ResultsFourteen participants (eight female, average age 37.3 years old, range 21–64) were interviewed. All identified as ‘White British’, average length of living with IBD fatigue was 10.9 years (range 9 months–17 years). Twelve participants reported constant fatigue and two reported intermittent fatigue. There were three key themes reflecting patient experiences: (1) ‘The new normal’ established through attempts to adapt daily life and acceptance of IBD fatigue impact on daily life and HRQoL. HRQoL is negatively impacted by lack of feelings of fulfilment, not being able to continue on as before the onset of IBD fatigue and a negative perception of self in comparison to others without IBD fatigue; (2) ‘Energy as a resource’ describes participants attempts to better manage fatigue on a daily basis through planning and prioritising tasks, often prioritising employment or education over social or leisure activities; (3) ‘Keeping healthy’ encompasses participants beliefs that good nutrition, good general health and keeping active allow them to generate energy more easily allowing some situational control where they have little control over IBD symptoms, subsequently improving HRQoL. Participants reported a mix of physical activities that improved HRQoL; however, none reported a specific programme of exercise. ConclusionAdults with IBD fatigue try to establish a sense of ‘new’ normality, through maintaining the same or similar, level of activities related to employment or education. However, this is often at the expense of personal, social and leisure activities. The study also indicates that perceptions of conservation of energy through planning and prioritising tasks and high levels of social support were associated with better self-reported HRQoL. Further research is required to explore physical activity-based intervention in relation to IBD fatigue, with use of validated fatigue and HRQoL measures.

    更新日期:2020-01-17
  • P463 Induction of endoscopic response: a network meta-analysis of induction studies comparing ontamalimab with other treatments for moderate-to-severe ulcerative colitis
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Vickers A, Nag A, Devine B, et al.

    BackgroundClinicians, patients, payers and policymakers require relevant, high-quality evidence to support decision-making regarding the treatment of ulcerative colitis (UC). In the absence of head-to-head trials, network meta-analysis (NMA) can be used to compare treatments. We conducted an NMA to compare the efficacy of ontamalimab (anti-MAdCAM-1) using its phase 2 data, with all biologics and novel small molecules for which induction study data on endoscopic response were available. MethodsA systematic literature review was conducted in November 2017 to identify published randomised controlled trials of induction treatment in patients with moderate-to-severe UC. An NMA of the identified studies was performed using random-effects models and methods based on NICE guidance. Odds ratios and 95% credible intervals were calculated to describe the relative differences between treatments and placebo in terms of efficacy in inducing endoscopic response. Results were examined by anti-TNF status (naïve vs. experienced). ResultsIn total, 15 phase 2 and phase 3 induction studies of the following agents were available and included: adalimumab (160/80mg), etrolizumab (100mg and 300mg), golimumab (200/100mg), infliximab (5mg), ontamalimab (22.5mg and 75mg), ozanimod (0.5mg and 1mg), tofacitinib (10mg) and vedolizumab (300mg). The definition of endoscopic response (improvement) in all trials was a Mayo endoscopic subscore of ≤1. Homogeneity between studies was good, enabling pooling of results. Figure 1 shows odds ratios for induction of endoscopic response with treatments relative to placebo in anti-TNF-naïve and -experienced patients. All treatments performed significantly better than placebo in anti-TNF-naïve patients, with the exception of both doses of etrolizumab and ozanimod 0.5 mg. Significant differences between some treatments were observed; specifically, ontamalimab 22.5 mg (p = 0.0277), tofacitinib 10 mg (p = 0.0233) and infliximab 5 mg (p = 0.0047) were all superior to adalimumab 160/80 mg. ConclusionThis study suggests that ontamalimab, infliximab and tofacitinib could be superior to adalimumab in inducing endoscopic healing, although it was conducted before any large-scale head-to-head trials of these drugs. Furthermore, large variances due to differing endpoint timings, the combination of phase 2 and phase 3 data, and lack of control for placebo response rates preclude firm conclusions being drawn.

    更新日期:2020-01-17
  • P565 Efficacy and safety of long-term treatment with ustekinumab in moderate–severe ulcerative colitis patients with delayed response to ustekinumab induction: Results from UNIFI 2-year long-term extension
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Sands B, , Abreu M, et al.

