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.
J Crohns Colitis. 2023 Dec 30;17(12):1949-1961. doi: 10.1093/ecco-jcc/jjad113.
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.
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]).
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.
Continuation of concomitant oral 5-ASA after starting vedolizumab had no significant impact on clinical and endoscopic outcomes.
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.
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。
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。
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。
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。
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。
