Background

Vedolizumab (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.

Methods

A 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.

Results

The 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)

Conclusion

A 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.

中文翻译：

---

P664维多珠单抗对炎性肠病患者肠外表现的影响：单中心队列的真实生活经验

背景

Vedolizumab（VDZ）是一种肠道特异性抗整合素，已被批准用于治疗中度至重度克罗恩病（CD）和溃疡性结肠炎（UC）。肠外表现（EIM）通常与炎症性肠病（IBD）相关。但是，VDZ对EIM的影响仍然未知。当前研究的目的是描述VDZ开始时IBD患者中EIM的患病率，持续治疗期间的进展以及新EIM的发生。

方法

对2010年5月至2019年2月在VDZ上开始治疗的IBD患者进行了单中心研究。回顾性地，在基线，术后6个月和1年时，评估了医生报告的EIM和肠道疾病活动（临床和内镜）。 VDZ的启动。

结果

该队列包括134例患者，包括77例CD患者，56例UC患者和1例未分类IBD的患者。在VDZ开始时，对127名患者进行了EIM评估，其中17.3％的EIM≥1：肝EIM 9例（中毒性肝炎2例，自身免疫性肝炎2例，PSC 5例），关节病7例（轴向脊椎关节病6例，外周关节炎1例） ），3个进一步指定的轴向或周围关节痛和3个皮肤EIM（荨麻疹，牛皮癣和结节性红斑）。表1报道了EIM的临床演变，表2评估了肠道疾病的活动。在随访期间，发现了23种新的EIM，主要是关节痛，通常是短暂的。由于32位患者的活动性肠道疾病，患者的选择（n = 1）或深部疾病缓解（n = 1），在39/130（30％）患者中停止了VDZ。6周（n = 121）： 26（21.5）≥1 EIM 6个月（n = 113）： 26（23％）≥1 EIM 1年（n = 104）： 17（16.3％）≥1 EIM n（％）稳定更糟的新总改进稳定更糟的新总稳定更糟的新总Arthropathy4（66.7）02（33.3）6 2（25）5（62.5）01（12.5）8 8（100）00 8 Arthralgia3（30）1（10） 6（60）10 1（10）5（50）04（40）10 4（100）00 4皮肤EIM01（25）3（75）4 1（33.3）002（66.7）3 001（100）1肝EIM5（100）00 5 005（83.3）1（16.7）6 5（100）00 5肌痛002（100）2 01（50）01（50）2 1（50）1（50）0 2表2.临床，n（％）6个月（n = 109）1年（n = 106）无反应13（11.9）10（9.4）反应34（31.2）24（22.6）缓解62（56.9）72（67.9）内窥镜检查，n（％）入职后（n = 81）1年（n = 44）无回应24（29.6）12（27.3）回应35（43.2）7（15.9）缓解22（27.2）25（56.8）

结论

观察到良好的临床肠道反应。但是，在我们的队列研究中，EIM的临床演变似乎不受VDZ的使用影响。需要前瞻性数据来确认这些结果。