Department of Gastroenterology, The First People's Hospital of Shangqiu City, Xinxiang Medical University, Shangqiu, Henan Province, China.
Department of Gastroenterology, Shanghai Tenth People's Hospital, Tongji University, Shanghai, China.
J Dig Dis. 2021 Jul;22(7):408-418. doi: 10.1111/1751-2980.13026. Epub 2021 Jun 29.
To compare the efficacy and safety of a combination therapy of biologics and immunosuppressants with biological monotherapy in inflammatory bowel disease (IBD) in a systematic review and meta-analysis.
Eligible randomized controlled trials (RCTs) on the comparison of the efficacy and safety of biologics and immunomodulators with biological monotherapy were identified from the EMBASE, PubMed and the Cochrane Library databases published up to 1 May 2020. Raw data were extracted, pooled relative risk (RR) and 95% confidence interval (CI) was calculated, the fixed-effect and inverse variance models were used. Funnel plots were performed to analyze publication bias.
Twelve RCTs were eligible for analysis. Overall, there was statistically a benefit for combination treatment over biologic monotherapy (IFX/ADA) in inducing clinical remission and preventing relapse in patients with IBD (RR 0.89, 95% CI 0.80-0.98). Moreover, the combination therapy was superior to biological monotherapy for active CD (RR 0.83, 95% CI 0.73-0.94). Also, there were significant benefits for combination therapy in the subgroup treated with infliximab (IFX) (RR 0.83, 95% CI 0.70-0.97).
Combination therapy has slight benefits in inducing clinical remission in active CD compared with biological monotherapy. Patients with IBD who receive therapy with IFX and immunomodulator also have a mild advantage in comparison with those treated with IFX monotherapy.
系统评价和荟萃分析比较生物制剂和免疫抑制剂联合治疗与生物单药治疗炎症性肠病(IBD)的疗效和安全性。
从 EMBASE、PubMed 和 Cochrane Library 数据库中检索到比较生物制剂和免疫调节剂与生物单药治疗疗效和安全性的合格随机对照试验(RCT),截至 2020 年 5 月 1 日。提取原始数据,计算合并相对风险(RR)和 95%置信区间(CI),使用固定效应和逆方差模型。绘制漏斗图分析发表偏倚。
共有 12 项 RCT 符合分析条件。总体而言,联合治疗在诱导 IBD 患者临床缓解和预防复发方面优于生物单药治疗(IFX/ADA;RR 0.89,95%CI 0.80-0.98)。此外,联合治疗在活动期 CD 患者中优于生物单药治疗(RR 0.83,95%CI 0.73-0.94)。对于接受英夫利昔单抗(IFX)治疗的亚组,联合治疗也具有显著优势(RR 0.83,95%CI 0.70-0.97)。
与生物单药治疗相比,联合治疗在诱导活动期 CD 临床缓解方面略有优势。接受 IFX 和免疫调节剂治疗的 IBD 患者与接受 IFX 单药治疗的患者相比也有轻度优势。