Department of Gastroenterology, São João University Hospital Center, Porto, Portugal.
Clinical Pharmacology Unit, São João University Hospital Center, Porto, Portugal.
United European Gastroenterol J. 2023 Mar;11(2):202-217. doi: 10.1002/ueg2.12366. Epub 2023 Mar 6.
The availability of biological agents for inflammatory bowel disease has increased over the past years. In this systematic review and meta-analysis, we aimed to explore time trends in clinical response and clinical remission rates in Crohn's disease (CD) patients treated with biologics while discussing the need for new strategies.
MEDLINE, Cochrane, and ISI Web of Science databases were searched for randomized placebo-controlled trials with biological agents in moderate-to-severe CD patients. Sub-group and meta-regression analyses compared treatment and placebo by calculating the pooled odds ratios of clinical remission and clinical response, across time categories and publication year. We also estimated the proportion of patients achieving clinical remission and clinical response by comparing both groups according to the publication year.
Twenty-five trials were included in the systematic review, which enrolled 8879 patients between 1997 and 2022. The clinical remission and clinical response odds, in induction and maintenance, have been constant over time, as no statistically significant differences were found between time categories (interaction p-values: clinical remission [induction, p = 0.19; maintenance, p = 0.24]; clinical response [induction, p = 0.43; maintenance, p = 0.59]). In meta-regression analyses, publication year did not influence these outcomes (clinical remission [induction, OR 1.01{95% CI 0.97-1.05}, p = 0.72; clinical response [induction, OR 1.01{95% CI 0.97-1.04]; p = 0.63; maintenance, OR 1.03{95% CI 0.98-1.07}; p = 0.21]), with the exception of clinical remission in maintenance studies, which presented a decreased effect (odds ratio 0.97{95% CI 0.94-1.00}, p = 0.03]).
Our review highlights that the odds of clinical outcomes in CD patients receiving biological treatment relative to placebo have been stable in the last decades.
近年来，用于炎症性肠病的生物制剂的可用性有所增加。在这项系统评价和荟萃分析中，我们旨在探讨接受生物制剂治疗的克罗恩病（CD）患者的临床缓解率和临床应答率的时间趋势，并讨论新策略的必要性。
我们在 MEDLINE、Cochrane 和 ISI Web of Science 数据库中搜索了关于中度至重度 CD 患者使用生物制剂的随机安慰剂对照试验。通过计算临床缓解和临床应答的汇总优势比，我们在时间类别和出版年份上比较了治疗组和安慰剂组。我们还根据出版年份比较了两组患者的临床缓解率和临床应答率，以估计达到临床缓解和临床应答的患者比例。
本系统评价共纳入 25 项试验，共纳入 1997 年至 2022 年期间的 8879 名患者。诱导和维持治疗的临床缓解和临床应答优势在时间上没有变化，因为在时间类别之间没有发现统计学上的显著差异（交互 p 值：临床缓解[诱导，p=0.19；维持，p=0.24]；临床应答[诱导，p=0.43；维持，p=0.59]）。在荟萃回归分析中，出版年份并未影响这些结果（临床缓解[诱导，OR 1.01{95% CI 0.97-1.05}，p=0.72；临床应答[诱导，OR 1.01{95% CI 0.97-1.04}，p=0.63；维持，OR 1.03{95% CI 0.98-1.07}，p=0.21]），除了维持研究中的临床缓解外，其效果降低（比值比 0.97{95% CI 0.94-1.00}，p=0.03）。
我们的综述强调，在过去几十年中，接受生物治疗的 CD 患者的临床结局的优势比相对安慰剂保持稳定。
