Barberio Brigida, Gracie David J, Black Christopher J, Ford Alexander C
Department of Surgery, Oncology and Gastroenterology, University of Padua, Padova, Italy.
Leeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Gut. 2023 Feb;72(2):264-274. doi: 10.1136/gutjnl-2022-328052. Epub 2022 Jul 30.
There are numerous biological therapies and small molecules licensed for luminal Crohn's disease (CD), but these are often studied in placebo-controlled trials, meaning relative efficacy is uncertain. We examined this in a network meta-analysis.
We searched the literature to 1 July 2022, judging efficacy according to induction of clinical remission, clinical response and maintenance of clinical remission, and according to previous exposure or non-exposure to biologics. We used a random effects model and reported data as pooled relative risks (RRs) with 95% CIs, ranking drugs according to p-score.
We identified 25 induction of remission trials (8720 patients). Based on failure to achieve clinical remission, infliximab 5 mg/kg ranked first versus placebo (RR=0.67, 95% CI 0.56 to 0.79, p-score 0.95), with risankizumab 600 mg second and upadacitinib 45 mg once daily third. However, risankizumab 600 mg ranked first for clinical remission in biologic-naïve (RR=0.66, 95% CI 0.52 to 0.85, p-score 0.78) and in biologic-exposed patients (RR=0.74, 95% CI 0.67 to 0.82, p-score 0.92). In 15 maintenance of remission trials (4016 patients), based on relapse of disease activity, upadacitinib 30 mg once daily ranked first (RR=0.61, 95% CI 0.52 to 0.72, p-score 0.93) with adalimumab 40 mg weekly second, and infliximab 10 mg/kg 8-weekly third. Adalimumab 40 mg weekly ranked first in biologic-naïve patients (RR=0.59, 95% CI 0.48 to 0.73, p-score 0.86), and vedolizumab 108 mg 2-weekly first in biologic-exposed (RR=0.70, 95% CI 0.57 to 0.86, p-score 0.82).
In a network meta-analysis, infliximab 5 mg/kg ranked first for induction of clinical remission in all patients with luminal CD, but risankizumab 600 mg was first in biologic-naïve and biologic-exposed patients. Upadacitinib 30 mg once daily ranked first for maintenance of remission.
有多种生物疗法和小分子药物被批准用于治疗腔内型克罗恩病（CD），但这些药物通常是在安慰剂对照试验中进行研究的，这意味着其相对疗效尚不确定。我们通过网络荟萃分析对此进行了研究。
我们检索了截至2022年7月1日的文献，根据临床缓解的诱导、临床反应和临床缓解的维持情况，以及既往是否接触过生物制剂来判断疗效。我们使用随机效应模型，并将数据报告为合并相对风险（RRs）及95%置信区间（CIs），根据p值对药物进行排序。
我们纳入了25项缓解诱导试验（8720例患者）。基于未实现临床缓解的情况，英夫利昔单抗5mg/kg与安慰剂相比排名第一（RR = 0.67，95%CI 0.56至0.79，p值0.95），瑞莎珠单抗600mg排名第二，乌帕替尼45mg每日一次排名第三。然而，瑞莎珠单抗600mg在未接触过生物制剂的患者（RR = 0.66，95%CI 0.52至0.85，p值0.78）和接触过生物制剂的患者中（RR = 0.74，95%CI 0.67至0.82，p值0.92）临床缓解方面排名第一。在15项缓解维持试验（4016例患者）中，基于疾病活动复发情况，乌帕替尼30mg每日一次排名第一（RR = 0.61，95%CI 0.52至0.
