5-氨基水杨酸联合治疗对炎症性肠病患者维得利珠单抗疗效和安全性的影响：临床试验数据的事后分析。
Impact of Concomitant 5-Aminosalicylic Acid Therapy on Vedolizumab Efficacy and Safety in Inflammatory Bowel Disease: Post Hoc Analyses of Clinical Trial Data.
机构信息
The Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Takeda, Global Patient Safety and Evaluation, Cambridge, MA, USA.
出版信息
J Crohns Colitis. 2023 Dec 30;17(12):1949-1961. doi: 10.1093/ecco-jcc/jjad113.
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.
背景和目的
在炎症性肠病（IBD）患者中升级为高级治疗时继续使用 5-氨基水杨酸（5-ASA）治疗的益处尚不清楚。Vedolizumab 是一种用于治疗中重度 IBD 的肠道选择性单克隆抗-α4β7-整联蛋白抗体。对临床试验数据进行了事后分析，以评估 5-ASA 联合治疗对 IBD 患者 vedolizumab 疗效和安全性的影响。
方法
分析了年龄在 18-80 岁的中度至重度溃疡性结肠炎（UC）/克罗恩病（CD）患者的静脉（IV）/皮下（SC）vedolizumab 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、VISIBLE 1、2 和开放标签扩展）。使用多变量分析（调整后的优势比[ORs]和 95%置信区间[CIs]）评估第 6 周和第 52 周时 5-ASA 联合治疗对临床和内镜结局的影响。
结果
第 6 周时，与无 5-ASA 组相比，有 5-ASA 组 UC 临床缓解（Mayo 评分≤2，无任何评分>1）率无显著差异[分别为 20.7%和 20.4%；调整 OR 0.77，95%CI 0.43-1.38]或第 52 周时[分别为 45.1%和 40.6%；调整 OR 1.14，95%CI 0.70-1.86]，CD 临床缓解（CD 活动指数评分≤150）率也无显著差异，第 6 周时[分别为 41.4%和 35.1%；调整 OR 1.26，95%CI 0.86-1.85]或第 52 周时[分别为 49.6%和 37.8%；调整 OR 1.35，95%CI 0.91-1.99]。vedolizumab IV/SC 治疗患者的肠道和所有感染的发生率均较低，无论是否联合使用 5-ASA。
结论
在开始使用 vedolizumab 后继续口服联合使用 5-ASA 对临床和内镜结局没有显著影响。
临床试验标识符
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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