Effectiveness and Safety of Vedolizumab Induction Therapy for Patients With Inflammatory Bowel Disease
Effectiveness and Safety of Vedolizumab Induction Therapy for Patients With Inflammatory Bowel Disease
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DOI：
10.1016/j.cgh.2016.02.016
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发表时间：
2016-11-01
影响因子：
12.6
通讯作者：
Bouhnik, Yoram
中科院分区：
文献类型：
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作者：
Amiot, Aurelien;Grimaud, Jean-Charles;Bouhnik, Yoram
背景与目的：III期试验显示了Vedolizumab（与整合素α 4 β 7结合）在克罗恩病（CD）或溃疡性结肠炎（UC）患者中的疗效。我们研究了Vedolizumab在抗肿瘤坏死因子治疗失败的患者中的有效性和安全性。方法：从2014年6月至12月，有173例CD患者和121例UC患者被纳入法国监管机构批准的多中心提名同情抢先体验计划。该计划为患者提供了在批准上市之前获得vedolizumab的机会。Vedolizumab（300 mg）在第0、2和6周静脉给药，然后每8周一次。使用Harvey-Bradshaw指数（CD）和部分马约临床评分（UC）评估疾病活动性。我们报告了14周诱导期后获得的结果。结果：在294名接受vedolizumab治疗的患者中平均年龄39.5 ± 14.0岁，平均病程10.8 ± 7.6岁，伴随使用类固醇，44%的病例），276例完成诱导期，但是，18例因缺乏应答而停用Vedolizumab（n = 14），输注相关反应（n = 2）或感染（n = 2）。第14周时，31%的CD患者处于无类固醇临床缓解，51%有应答;在UC患者中，36%处于无类固醇临床缓解，50%有应答。未报告死亡。24例患者发生严重不良事件（8.2%），其中15（5.1%）导致Vedolizumab停药（1例肺结核和1例直肠腺癌）结论：在既往抗肿瘤坏死因子治疗失败的CD或UC患者队列中，约三分之一的患者在Vedolizumab诱导治疗14周后达到无类固醇临床缓解。该药物在这些患者中具有可接受的安全性特征。
BACKGROUND & AIMS: Phase 3 trials have shown the efficacy of vedolizumab, which binds to integrin alpha 4 beta 7, in patients with Crohn's disease (CD) or ulcerative colitis (UC). We investigated the effectiveness and safety of vedolizumab in patients who failed anti-tumor necrosis factor therapy.METHODS: From June through December 2014, there were 173 patients with CD and 121 patients with UC who were included in a multicenter nominative compassionate early access program granted by French regulatory agencies. This program provided patients with access to vedolizumab before it was authorized for marketing. Vedolizumab (300 mg) was administered intravenously at weeks 0, 2, and 6, and then every 8 weeks. Disease activity was assessed using the Harvey-Bradshaw Index for CD and the partial Mayo Clinic score for UC. We report results obtained after the 14-week induction phase.RESULTS: Among the 294 patients treated with vedolizumab (mean age, 39.5 +/- 14.0 y; mean disease duration, 10.8 +/- 7.6 y; concomitant steroids, 44% of cases), 276 completed the induction period, however, 18 discontinued vedolizumab because of a lack of response (n = 14), infusion-related reaction (n = 2), or infections (n = 2). At week 14, 31% of patients with CD were in steroid-free clinical remission and 51% had a response; among patients with UC, 36% were in steroid-free clinical remission and 50% had a response. No deaths were reported. Severe adverse events occurred in 24 patients (8.2%), including 15 (5.1%) that led to vedolizumab discontinuation (1 case of pulmonary tuberculosis and 1 rectal adenocarcinoma).CONCLUSIONS: In a cohort of patients with CD or UC who failed previous anti-tumor necrosis factor therapy, approximately one third of patients achieved steroid-free clinical remission after 14 weeks of induction therapy with vedolizumab. This agent had an acceptable safety profile in these patients.