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比较皮下注射和静脉注射英夫利昔单抗与维得利珠单抗治疗 TNF 初治成人炎症性肠病患者的维持治疗效果:系统文献回顾和网络荟萃分析。

Comparative Efficacy of Subcutaneous and Intravenous Infliximab and Vedolizumab for Maintenance Treatment of TNF-naive Adult Patients with Inflammatory Bowel Disease: A Systematic Literature Review and Network Meta-analysis.

机构信息

Department of Gastroenterology, Centre Hospitalier Régional Universitaire de Nancy, Nancy, France.

Imelda GI Clinical Research Centre, Imelda General Hospital, Bonheiden, Belgium.

出版信息

Dig Dis Sci. 2024 May;69(5):1808-1825. doi: 10.1007/s10620-023-08252-1. Epub 2024 Mar 18.

Abstract

BACKGROUND

Infliximab and vedolizumab are widely used to treat Crohn's disease (CD) and ulcerative colitis (UC).

AIMS

This systematic review and network meta-analysis evaluated comparative efficacy of various regimens for intravenous or subcutaneous infliximab and vedolizumab during maintenance treatment in CD and UC.

METHODS

Parallel-group randomized controlled trials (RCTs) were identified by a systematic literature review (CRD42022383401) and included if they evaluated therapeutics of interest for maintenance treatment of adults with moderate-to-severe luminal CD or UC and assessed clinical remission between Weeks 30 and 60. Clinical remission rates in CD or UC and mucosal healing rates in UC were analyzed in a Bayesian network meta-analysis model. Endoscopic outcomes in CD were synthesized by proportional meta-analysis.

RESULTS

Overall, 13 RCTs were included in the analyses. All vedolizumab studies randomized induction responders to maintenance treatment; infliximab studies used a treat-through design. Subcutaneous infliximab 120 mg every 2 weeks had the highest odds ratio (OR) [95% credible interval] versus placebo for clinical remission during the maintenance phase (CD: 5.90 [1.90-18.2]; UC: 5.45 [1.94-15.3]), with surface under the cumulative ranking curve (SUCRA) values of 0.91 and 0.82, respectively. For mucosal healing in UC, subcutaneous infliximab 120 mg every 2 weeks showed the highest OR (4.90 [1.63-14.1]), with SUCRA value of 0.73, followed by intravenous vedolizumab 300 mg every 4 weeks (SUCRA value, 0.70). Endoscopic outcomes in CD were better with subcutaneous infliximab 120 mg every 2 weeks than intravenous infliximab 5 mg/kg every 8 weeks.

CONCLUSIONS

Subcutaneous infliximab showed a favorable efficacy profile for achieving clinical remission and endoscopic outcomes during maintenance treatment in CD or UC.

摘要

背景

英夫利昔单抗和维得利珠单抗广泛用于治疗克罗恩病(CD)和溃疡性结肠炎(UC)。

目的

本系统评价和网络荟萃分析评估了静脉或皮下使用英夫利昔单抗和维得利珠单抗在 CD 和 UC 维持治疗中的各种方案的比较疗效。

方法

通过系统文献回顾(CRD42022383401)确定平行组随机对照试验(RCT),并纳入评估成人中重度腔型 CD 或 UC 维持治疗中治疗药物的 RCT,评估 30 至 60 周时的临床缓解率。采用贝叶斯网络荟萃分析模型分析 CD 或 UC 的临床缓解率和 UC 的黏膜愈合率。CD 的内镜结局通过比例荟萃分析进行综合。

结果

总体而言,13 项 RCT 纳入分析。所有维得利珠单抗研究均将诱导缓解者随机分配至维持治疗;英夫利昔单抗研究采用治疗贯穿设计。与安慰剂相比,皮下注射英夫利昔单抗 120mg,每 2 周 1 次,在维持期的临床缓解率最高(CD:5.90[1.90-18.2];UC:5.45[1.94-15.3]),累积排序曲线下面积(SUCRA)值分别为 0.91 和 0.82。对于 UC 的黏膜愈合,皮下注射英夫利昔单抗 120mg,每 2 周 1 次的 OR 最高(4.90[1.63-14.1]),SUCRA 值为 0.73,其次是静脉注射维得利珠单抗 300mg,每 4 周 1 次(SUCRA 值,0.70)。与静脉注射英夫利昔单抗 5mg/kg,每 8 周 1 次相比,皮下注射英夫利昔单抗 120mg,每 2 周 1 次的内镜结局更好。

结论

在 CD 或 UC 的维持治疗中,皮下注射英夫利昔单抗在实现临床缓解和内镜结局方面具有良好的疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f1ed/11098872/e6602c0d840c/10620_2023_8252_Fig1_HTML.jpg

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