治疗中重度斑块型银屑病的生物制剂：系统综述和网络荟萃分析

IF 3.5 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-07-01 Epub Date: 2025-05-06 DOI:10.1007/s13555-025-01423-0

Mark G Lebwohl, André Carvalho, Akihiko Asahina, Jianzhong Zhang, Mir Sohail Fazeli, Ellen Kasireddy, Paul Serafini, Thomas Ferro, Ranga Gogineni, Diamant Thaçi

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引用次数: 0

摘要

简介：中重度斑块型银屑病是一种影响生活质量的慢性疾病。该网络荟萃分析（NMA）比较了所有被批准用于治疗中重度斑块性银屑病的生物制剂的疗效和安全性，以更好地告知供应商中期结果，重点关注白细胞介素- 23p19抑制剂tildrakizumab。方法：检索MEDLINE®、Embase和CENTRAL从成立到2024年1月的随机临床试验（RCT）。比较生物制剂与安慰剂或其他报告牛皮癣面积和严重程度指数（PASI）、医师总体评估（PGA） 0/1或皮肤病生活质量指数（DLQI） 0/1反应和安全结局（不良事件[ae]或严重ae [sae]）的随机对照试验。在第28周作为主要兴趣时间点进行贝叶斯nma。在第12周和第16周也进行了分析。结果用风险比(RR；疗效结局)、风险差异(RD；安全性结局)和需要治疗的人数（NNT），可信区间为95%。结果：在筛选的7418篇文献中，187篇文献描述了12种生物制剂的124项随机对照试验被纳入系统文献综述，103项随机对照试验被纳入NMA。在第28周，与安慰剂相比，所有治疗均显示出改善的疗效和生活质量。第28周，Tildrakizumab对PASI 75 （RR 8.74 vs. 8.92和8.91）、PASI 90 （RR 14.09 vs. 14.81和14.77）和PGA 0/1 （RR 9.34 vs. 10.29和10.23）的疗效分别与risankizumab和guselkumab相当。与安慰剂相比，没有生物制剂显示出更高的SAEs风险；与安慰剂相比，tildrakizumab对ae的风险没有增加。结论：在第28周，与安慰剂相比，所研究的生物制剂显示出更高的疗效和生活质量，到第16周，与安慰剂相比，SAEs的风险没有增加。在第28周，tildrakizumab、risankizumab和guselkumab的疗效相当。局限性包括12周或16周后缺乏安慰剂比较物，这可能影响结果。

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Biologics for the Treatment of Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Network Meta-analysis.

Introduction: Moderate-to-severe plaque psoriasis is a chronic disease impacting quality of life (QoL). This network meta-analysis (NMA) compared efficacy and safety of all biologics approved for the treatment of moderate-to-severe plaque psoriasis to better inform providers on mid-term outcomes, with a focus on the interleukin-23 p19 inhibitor tildrakizumab.

Methods: MEDLINE®, Embase, and CENTRAL were searched for randomized clinical trials (RCT) from inception through January 2024. RCTs comparing biologics against placebo or each other reporting Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA) 0/1, or Dermatology Life Quality Index (DLQI) 0/1 responses and safety outcomes (adverse events [AEs] or serious AEs [SAEs]) were sought. Bayesian NMAs were performed at week 28 as the primary time point of interest. Analyses were also performed at weeks 12 and 16. Findings were expressed as risk ratios (RR; efficacy outcomes), risk differences (RD; safety outcomes), and numbers needed to treat (NNT) with 95% credible intervals.

Results: Of 7418 publications screened, 187 describing 124 RCTs of 12 biologics were included in the systematic literature review, and 103 RCTs were included for NMA. All treatments demonstrated improved efficacy and QoL vs. placebo at week 28. Tildrakizumab efficacy at week 28 was comparable to risankizumab and guselkumab, respectively, for PASI 75 (RR 8.74 vs. 8.92 and 8.91), PASI 90 (RR 14.09 vs. 14.81 and 14.77), and PGA 0/1 (RR 9.34 vs. 10.29 and 10.23). No biologics exhibited an increased risk of SAEs vs. placebo; tildrakizumab exhibited no increased risk vs. placebo for AEs.

Conclusions: The investigated biologics demonstrated improved efficacy and QoL relative to placebo at week 28, with no increased risk of SAEs vs. placebo through week 16. At week 28, efficacy of tildrakizumab, risankizumab, and guselkumab was comparable. Limitations include lack of placebo comparators after week 12 or 16, which could affect results.

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.