米利珠单抗与目前获批的治疗溃疡性结肠炎的生物药物的疗效和安全性比较:系统综述和网络荟萃分析。

IF 2.9 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Pharmacotherapy Pub Date : 2024-10-01 Epub Date: 2024-09-25 DOI:10.1002/phar.4611
Paweł Moćko, Magdalena Koperny, Katarzyna Śladowska, Przemysław Holko, Iwona Kowalska-Bobko, Paweł Kawalec
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引用次数: 0

摘要

溃疡性结肠炎(UC)是一个严重的健康问题,需要不断寻找新的有效药物。本研究旨在评估米利珠单抗与其他获批用于治疗中度至重度活动性 UC 的生物药物相比的疗效和安全性。这项采用频谱网络荟萃分析(NMA)的系统性综述纳入了评估阿达木单抗、戈利木单抗、英夫利昔单抗、米利珠单抗、维妥珠单抗和乌司替珠单抗与安慰剂或另一种获批生物药的使用情况的随机对照试验(RCT)。NMA 使用 netmeta R 软件包进行。P评分用于确定治疗的排序。共有 14 项研究纳入分析。在临床反应和缓解发生率方面,米利珠单抗与其他药物之间未发现明显差异。在临床应答方面,米利珠单抗优于安慰剂(诱导:几率比[OR] = 2.38;95% 置信区间[CI]:1.63-3.48;维持:1.63-3.48):1.63-3.48;维持治疗:OR=3.31,95%置信区间:1.59-6.89)和缓解(诱导:或 = 2.09,95% 置信区间 [CI]:1.20-3.63;维持:或 = 2.96;95% 置信区间 [CI]:1.59-6.89OR=2.96;95% CI:1.62-5.40)。概率图显示,就临床反应和缓解而言,英夫利西单抗可能是诱导期最有效的选择(P 值分别为 0.8971 和 0.8814)。在诱导期的任何不良事件(AEs)、严重不良事件(SAEs)和感染方面,以及在维持期的任何不良事件、感染和严重感染方面,研究药物之间无明显差异。两种药物在因AE(诱导和维持阶段)以及SAE和严重感染(维持阶段)而停药方面存在差异。在UC患者的诱导和维持阶段,米利珠单抗在临床反应和缓解方面与其他生物制剂没有差异。在诱导阶段,米利珠单抗的临床反应排名为第3位,临床缓解排名为第5位。因此,它是一种有价值的治疗选择。在AEs和SAEs风险方面没有明显差异,这表明米利珠单抗与其他药物具有相似的安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and safety of mirikizumab compared with currently approved biologic drugs for the treatment of ulcerative colitis: A systematic review and network meta-analysis.

Ulcerative colitis (UC) is a serious health problem that requires a constant need to identify new effective drugs. The aim of this study was to assess the efficacy and safety of mirikizumab compared with other biologic drugs approved for the treatment of moderately to severely active UC. This systematic review with frequentist network meta-analysis (NMA) included randomized controlled trials (RCTs) that evaluated the use of adalimumab, golimumab, infliximab, mirikizumab, vedolizumab, and ustekinumab compared with placebo or with another approved biologic drug. The NMA was conducted using the netmeta R software package. The P score was used to determine the treatment ranking. A total of 14 RCTs were included in the analysis. No significant differences were observed in the incidence of clinical response and remission between mirikizumab and other drugs. Mirikizumab was superior to placebo for clinical response (induction: odds ratio [OR] = 2.38; 95% confidence interval [CI]: 1.63-3.48; maintenance: OR = 3.31, 95% CI: 1.59-6.89) and remission (induction: OR = 2.09, 95% CI: 1.20-3.63; maintenance: OR = 2.96; 95% CI: 1.62-5.40). The probability plot indicated that infliximab might be the most effective option in terms of both clinical response and remission (P score, 0.8971 and 0.8814, respectively) in induction phase. No significant differences were noted between the studied drugs in any adverse events (AEs), serious AEs (SAEs) and infections for the induction phase, and in any AEs, infections and serious infections for the maintenance phase. The drugs differed in terms of discontinuation due to AEs (induction and maintenance phases) as well as SAEs and serious infections (maintenance phase). Mirikizumab did not differ from other biologics in terms of clinical response and remission for both induction and maintenance phases in patients with UC. Mirikizumab during the induction phases achieved rank 3 for clinical response and rank 5 for clinical remission. Therefore, it represents a valuable treatment option. The lack of significant differences in the risk of AEs and SAEs suggests that mirikizumab has a similar safety profile to the other drugs.

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来源期刊
Pharmacotherapy
Pharmacotherapy 医学-药学
CiteScore
7.80
自引率
2.40%
发文量
93
审稿时长
4-8 weeks
期刊介绍: Pharmacotherapy is devoted to publication of original research articles on all aspects of human pharmacology and review articles on drugs and drug therapy. The Editors and Editorial Board invite original research reports on pharmacokinetic, bioavailability, and drug interaction studies, clinical trials, investigations of specific pharmacological properties of drugs, and related topics.
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