Barberio Brigida, Gracie David J, Black Christopher J, Ford Alexander C
Department of Surgery, Oncology and Gastroenterology (DISCOG), Gastroenterology Unit, University of Padova-Azienda Ospedaliera di Padova, Padova, Italy.
Leeds Gastroenterology Institute, St. James's University Hospital, Leeds, UK.
Aliment Pharmacol Ther. 2025 Jul;62(1):4-21. doi: 10.1111/apt.70209. Epub 2025 May 23.
Numerous biologics and small molecules are licensed as maintenance therapy for ulcerative colitis (UC). Differences in the design of randomised controlled trials (RCTs) have not been considered when comparing efficacy between them.
To examine the relative efficacy of biologics and small molecules by network meta-analysis according to trial design.
We searched the literature to 27 February 2025 for RCTs. We judged efficacy using clinical remission, endoscopic improvement, endoscopic remission, or corticosteroid-free remission and according to previous exposure or non-exposure to advanced therapies. Random effects model with data reported as pooled relative risks (RR) with 95% confidence intervals (CI); drugs ranked by p-score.
We identified 28 RCTs, 16 re-randomising 6568 patients and 12 treating through 3771 patients. In re-randomised studies, upadacitinib 30 mg o.d. ranked first for clinical remission (RR of failure to achieve clinical remission = 0.52; 95% CI 0.44-0.61, p-score 0.99) and endoscopic improvement (RR = 0.43; 95% CI 0.35-0.52, p-score 0.99). Vedolizumab 300 mg 4-weekly ranked first for endoscopic remission (RR = 0.73; 95% CI 0.64-0.84, p-score 0.92) and guselkumab 200 mg 4-weekly first for corticosteroid-free remission (RR = 0.40; 95% CI 0.28-0.55, p-score 0.95). In treat-through studies, etrasimod 2 mg o.d. ranked first for clinical remission (RR = 0.73; 95% CI 0.64-0.83, p-score 0.88) and infliximab 10 mg/kg 8-weekly first for endoscopic improvement (RR = 0.64; 95% CI 0.56-0.74, p-score 0.94).
In network meta-analysis, upadacitinib and etrasimod were consistently efficacious as maintenance therapy in UC.
许多生物制剂和小分子药物已被批准用于溃疡性结肠炎（UC）的维持治疗。在比较它们的疗效时，尚未考虑随机对照试验（RCT）设计的差异。
根据试验设计，通过网络荟萃分析来检验生物制剂和小分子药物的相对疗效。
我们检索了截至2025年2月27日的文献中的随机对照试验。我们使用临床缓解、内镜改善、内镜缓解或无皮质类固醇缓解，并根据先前是否接触过先进疗法来判断疗效。采用随机效应模型，数据以合并相对风险（RR）及95%置信区间（CI）报告；药物按p值评分排序。
我们确定了28项随机对照试验，其中16项重新随机分组了6568名患者，12项治疗了3771名患者。在重新随机分组的研究中，乌帕替尼30mg每日一次在临床缓解方面排名第一（未实现临床缓解的RR = 0.52；95% CI 0.44 - 0.61，p值评分0.99），在内镜改善方面排名第一（RR = 0.43；95% CI 0.35 - 0.52，p值评分(0.99)）。维得利珠单抗300mg每4周一次在内镜缓解方面排名第一（RR = 0.73；95% CI (0.64 - 0.84)，p值评分0.92），古塞库单抗200mg每4周一次在无皮质类固醇缓解方面排名第一（RR = 0.40；95% CI (0.28 - 0.55)，p值评分0.95）。在持续治疗研究中，艾曲莫德2mg每日一次在临床缓解方面排名第一（RR = 0.73；95% CI (0.64 - 0.83)，p值评分0.88），英夫利昔单抗10mg/kg每8周一次在内镜改善方面排名第一（RR = 0.64；95% CI (0.56 - 0.74)，p值评分0.94）。
在网络荟萃分析中，乌帕替尼和艾曲莫德作为UC的维持治疗始终有效。
