Efficacy and Safety of Medical Interventions for Moderate to Severe Hidradenitis Suppurativa: A Living Systematic Review and Network Meta-Analysis.

IF 11.5 1区 医学 Q1 DERMATOLOGY
Amit Garg, Erica Cohn, Bria Midgette, Kelly Frasier, Andrew Strunk
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引用次数: 0

Abstract

Importance: There is limited comparative information on regulatory approved and pipeline treatments in hidradenitis suppurativa (HS).

Objective: To compare efficacy, safety, and tolerability of treatments for moderate to severe HS.

Data sources: MEDLINE, Embase, ClinicalTrials.gov, and Cochrane Central Register of Controlled Trials were searched from inception to June 28, 2024.

Study selection: Phase 2 and 3 randomized clinical trials of medical interventions (cytokine inhibitors, small molecule inhibitors, cell inhibitors, and other novel immune or inflammatory modifiers) for adults with moderate to severe HS having primary efficacy assessments between 12 and 16 weeks.

Data extraction and synthesis: Data extraction and risk of bias assessments were performed independently by 2 reviewers. Efficacy outcomes were analyzed using random-effects network meta-analysis. Safety and tolerability outcomes were analyzed using pairwise fixed-effect meta-analyses vs placebo. Data analysis was performed between August 22, 2024, and April 7, 2025.

Main outcomes and measures: Primary efficacy, safety, and tolerability outcomes were Hidradenitis Suppurativa Clinical Response (HiSCR)-50, occurrence of serious adverse events (SAEs), and treatment discontinuation due to adverse events, respectively. HiSCR-75 was a secondary efficacy outcome.

Results: Of 26 eligible trials, 25 had available HiSCR-50 data, including 5767 total patients and 39 unique treatments. Compared with placebo, the following treatments were associated with significantly higher HiSCR-50 response rates: sonelokimab, 120 mg, every 4 weeks; lutikizumab, 300 mg, every 2 weeks; adalimumab, 40 mg, once per week; sonelokimab, 240 mg, every 2 weeks; bimekizumab, 320 mg, every 2 weeks; povorcitinib, 15 mg, once per day; bimekizumab, 320 mg, every 4 weeks; secukinumab, 300 mg, every 4 weeks; and secukinumab, 300 mg, every 2 weeks. Most differences between adalimumab, 40 mg, once per week, and other targeted treatments were not statistically significant. The percentage of patients experiencing SAEs ranged from 0% to 10% in the placebo groups, 0% to 8% in the adalimumab (40 mg, once per week) groups, and 0% to 6% in the other active treatment groups. The percentage of patients discontinuing treatment due to adverse events ranged from 0% to 10% in the placebo groups, 0% to 4% in the adalimumab (40 mg, once per week) groups, and 0% to 15% (ropsacitinib) in the other active treatment groups.

Conclusions and relevance: This network meta-analysis provides evidence for the comparative efficacy and safety of currently approved and pipeline medications for moderate to severe HS in the absence of head-to-head trials.

医学干预治疗中重度化脓性汗腺炎的有效性和安全性:一项实时系统评价和网络荟萃分析。
重要性:关于监管部门批准的化脓性汗腺炎(HS)和正在开发的治疗方法的比较信息有限。目的:比较中重度HS治疗的疗效、安全性和耐受性。数据来源:MEDLINE, Embase, ClinicalTrials.gov和Cochrane Central Register of Controlled Trials从开始到2024年6月28日进行检索。研究选择:医学干预(细胞因子抑制剂、小分子抑制剂、细胞抑制剂和其他新型免疫或炎症调节剂)的2期和3期随机临床试验,用于中度至重度HS成人,初步疗效评估在12至16周之间。数据提取和综合:数据提取和偏倚风险评估由2名审稿人独立完成。疗效结果采用随机效应网络meta分析进行分析。安全性和耐受性结果使用两两固定效应荟萃分析与安慰剂进行分析。数据分析时间为2024年8月22日至2025年4月7日。主要结局和指标:主要疗效、安全性和耐受性分别为化脓性汗腺炎临床反应(HiSCR)-50、严重不良事件(SAEs)的发生和因不良事件而停止治疗。HiSCR-75是次要疗效指标。结果:在26项符合条件的试验中,25项有可用的HiSCR-50数据,包括5767名患者和39种独特的治疗方法。与安慰剂相比,以下治疗与更高的HiSCR-50反应率相关:索奈洛单抗,120 mg,每4周;Lutikizumab, 300mg,每2周;阿达木单抗,40mg,每周1次;索奈洛单抗,240 mg,每2周;比美珠单抗,320 mg,每2周;Povorcitinib, 15 mg,每日1次;比美珠单抗,320 mg,每4周;Secukinumab, 300 mg,每4周;secukinumab, 300mg,每两周一次。阿达木单抗,40mg,每周一次,和其他靶向治疗之间的大多数差异没有统计学意义。发生SAEs的患者比例在安慰剂组为0% - 10%,阿达木单抗组为0% - 8% (40mg,每周一次),其他积极治疗组为0% - 6%。由于不良事件而停止治疗的患者百分比在安慰剂组中为0%至10%,在阿达木单抗(40 mg,每周一次)组中为0%至4%,在其他积极治疗组中为0%至15%(罗帕西替尼)。结论和相关性:该网络荟萃分析为目前已批准和正在开发的药物在没有头对头试验的情况下治疗中重度HS的比较疗效和安全性提供了证据。
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来源期刊
JAMA dermatology
JAMA dermatology DERMATOLOGY-
CiteScore
14.10
自引率
5.50%
发文量
300
期刊介绍: JAMA Dermatology is an international peer-reviewed journal that has been in continuous publication since 1882. It began publication by the American Medical Association in 1920 as Archives of Dermatology and Syphilology. The journal publishes material that helps in the development and testing of the effectiveness of diagnosis and treatment in medical and surgical dermatology, pediatric and geriatric dermatology, and oncologic and aesthetic dermatologic surgery. JAMA Dermatology is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications. It is published online weekly, every Wednesday, and in 12 print/online issues a year. The mission of the journal is to elevate the art and science of health and diseases of skin, hair, nails, and mucous membranes, and their treatment, with the aim of enabling dermatologists to deliver evidence-based, high-value medical and surgical dermatologic care. The journal publishes a broad range of innovative studies and trials that shift research and clinical practice paradigms, expand the understanding of the burden of dermatologic diseases and key outcomes, improve the practice of dermatology, and ensure equitable care to all patients. It also features research and opinion examining ethical, moral, socioeconomic, educational, and political issues relevant to dermatologists, aiming to enable ongoing improvement to the workforce, scope of practice, and the training of future dermatologists. JAMA Dermatology aims to be a leader in developing initiatives to improve diversity, equity, and inclusion within the specialty and within dermatology medical publishing.
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