    BackgroundUstekinumab (UST) has been shown to induce and maintain clinical response and remission in moderate–severe UC patients in the UNIFI study. In the UNIFI maintenance study, the primary randomised population consisted of patients who were in clinical response 8weeks after UST induction treatment. Patients who had a delayed response to induction were also eligible for the maintenance study but were not included in the randomised analysis set. Here, we present the efficacy and safety of UST maintenance among delayed responders who were treated in the UNIFI long-term extension(LTE). MethodsUNIFI was a single protocol of induction and randomised withdrawal maintenance studies in patients with moderate–severe UC who failed conventional or biologic therapy(including TNF antagonists and/or vedolizumab). Delayed responders were patients who were not in clinical response to UST IV induction at Week8 but achieved response at Week16 following a single UST90mg SC dose at Week8. These patients entered the maintenance study and continued to receive UST90mg SC q8w. Patients who completed Week44 evaluations were eligible to enter LTE continuing to receive UST90mg SC q8w. Efficacy in delayed responders to UST(who were treated in LTE) was evaluated over time through Week92 and safety through Week96. Results116 delayed responders to UST induction were treated in the LTE, including 58 who had previously failed biologic therapy and 58 who had not failed biologic therapy, 54 of whom were bio-naïve. Symptomatic remission(defined as stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0) rates in delayed responders to UST induction increased from maintenance baseline to Weeks 44 and 92 (Table 1). Similar trends were seen within the biologic failure subgroups; although, rates among patients who had not failed biologics (primarily bio-naïve) were greater than those of patients who had failed biologics. Among the 79.3% (n = 92/116) of delayed responders to UST in symptomatic remission at Week 92, 94.6% (n = 87/92) were corticosteroid free. Safety data for randomised and non-randomised patients treated in UNIFI LTE is in Table2. The safety profile for UST in delayed responders was generally similar to that observed among patients randomised to UST; no new safety signals were observed. ConclusionDelayed responders to UST treatment maintained symptomatic remission through Week 92 with UST90mg SC q8w and the majority did so in the absence of corticosteroids.

    更新日期:2020-01-17
  • OP06 Comparison between Crohn and coeliac diseases small intestine transcriptomics and microbial data define similarities and divergent pathways linked to pathogenesis
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Haberman Ziv Y, , Loberman-Nachum N, et al.

    BackgroundCrohn disease and coeliac disease are two inflammatory conditions known to cause small intestine inflammation. Using high throughput transcriptomics, microbial, and bioinformatics approaches we aimed to capture differences and similarities linked to the pathogenesis and to future potential interventions for those chronic manifestations. MethodsWe performed high throughput transcriptomics and 16S microbial characterisation of 55 paediatric new-onset coeliac patients and controls using clinical pathology specimens, and compared those signatures to our previously reported 248 RISK Crohn’s disease newly diagnosed cohort. ToppGene/ToppCluster and ClueGO platforms were used for functional annotation enrichment analyses, and MaAsLin for microbial differential abundance. ResultsA substantial number (>90%) of genes passed the expression filtering criteria in both studies enabling the comparison. Of the 354 coeliac down-regulated genes, 59% (209/354) overlapped with the reduced Crohn signature. Shared reduced signatures and functions included a decrease in epithelial lipid metabolism, oxidoreductase activity, and brush border transport signatures. In contrast, a significantly smaller proportion [19% (97/427, Chi-squares p < 0.001] of the coeliac disease 524 up-regulated genes overlapped with the induced Crohn disease signature. We noted shared enriched signatures for adaptive immune-related pathways and interferon-γ in both coeliac and Crohn diseases. However, the Crohn disease signature exhibited more specific enrichments for signatures associated with innate immune pathways and with a strong signal for granulocytes, an extracellular matrix signature, and CXCR chemokines signalling, while the coeliac up-regulated signature showed unique enrichment for cell cycle and mitosis. As opposed to the robust dysbiosis previously characterised in Crohn disease, we were only able to identify significant enrichment for Bacteroidetes taxa in coeliac patients in comparison to controls. ConclusionWe highlight important biologic differences between Crohn and coeliac diseases emphasising an intensified innate granulocytes activation signature in Crohn disease and a specific epithelial proliferative signal in coeliac disease. Unlike the robust dysbiosis linked to Crohn disease, the coeliac patient showed only modest enrichment for several Bacteroidetes taxa in comparison to controls. It is possible that microbial alteration in Crohn disease triggers granulocytes activation, and that this signal inhibits epithelial proliferation/renewal, eventually leading the epithelial damage seen in Crohn but not coeliac disease. Inhibiting innate immune activation or reverting Crohn dysbiosis may be a beneficial future therapy for Crohn disease.

