Gastroenterology Institute, Sheba Medical Center, Tel HaShomer, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Gastrounit, Medical Division, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.
Inflamm Bowel Dis. 2023 Nov 2;29(11):1713-1722. doi: 10.1093/ibd/izad075.
Patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, may develop extraintestinal manifestations (EIMs). The EMOTIVE study aimed to analyze the effect of vedolizumab on EIMs in a real-world cohort of patients with IBD.
This multicenter, descriptive, retrospective study was conducted in Belgium, Denmark, Israel, the Netherlands, and Switzerland in adults with moderately to severely active IBD and concurrent active EIMs at vedolizumab initiation (index date), with a ≥6-month follow-up after the index date. The primary endpoint was resolution of all EIMs within 6 months of vedolizumab initiation.
In 99 eligible patients, the most frequent EIMs were arthralgia (69.7%), peripheral spondyloarthritis (21.2%), and axial spondyloarthritis (10.1%). Within 6 and 12 months of vedolizumab initiation, 19.2% and 25.3% of patients reported resolution of all EIMs, while 36.5% and 49.5% of all EIMs were reported to be improved (combination of resolution and partial response), respectively. Vedolizumab treatment persistence at 12 months was 82.8%. Adverse events were reported in 18.2% of patients, with the most frequent being arthralgia (4.0%).
This real-world study showed resolution of all EIMs in up to one-fourth of patients with IBD and improvement in up to half of EIMs within 12 months of vedolizumab treatment. Overall, vedolizumab was effective on EIMs in patients with IBD and showed a good safety profile.
炎症性肠病(IBD)患者,包括克罗恩病和溃疡性结肠炎,可能会出现肠外表现(EIMs)。EMOTIVE 研究旨在分析Vedolizumab 在 IBD 患者真实世界队列中对 EIMs 的影响。
本多中心、描述性、回顾性研究在比利时、丹麦、以色列、荷兰和瑞士进行,纳入在 Vedolizumab 起始时(索引日期)同时存在活动 EIMs 且中重度活动 IBD 的成年患者,在索引日期后至少有 6 个月的随访。主要终点是在 Vedolizumab 起始后 6 个月内所有 EIMs 的缓解。
在 99 例符合条件的患者中,最常见的 EIMs 是关节炎(69.7%)、外周脊柱关节炎(21.2%)和中轴脊柱关节炎(10.1%)。在 Vedolizumab 起始后 6 个月和 12 个月时,19.2%和 25.3%的患者报告所有 EIMs 缓解,而 36.5%和 49.5%的所有 EIMs 得到改善(缓解和部分缓解的组合)。12 个月时,Vedolizumab 治疗的持续率为 82.8%。18.2%的患者报告发生了不良事件,最常见的是关节炎(4.0%)。
这项真实世界研究显示,在接受 Vedolizumab 治疗 12 个月内,高达四分之一的 IBD 患者的所有 EIMs 得到缓解,高达一半的 EIMs 得到改善。总体而言,Vedolizumab 对 IBD 患者的 EIMs 有效,且具有良好的安全性。