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葡萄牙治疗溃疡性结肠炎患者的生物制剂和小分子药物的比较疗效和安全性:系统文献回顾和网络荟萃分析。

The comparative efficacy and safety of biologics and small molecules for treating patients with ulcerative colitis in Portugal: a systematic literature review and network meta-analysis.

机构信息

Global Health Economics & Outcomes Research, AbbVie, Inc., Boulevard, Mettawa, IL, USA.

出版信息

Eur Rev Med Pharmacol Sci. 2023 Jul;27(14):6744-6759. doi: 10.26355/eurrev_202307_33145.

Abstract

OBJECTIVE

The use of biological drugs to treat ulcerative colitis (UC) represents a clear added value; nevertheless, many patients do not have a sustained response to these drugs. Small molecules were recently approved for the treatment of UC in Portugal. This network meta-analysis aimed to compare the efficacy and safety of the different therapies, including biological and small molecules, in patients prior exposed to biological treatment.

MATERIALS AND METHODS

A systematic review of the literature was performed on January 6, 2022, identifying all the relevant reports about the efficacy and safety of biologics (adalimumab, golimumab, infliximab, vedolizumab, ustekinumab) and small molecules (upadacitinib, filgotinib, tofacitinib) in the treatment of UC in Portugal. Network meta-analysis (NMA) was conducted using Bayesian Markov Chain Monte Carlo simulations. Results were presented in median Odds Ratio and Surface Under the Cumulative RAnking (SUCRA) score for each treatment.

RESULTS

Treatment of UC is divided into two phases: induction and maintenance. Upadacitinib 45 mg was the most efficacious therapy in achieving clinical remission and response and endoscopic improvement in the induction phase. Concerning the maintenance phase, upadacitinib 30 mg performed better than ustekinumab formulations in clinical remission and response, and endoscopic improvement. Regarding safety, there were no significant differences between all the drugs included in the analysis.

CONCLUSIONS

This network meta-analysis showed that upadacitinib reflects better efficacy compared to the available treatments for bio-exposed patients with moderate to severe UC. The safety profile is comparable to the other drugs.

摘要

目的

生物药物治疗溃疡性结肠炎(UC)具有明显的附加价值;然而,许多患者对这些药物没有持续的反应。小分子药物最近在葡萄牙被批准用于治疗 UC。本网络荟萃分析旨在比较包括生物制剂和小分子药物在内的不同治疗方法在先前接受生物治疗的患者中的疗效和安全性。

材料和方法

2022 年 1 月 6 日进行了文献系统评价,确定了所有关于生物制剂(阿达木单抗、戈利木单抗、英夫利昔单抗、维得利珠单抗、乌司奴单抗)和小分子药物(乌帕替尼、菲戈替尼、托法替布)在葡萄牙治疗 UC 的疗效和安全性的相关报告。使用贝叶斯马尔可夫链蒙特卡罗模拟进行网络荟萃分析(NMA)。结果以每种治疗方法的中位数优势比和累积排序曲线下面积(SUCRA)评分呈现。

结果

UC 的治疗分为诱导期和维持期。在诱导期,45mg 乌帕替尼在实现临床缓解、应答和内镜改善方面是最有效的治疗方法。关于维持期,30mg 乌帕替尼在临床缓解、应答和内镜改善方面优于乌司奴单抗制剂。关于安全性,在分析中包括的所有药物之间没有显著差异。

结论

本网络荟萃分析表明,与生物制剂暴露患者中用于治疗中度至重度 UC 的现有治疗方法相比,乌帕替尼具有更好的疗效。安全性与其他药物相当。

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