    更新日期:2020-01-17
  • P362 Prospective study of phArmaCokinetics of InFliximab during induction in patients with Crohn’s disease and ulcerative colitis (PACIFIC)
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Liefferinckx C, , Bossuyt P, et al.

    BackgroundLoss of response (LOR) to infliximab (IFX) remains a challenge in routine management of IBD patients. We evaluated IFX high-resolution pharmacokinetics (PK) during induction with intermediate and peak PK levels. MethodsThis is a prospective, multicentre (n = 9), interventional study approved by EC (P2017/484). Fourteen blood samples were collected per patient from baseline to week 30. All patients were IFX naïve with active disease according to clinical, biological and endoscopy criteria. The primary outcome evaluated the inter-individual variability of IFX PK during induction and correlation with remission at week 30. In addition to trough levels (TLs), intermediate (ILs) and peak levels (PLs) were also measured and defined as drug level between two infusions and drug level early on after infusion (+2h), respectively. Remission was defined as having a Harvey Bradshaw Index (HBI) ≤ 4 and C-Reactive Protein (CRP) ≤5 for Crohn’s disease (CD), and as a clinical Mayo score ≤2 and faecal calprotectin <250 µg/g for ulcerative colitis (UC). IFX samples were measured by ELISA (Apdia) while a drug-tolerant affinity capture elution anti-infliximab assay was used to measure anti-infliximab antibodies (ATI) at weeks 6, 22 and 30. ResultsDemographic and baseline data of the study population are presented in Table 1.Among the 62 patients enrolled, 33.9% of patients (n = 21/62) were in remission at week 30. Eight patients dropped out due to disease worsening. Median TLs at week 6 were higher among patients in clinical remission at week 30 (p = 0.02) confirming previous observations. However, ILs at day 3 as well as PLs after the third infusion were also significantly higher in patients in clinical remission at week 30 (Figure 1a–c).ATI were detected as soon as week 6. At week 2, infliximab levels were significantly lower among patients in which ATI developed at a later time point (p = 0.006) and this observation was confirmed when measuring ILs at day 17 (p = 0.002), TLs at week 6 (p = 0.002) and ILs at week 10 (p = 0.001). ConclusionThis multicentre prospective study demonstrates that intermediate levels as early as day 3 predict remission at week 30 in IBD patients. Low IFX levels during induction were correlated to future ATI development. PK modelling may allow to better select patients early on for sustained remission with infliximab.

    更新日期:2020-01-17
  • P667 Combined therapy of perianal fistulas with autologous adipose-derived stem cells
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Surowiecka A, Łodyga M, Durlik M, et al.

    BackgroundAutologous adipose-derived stem cells (ADSCs) are pluripotent medical stimulatory cells. In damaged tissues, they activate regeneration by secretion of various growth factors, anti-inflammatory cytokines and migration factors. Autologous ADSCs are harvested from subcutaneous fat tissue. MethodsThe aim of our study was to create a protocol of combined surgical and biologic treatment of perianal fistulas followed with transfer of autologous ADSCs into fistulas. It was a prospective study. We selected patients diagnosed with Crohn’s disease with perianal fistulas, confirmed in MRI or transanal US, with no symptoms of abscess formation. In this protocol, we started from fistulas setoning. Afterwards, two courses of biologic agents were conducted. In the next step, autologous ADSCs were harvested from subcutaneous fat tissue and transferred to inactive fistulas. We used Arthrex®system to acquire ADSCs. Further courses with biologic agents followed the ADSCs transfer. To evaluate the outcomes we used Pikarky’s Perianal Crohn’s Disease Activity Index. A good resolution was defined as fistula closure, incomplete healing as partial resolution without complete closure and fistula reactivation as no resolution. ResultsIn a preliminary study we collected data of 10 patients. The mean volume of lipoaspirate was 30 ml. The mean amount of ADSCs transferred was 4 ml. The mean operative time was 90 min. The early observation time varied from 1 to 3 months. In all cases, these were bifurcated complex and trans-sphincteric fistulas. There were no cases of no resolution. Early results were promising with almost all cases of good resolution. However, longer observation is required. ConclusionAutologous adipose-derived stem cells in combination with surgical setoning and biological agents are a good alternative for patients with perianal manifestation of Crohn’s disease.

