Impact of Concomitant 5-Aminosalicylic Acid Therapy on Vedolizumab Efficacy and Safety in Inflammatory Bowel Disease: Post Hoc Analyses of Clinical Trial Data.

IF 8.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Journal of Crohns & Colitis Pub Date : 2023-12-30 DOI:10.1093/ecco-jcc/jjad113
Ryan C Ungaro, Harisha Kadali, Wenwen Zhang, Shashi Adsul, Walter Reinisch
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Abstract

Background and aims: The benefit of continuing 5-aminosalicylic acid [5-ASA] treatment when escalating to advanced therapies in patients with inflammatory bowel disease [IBD] is unclear. Vedolizumab is a gut-selective monoclonal anti-α4β7-integrin antibody used to treat moderate to severe IBD. Clinical trial data were analysed post hoc to assess the impact of 5-ASA co-treatment on vedolizumab efficacy and safety in patients with IBD.

Methods: Data were analysed from patients aged 18-80 years with moderate to severe ulcerative colitis [UC]/Crohn's disease [CD] receiving intravenous [IV]/subcutaneous [SC] vedolizumab. Efficacy data were from four studies [GEMINI 1 and 2 and VISIBLE 1 and 2]; safety data were from seven studies [GEMINI 1‒3 and long-term, VISIBLE 1, 2, and open-label extension]. The impact of 5-ASA co-treatment on clinical and endoscopic outcomes at Weeks 6 and 52 was assessed using multivariate analysis (adjusted odds ratios [aORs] with 95% confidence intervals [CIs]).

Results: There were no significant differences in UC clinical remission [Mayo score ≤2, no subscore >1] rates with vs without 5-ASA at Week 6 [20.7% vs 20.4%, respectively; aOR 0.77, 95% CI 0.43-1.38] or at Week 52 [45.1% vs 40.6%; aOR 1.14, 0.70-1.86], and in CD clinical remission [CD activity index score ≤150] rates at Week 6 [41.4% vs 35.1%; 1.26, 0.86-1.85] or at Week 52 [49.6% vs 37.8%; 1.35, 0.91-1.99]. The incidence of enteric and all infections in vedolizumab IV/SC-treated patients was low with and without 5-ASA.

Conclusion: Continuation of concomitant oral 5-ASA after starting vedolizumab had no significant impact on clinical and endoscopic outcomes.

Clinical trial identifiers: GEMINI 1: NCT00783718, EudraCT 2008-002782-32; GEMINI 2: NCT00783692, EudraCT 2008-00278-33; GEMINI 3: NCT01224171, EudraCT 2009-016488-12; GEMINI long-term safety study: NCT00790933, EudraCT 2008-002784-14; VISIBLE 1: NCT02611830, EudraCT 2015-000480-14; VISIBLE 2: NCT02611817, EudraCT 2015-000481-58; VISIBLE open-label extension: NCT02620046, EudraCT 2015-000482-31.

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炎症性肠病患者同时接受 5-氨基水杨酸治疗对维多珠单抗疗效和安全性的影响:临床试验数据的事后分析。
背景和目的:炎症性肠病[IBD]患者在升级到晚期疗法时继续接受5-氨基水杨酸[5-ASA]治疗的益处尚不明确。维多珠单抗是一种肠道选择性单克隆抗α4β7整合素抗体,用于治疗中度至重度IBD。我们对临床试验数据进行了事后分析,以评估5-ASA联合治疗对维多珠单抗在IBD患者中疗效和安全性的影响:分析了18-80岁中重度溃疡性结肠炎[UC]/克罗恩病[CD]患者接受静脉注射[IV]/皮下注射[SC]维多珠单抗治疗的数据。疗效数据来自四项研究[GEMINI 1和2以及VISIBLE 1和2];安全性数据来自七项研究[GEMINI 1-3和长期研究、VISIBLE 1、2以及开放标签扩展研究]。采用多变量分析(调整后的几率比[aORs],95%置信区间[CIs])评估了5-ASA联合治疗对第6周和第52周的临床和内镜结果的影响:第 6 周时,使用 5-ASA 与不使用 5-ASA 的 UC 临床缓解率[梅奥评分≤2,无子项评分>1]无明显差异[分别为 20.7% vs 20.4%;aOR 0.77,95% CI 0.43-1.38],第 52 周时也无明显差异[45.1% vs 40.6%;aOR 0.77,95% CI 0.43-1.38]。1%对40.6%;aOR 1.14,0.70-1.86],以及第6周[41.4%对35.1%;1.26,0.86-1.85]或第52周[49.6%对37.8%;1.35,0.91-1.99]的CD临床缓解率[CD活动指数评分≤150]。在使用和不使用5-ASA的情况下,维多珠单抗IV/SC治疗患者的肠道感染和所有感染的发生率都很低:结论:开始使用维多珠单抗后继续同时口服5-ASA对临床和内镜结果没有显著影响:GEMINI 1:NCT00783718,EudraCT 2008-002782-32;GEMINI 2:NCT00783692,EudraCT 2008-00278-33;GEMINI 3:NCT01224171,EudraCT 2009-016488-12;GEMINI长期安全性研究:NCT00790933,EudraCT 2008-002784-14;VISIBLE 1:NCT02611830, EudraCT 2015-000480-14;VISIBLE 2:NCT02611817, EudraCT 2015-000481-58;VISIBLE 开放标签扩展:NCT02620046,EudraCT 2015-000482-31。
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来源期刊
Journal of Crohns & Colitis
Journal of Crohns & Colitis 医学-胃肠肝病学
CiteScore
15.50
自引率
7.50%
发文量
1048
审稿时长
1 months
期刊介绍: Journal of Crohns and Colitis is concerned with the dissemination of knowledge on clinical, basic science and innovative methods related to inflammatory bowel diseases. The journal publishes original articles, review papers, editorials, leading articles, viewpoints, case reports, innovative methods and letters to the editor.
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