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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
Journal of Crohn's and Colitis ( IF 8 ) Pub Date : 2020-01-15 , DOI: 10.1093/ecco-jcc/jjz203.489
S Mazza 1 , A Fascì 1 , V Casini 2 , C Ricci 3 , F Munari 3 , L Pirola 4 , C Girelli 5 , G Lupinacci 6 , L Pastorelli 7 , F Cavallaro 7 , N Piazza O’Sed 7 , L Ferraris 8 , A Colucci 8 , A Amato 9 , V Maurizio 1, 10 , G Fiorino 11 , F Caprioli 1, 10
Affiliation  

Background
Since 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.
Methods
This 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.
Results
Fifty-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.
Conclusion
The 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.


中文翻译:

P360对发炎性肠病(SCESICS)患者从英夫利昔单抗双重转换至生物仿制药CT-P13和SB2的安全性和临床疗效:一项多中心研究

背景
自2015年英夫利昔单抗(IFX)专利到期以来,几种IFX生物仿制药已在欧盟获得许可用于所有适应症,包括炎症性肠病(IBD)。目前在意大利可获得的IFX生物仿制药包括CT-P13和SB2,它们在IBD患者中均具有与IFX起始者相当的疗效,安全性和免疫原性。从前瞻性IFX到CT-P13的单次转换的安全性和临床疗效也已在一项前瞻性临床试验中得到证实。相反,目前缺乏有关IFX始发者使用CT-P13和SB2进行多种治疗性转换的数据。
方法
这项研究旨在评估IBD患者从IFX发起者到CT-P13再到SB2双重转换的安全性和有效性。从2018年11月至2019年5月,对在伦巴第8个中心接受IFX双重转换的患者进行回顾性分析。记录IFX停药的总发生率,不良事件的发生率和类型(AE)以及随着时间推移临床缓解的患者比例。将数据与从IFX始发者切换为CT-P13的66名IBD患者的对照组进行比较。
结果
纳入52例双转换IBD患者(63%M,平均年龄41岁,75%克罗恩氏病,25%溃疡性结肠炎)。IFX治疗的主要适应症是中重度疾病(50%)和类固醇依赖性疾病(25%)。进行第二次转换后(CTP13-> SB2),整个24周和48周IFX停药率分别为2%(95%CI 0–6%)和14%(95%CI 3-25%)。在40周的中位随访(18-48)中,有4例(12%)经历了6次AE(2例皮肤,2例传染性,1例关节和1例免疫学),导致3例IFX中断(6 %)。没有观察到输液反应。在第二次转换后的第24周,有49名(94%)患者处于临床缓解期,其余3例患者在第二次转换时尚未缓解。第24周后,只有一名患者失去反应,随访结束时有48名(92%)患者处于临床缓解期。双转换和单转换患者之间IFX停药,不良事件和临床缓解率无差异。未发现可预测安全性和疗效结果的临床参数。
结论
这项研究支持IBD患者从IFX始发者到CT-P13和SB2双重转换的安全性和有效性,并证明了其不劣于单一转换策略,并可能带来成本影响。
更新日期:2020-01-17
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