    更新日期:2020-01-17
  • P768 Long-term prognosis of Crohn’s disease and its temporal changes between 1986 and 2015 in a population-based cohort in the Songpa-Kangdong district of Seoul, Korea
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Ye B, , Park H, et al.

    BackgroundNo previous population-based study has evaluated the natural course of Crohn’s disease (CD) over three decades in non-Caucasians. We previously reported a 30-year trend in the epidemiology of inflammatory bowel disease (IBD) in the Songpa-Kangdong (SK) District of Seoul, Korea between 1986 and 2015 (1). In this study, we aimed to analyse the long-term natural course of Korean patients with CD in the SK-IBD population-based cohort. MethodsAll patients newly diagnosed with CD between 1986 and 2015 were enrolled in this study. To assess the temporal trends in treatment paradigms and in the prognosis of CD, patients were divided into two cohorts according to the year of CD diagnosis: cohort 1, 1986–2003 and cohort 2, 2004–2015 (the anti-tumour necrosis factor [anti-TNF] era). Disease characteristics at diagnosis, outcomes and their predictors were evaluated. ResultsA total of 418 patients were enrolled. There were 318 males (76.1%) and median age at CD diagnosis was 22 years (interquartile range [IQR], 18–29). Disease location at CD diagnosis was ileal in 104 patients (24.9%), colonic in 39 (9.3%), and ileocolonic in 275 (65.8%). Disease behaviour at CD diagnosis was inflammatory in 339 patients (81.1%), stricturing in 34 (8.1%), and penetrating in 45 (10.8%). Perianal fistula/abscess was present in 43.3% (n = 181) before or at CD diagnosis. During the median follow-up of 108.1 months, the overall use of systemic corticosteroids, thiopurines, and anti-TNF agents was 57.4%, 80.9%, and 34.2%, respectively. Compared with the cohort 1, the cumulative probability of commencing corticosteroids decreased (p = 0.001), whereas that of commencing thiopurines and anti-TNF agents increased (both p < 0.001) in the cohort 2. A total of 113 patients (27.0%) underwent intestinal resection, demonstrating cumulative risks of intestinal resection at 1, 5, 10, 20, and 25 years after diagnosis of 12.5%, 16.5%, 25.6%, 49.7%, and 55.5%, respectively. Multivariate Cox regression analysis revealed that stricturing behaviour at diagnosis (hazard ratio [HR] 2.393, 95% confidence interval [CI] 1.234–4.641), penetrating behaviour at diagnosis (HR 4.514, 95% CI 1.752–11.629), and the cohort 2 (HR 0.530, 95% CI 0.297–0.945) were independent predictors of intestinal resection. The standardised mortality ratio was 1.867 (95% confidence interval, 0.502–4.780). ConclusionKorean patients showed a similar clinical course and intestinal resection rate compared with Western patients. The risk of intestinal resection has decreased in the anti-TNF era. Reference Park SH, Kim YJ, Rhee KH, et al. A 30-year Trend Analysis in the Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District of Seoul, Korea in 1986–2015. J Crohns Colitis 2019;13(11):1410–1417.

    更新日期:2020-01-17
  • P161 Intra-abdominal abscess in Crohn’s disease
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    SAIR A, Lagdali N, Ben El Barhdadi I, et al.

