Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan.
Center for Preventive Medicine, Keio University School of Medicine, Tokyo, Japan.
J Gastroenterol Hepatol. 2021 Jul;36(7):1744-1753. doi: 10.1111/jgh.15401. Epub 2021 Feb 3.
Ustekinumab (UST), a fully humanized monoclonal antibody against the p40 subunit of interleukin-12/23, is effective for the treatment of Crohn's disease (CD). The benefit of concomitant use of an immunomodulator (IM) with UST, however, is unclear. This study aimed to provide a systematic review and meta-analysis comparing the efficacy and safety of concomitant use of an IM with UST as an induction therapy for CD patients.
A systematic literature search was performed using PubMed/MEDLINE, the Cochrane Library, and the Japana Centra Revuo Medicina from inception to October 31, 2019. The main outcome measure was achievement of clinical efficacy (remission, response, and clinical benefit) at 6-12 weeks. The quality of the included studies was assessed using the risk of bias in non-randomized studies of interventions (ROBINS-I) tools. The fixed-effects model was used to calculate the pooled odds ratios.
From 189 yielded articles, six including a total of 1507 patients were considered in this meta-analysis. Concomitant use of an IM with UST was significantly effective than UST monotherapy as an induction therapy (pooled odds ratio in the fixed-effects model: 1.35, 95% confidence interval [1.06-1.71], P = 0.015). The heterogeneity among studies was low (I = 2.6%). No statistical comparisons of the occurrence of adverse events between UST monotherapy and concomitant use of an IM with UST were performed.
The efficacy of concomitant use of an IM with UST as an induction therapy for CD was significantly superior to that of monotherapy with UST.
乌司奴单抗（UST）是一种针对白细胞介素-12/23 的 p40 亚单位的全人源化单克隆抗体，对治疗克罗恩病（CD）有效。然而，联合使用免疫调节剂（IM）与 UST 的益处尚不清楚。本研究旨在提供一项系统评价和荟萃分析，比较联合使用 IM 与 UST 作为 CD 患者诱导治疗的疗效和安全性。
从建库至 2019 年 10 月 31 日，通过 PubMed/MEDLINE、Cochrane 图书馆和 Japana Centra Revuo Medicina 进行系统文献检索。主要结局指标为 6-12 周时达到临床疗效（缓解、应答和临床获益）。使用非随机干预研究的偏倚风险（ROBINS-I）工具评估纳入研究的质量。使用固定效应模型计算汇总优势比。
从 189 篇生成的文章中，有 6 篇共纳入 1507 例患者纳入荟萃分析。与 UST 单药治疗相比，联合使用 IM 作为诱导治疗明显更有效（固定效应模型汇总优势比：1.35，95%置信区间[1.06-1.71]，P=0.015）。研究间异质性较低（I²=2.6%）。未对 UST 单药治疗和联合使用 IM 的不良事件发生情况进行统计学比较。
联合使用 IM 与 UST 作为 CD 诱导治疗的疗效明显优于 UST 单药治疗。