    BackgroundCrohn’s disease (CD) is associated with the emergence of complications, including intra-abdominal abscess. Management is multidisciplinary based on close medical-surgical collaboration. The aim of the study was to evaluate the clinical characteristics, the efficacy of different therapeutic options of intra-abdominal abscess in CD patients and to identify predictive factors of a favorable response. MethodsMedical records of 56 CD patients who had intra-abdominal abscess were retrospectively reviewed. Patients with postoperative abscess were excluded. Clinical, biological and therapeutic data were retrospectively assessed. Treatment progression was appreciated.IBM SPSS software 21.0 was used for statistical analysis of our data. ResultsIn total, 897 patients were identified as having CD in the study period, 56 of them developed intra-abdominal abscess. Means that the prevalence of intra-abdominal abscess in CD patients was 6,2%.Mean age was 35,24 ± 11,6 years old with a sex ratio M/F 0,64. 47,3% had penetrating CD. 50.9% of our patients were known to be carriers of Crohn’s disease, 45% of whom were on 5-ASA, while the remaining patients 49.1% (n = 26), the abscess was inaugural and revealing of the CD.The clinical signs were dominated by pain in 80%, the abscess was localised mainly at the right iliac fossa in 77.7% of cases. Median size of collection was 3,8 ± 2 cm. There were 47,3% patients who had fistula associated to abscess. The initial reactive C protein ranged from 14 to 320 (median 58.3) mg/L.All patients had first-line treatment based on broad-spectrum bi-antibiotic therapy, alone in 25.5%, combined with surgical resection in 45.5%, surgical abscess drainage without resection in 23,6% or guided by imaging in 5.5%, the initial success was 71.7%. 28.3% of patients underwent surgery for initial treatment failure, which was dominated by ileocecal resection in 53.1%. Overall success was 92.3%, only one death was noted following postoperative release with peritonitis. Predictive factor of favorable response was: fistula associated with intra-abdominal abscess (p =0.03) and surgical resection seems to be the best therapeutic option (p < 0,001). ConclusionIntra-abdominal abscess is a complication of Crohn’s disease (CD) mainly penetrating, in almost half of the cases, it can reveal CD. Our study showed that the presence of fistula appears to be significantly associated with therapeutic success and the best results are obtained in the case of surgical resection.

    更新日期:2020-01-17
  • N21 Self-management and healthcare utilisation of 16–21 year olds with inflammatory bowel disease (IBD) attending one Irish hospital
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Forry M, Milewska M, Lardner C, et al.

    BackgroundIBD is an umbrella term used to describe Crohn’s disease and ulcerative colitis, both characterised as lifelong relapsing remitting diseases (O’Connor et al., 2013). Hope et al (2012) reported a significant increase in the incidence of childhood IBD in Ireland over a relatively short period of time.The aim of this research study was to assess the self-management and healthcare utilisation skills of adolescents and young adults (AYA) (aged 16–21 years) with (IBD). MethodsService users aged from 16 to 21 attending the IBD service were asked to complete the Transition Readiness Assessment Questionnaire (TRAQ). Divided into five domains, 20 questions related to: managing medications, appointment keeping, tracking health issues, talking with providers and managing daily activities. Results31 completed questionnaires were returned via stamped addressed envelope provided. Seventeen patients were diagnosed in a paediatric hospital and 14 were diagnosed in adult hospital services. Seventy-five per cent of respondents manage their own medications, 50% take responsibility for appointment keeping and 51% keep track of their health issues. Eighty-nine per cent talk to health care providers independently and 81% manage daily activities independently. Further analysis showed that females had significantly higher health tracking scores compared with males p = 0.04. Overall, 65% of all female users provided positive feedback regarding this domain. In male group this score reached only 40%. The biggest discrepancy was noted in relation to query concerning the list of questions before doctor`s visit. Almost 70% of females replied positively to this question, while only 28% of male patients provided positive answer. There was no significant difference in scores from those diagnosed in paediatric setting vs. those diagnosed in adult hospital services. ConclusionSome aspects of the appointment keeping as well as health tracking issues (especially in male group) were identified as domains that need further improvement. Ongoing education will be provided to patients attending the service with training focused on increasing awareness of the users in the most lacking domains.

    更新日期:2020-01-17
  • P464 Vedolizumab concentrations in colonic mucosal tissue of ulcerative colitis patients inversely correlate with the severity of inflammation
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Van den Berghe N, Verstockt B, Gils A, et al.

    BackgroundMultiple studies have reported the association between vedolizumab serum concentrations and endoscopic outcomes in patients with ulcerative colitis (UC). However, little is known about drug consumption in tissue and the relationship with mucosal inflammation. This study aimed to investigate vedolizumab concentrations in the tissue of UC patients and the correlation with their inflammatory state and serum levels. MethodsA paired serum sample and colonic mucosal biopsy were collected in 36 UC patients at week 14 of vedolizumab treatment. In non-responders, defined as a Mayo endoscopic subscore of ≥2, inflamed colonic biopsies were taken in the sigmoid around 20–30 cm from the anal verge. In responders, defined as a Mayo endoscopic subscore ≤ 1, a biopsy was taken in a macroscopically uninflamed area at the same location. Biopsies were lysed by the addition of 10 μl lysis buffer (50 mM Tris, 0.1% Triton X-100 and 100 mM NaCl) per mg tissue and vortexed every 5 min during 1 h. Total protein content was measured and normalised to 3 mg/ml before analysis of the vedolizumab concentration using an in-house developed ELISA. Results are expressed as µg vedolizumab/mg total protein content. ResultsA positive correlation was observed between vedolizumab concentrations in tissue and serum (Spearman r = 0.8447, p < 0.0001), both in inflamed (r = 0.8609, p <0.0001, n = 16) and uninflamed tissue (r = 0.7925, p <0.0001, n = 20). The median tissue vedolizumab concentration in patients with Mayo endoscopic subscore 0, 1, 2 and 3 were 0.120, 0.074, 0.062 and 0.064 μg/mg, respectively (p < 0.01, see figure), indicating that tissue drug levels inversely correlate with the severity of inflammation. Vedolizumab tissue concentrations were significantly lower in non-responders compared with responders (0.064 vs. 0.112 μg/mg, p <0.05). Moreover, patients achieving Mayo endoscopic subscore 0 had significantly higher vedolizumab levels in colonic tissue compared with patients not achieving this outcome (0.120 vs. 0.065 μg/mg, p <0.02). Interestingly, a trend was observed towards higher serum-to-tissue ratios of vedolizumab in non-responders compared with responders (p = 0.0523). This finding suggests that if two patients have the same serum vedolizumab concentration, the patient with mucosal inflammation is more likely to have lower tissue levels than the patient with no or limited inflammation. ConclusionVedolizumab concentrations in colonic mucosal tissue of UC patients inversely correlate with the severity of inflammation. As the serum-to-tissue ratio of vedolizumab is numerically higher in non-responders compared with responders, the relative distribution of vedolizumab in serum and tissue might be more important than the drug concentration alone.

    更新日期:2020-01-17
  • OP07 The epidemiology of inflammatory bowel diseases among immigrants to Denmark: A population-based cohort study
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Agrawal M, Shrestha S, Corn G, et al.

    BackgroundThe incidence of inflammatory bowel diseases (IBDs) among immigrants and in countries with historically low IBD risk is rising, implicating environmental risk factors in IBD pathogenesis. The purpose of our study was to determine the incidence rates of Crohn’s disease (CD) and ulcerative colitis (UC), among immigrants to Denmark, a high IBD incidence country, according to the country of birth and age at immigration, in comparison with the corresponding incidence rates in the Danish host population. MethodsUsing the Danish Civil Registration System, we identified all residents in Denmark with a known country of birth between January 1977 and December 2018. First-generation immigrants were persons who, along with parents, were born outside Denmark; second-generation immigrants were Danish-born persons whose parents were born outside Denmark. We recorded immigrants’ (or parents’) country of birth, age at immigration and duration of stay in Denmark. Study participants were followed for CD and UC diagnosis in the Danish National Patient Registry. Incidence rate ratios (IRRs) according to immigration status were estimated using log-linear Poisson regression analysis, and stratified by IBD prevalence in the country of birth (low, intermediate and high), and among first-generation immigrants, by age at immigration and duration of stay in Denmark. ResultsIn this cohort of 9,038,025 subjects, among 1,295,518 first-generation and 208,826 second-generation immigrants eligible for inclusion, 4,805 first-generation and 898 second-generation immigrants were diagnosed with CD or UC. The risk of IBD among first-generation immigrants reflected risk in the country of birth (low, intermediate or high, Table 1), and increased with >20 years stay in Denmark (Table 2). Among second-generation immigrants, the risk of CD and UC was comparable to that in Danish natives (Table 1). Younger age at immigration did not impact IBD risk. ConclusionIn this population-based study, the risk of IBD among first-generation immigrants reflected that in their country of birth, and increased with >20 years stay in Denmark. Among second-generation immigrants, the risk was comparable to native Danes. These findings underscore the role of environmental risk factors in the aetiology of IBD. Further studies to determine risk factors for IBD among immigrants to Denmark are ongoing.

    更新日期:2020-01-17
  • P363 Moderate endurance and muscle training are safe to perform for patients with quiescent or mild active Crohn’s disease and increases their strength
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Seeger W, Thieringer J, Esters P, et al.

    BackgroundThe aim of this study was to examine the practicability and potential influence of moderate endurance and muscle training in patients with quiescent or mildly active Crohn’s disease (CD). MethodsIn this randomised controlled pilot trial 45 CD Patients with a CDAI below 220 were randomised to a control, an endurance or a muscle training group. Participants had to exercise individually for 3 months three times per week. Outcome parameters included disease activity (CDAI), inflammatory parameters and calprotectin, anthropometric data, general well-being (sIBDQ), physical activity (IPAQ), cardiorespiratory fitness as well as strength in the upper and lower extremities. ResultsForty-five patients were randomised into an endurance (17), muscle (15) and control (13) group, respectively. In the endurance group, the dropout rate was 47% (8) vs. 13% (2) in the muscle group and 0 in the control group. Only one patient discontinued the study due to CD specific symptoms. One patient had to stop the study due to another concomitant disease. One patient in each intervention group was lost to follow-up. The most frequent reason for termination was lack of time and motivation: 37.5% (3) in the endurance group vs. 50% (1) in the muscle group. In both groups, the maximal and average force in the upper and lower extremity increased significantly (all p < 0.04). A statistically significant improvement of the quality of life could only be seen in the endurance group in the subclass ‘mood’ of the sIBDQ (p = 0.03). CDAI decreased in the muscle group in contrast to both other groups, statistical significance, however, was not reached. ConclusionThis study shows that both endurance and muscle training can be safely performed in patients with mild-to-moderate CD. Muscle training seems to be more feasible for this patient group. Both forms of exercise have beneficial effects on strength and presumably on comorbidities, e.g. bone mineral density and thromboembolic complications. Further research in a larger population and also patients with higher disease activity is needed to examine the effects of moderate exercise on disease activity and immunological changes in CD patients.

    更新日期:2020-01-17
  • P260 Adaptation of TECCU App based on patients’ perceptions for telemonitoring inflammatory bowel disease: A qualitative study using focus groups
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Del Hoyo Francisco J, Nos P, Faubel R, et al.

    BackgroundDespite the continuous adaptation of eHealth systems for patients with inflammatory bowel disease (IBD), a significant disconnection persists between users and developers. Since non-adherence remains high, it is necessary to better understand the patients’ perspectives on telemonitoring for IBD. The aim of this study was to adapt the TECCU app to the preferences and needs of IBD patients. MethodsA qualitative study was carried out using successive focus groups of IBD patients. Meetings were audio-recorded and a thematic analysis approach was employed until data saturation was achieved. The first group included patients who had used the TECCU app in a pilot clinical trial, and subsequent meetings included patients with Crohn’s disease and ulcerative colitis recruited from the Spanish Confederation of patient associations. The information collected at each meeting guided consecutive changes to the platform. ResultsData saturation was reached after 3 focus groups, involving a total of 18 patients. Three main themes emerged: (1) platform usability; (2) the communication process; and (3) contents of the platform. All participants indicated that TECCU is easy to use, permitting continuous and personalised feedback. Nevertheless, the platform was adapted according to the patients′ perspectives to foster a flexible follow-up and shared decision-making, using open and safe communication networks. Many participants appreciated the educational elements and the app was connected to reliable and continuously updated webpages. ConclusionIBD patients valued the usability and personalised monitoring offered by the TECCU App. Improvements in the messaging system and continuous updates of the educational contents were performed to address patients′ needs and favour their engagement.

    更新日期:2020-01-17
  • P058 The lived experience of family planning of female patients diagnosed with inflammatory bowel disease and their partners during key reproductive stages: a qualitative study
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Czuber-Dochan W, Homer R, Brookes M, et al.

    BackgroundInflammatory bowel disease (IBD) is a chronic illness affecting patients in their childbearing years. The physical effects of IBD on fertility and pregnancy in IBD in remission (e.g. disease is well controlled during conception and throughout pregnancy) are similar to the normal population. However, many women with IBD have high pregnancy-related anxieties and are more likely not to have children compared with women without IBD. The reasons cited for not having children include high levels of pregnancy-related anxieties have been insufficiently explored. The study aimed to explore the lived experience of family planning of women with inflammatory bowel disease (IBD) and their partners with or without IBD, during the reproductive stages of pre-conception, pregnancy and the postnatal period. MethodsDescriptive phenomenology was used to conduct face-to-face in-depth individual interviews. Purposive sampling was used to select participants with a maximum variation of different demographic and clinical factors, e.g. age, sex, UC/CD diagnosis, disease duration, surgery and geographic location. The NVivo 12 software programme was used to manage the data and Colaizzi’s framework was utilised in thematic data analysis. ResultsTwenty-four participants (21 women 11CD/10UC and three partners) were recruited from out-patient clinics (22 participants) or through the Crohn’s and Colitis UK website (two participants). Women, average age 31 years old (range 27–38), were at different family planning stages: pre-conception six women (three actively planning family and three voluntarily childless); pregnant eight women and two partners; and postpartum seven women and one partner. Three women’s partners, age 32–39, were recruited allowing for additional perspective of the experience being captured. In total, 19 h of interviews data were collected. Six themes were identified: (1) being diagnosed and controlling IBD symptoms, (2) relationship and family planning, (3) sources of information, (4) worries and concerns about pregnancy, (5) post pregnancy care and problems and (6) ways of improving care. Women in pre-pregnancy stage and pregnant expressed a need for more information around these themes: (1) their medication and the impact of IBD on the baby, (2) the genetic risk of passing the disease on. While pregnant and during post-partum stage, women identified a greater need for practical advice and support in relation to breastfeeding and looking after the baby. ConclusionInformation specific to family planning stages need to be provided, to help women and their partners make the informed decision about family planning. Those who decided not to go down the family route also expressed a need for counselling and support.

    更新日期:2020-01-17
  • P769 Prevalence and duration of gastrointestinal symptoms in the 10 years before diagnosis of inflammatory bowel disease: A national cohort study
    J. Crohns Colitis (IF 7.827) Pub Date : 2020-01-15
    Blackwell J, , Saxena S, et al.

    BackgroundGastrointestinal (GI) symptoms of Inflammatory Bowel Disease (IBD) may go undiagnosed resulting in diagnostic delay.Aims: To determine the frequency and duration of GI symptoms in the decade before the diagnosis of Crohn’s Disease (CD) and ulcerative colitis (UC) and risk factors for delayed specialist review. MethodsWe used the Clinical Practice Research Datalink, a nationally representative research database, to identify incident cases of CD and UC diagnosed from 1998 to 2016. Comparison cohorts without IBD were matched 4:1 for age and sex and assigned the IBD diagnosis date of their matched IBD patient as a pseudo-diagnosis date. We compared the prevalence of GI symptoms between the IBD and comparison cohorts in the 10 years before IBD diagnosis. We identified individuals with chronic GI symptoms lasting more than 6 weeks and measured their time to receiving a specialist review with a gastroenterologist, paediatric gastroenterologist or colorectal surgeon. We identified risk factors for receiving specialist review after presenting with chronic GI symptoms. ResultsWe identified 5874 incident cases of CD, 13,681 incident cases of UC and comparison cohorts of 78,114 individuals. 10% of the CD and UC cohorts reported GI symptoms to their primary care physician 5 years before diagnosis.Fewer than 50% of patients were reviewed by a specialist within 18 months of presenting to their primary care physician with chronic GI symptoms. Patients with a previous diagnosis of Irritable Bowel Syndrome (IBS) or depression were less likely to receive timely specialist review (IBS: HR 0.77, 95%CI 0.60–0.99, depression: HR 0.77, 95%CI 0.60–0.98). ConclusionA substantial number of individuals experience GI symptoms many years before receiving a diagnosis of IBD. IBS and depression are risk factors for delayed specialist review. Rapid diagnostic pathways should be established to reduce the burden of diagnostic delay in IBD.

    更新日期:2020-01-17
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