Comparative Effectiveness and Durability of Biologics Through 24 Months for Patients with Moderate-to-Severe Psoriasis: Results from the International, Observational Psoriasis Study of Health Outcomes (PSoHO).

IF 3.5 3区 医学 Q1 DERMATOLOGY
Andreas Pinter, Alan Brnabic, Emanuele Trovato, Lluís Puig, Jose-Manuel Carrascosa, Thierry Boyé, Matteo Megna, Silvia Sabatino, Inmaculada De La Torre, Julia-Tatjana Maul
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引用次数: 0

Abstract

Introduction: The Psoriasis Study of Health Outcomes (PSoHO) is an international, prospective, non-interventional study investigating the comparative effectiveness and durability of biologic treatments for patients with moderate-to-severe psoriasis (PsO) over 36 months. Patients were grouped into cohorts based on biologic class: anti-interleukin (IL)-17A/receptor A (anti-IL-17A), anti-IL-12/23, anti-IL-23 and anti-tumor necrosis factor (TNF)-α for the purpose of comparison. Additionally, the durability and effectiveness of individual biologic treatments were compared to ixekizumab (IXE).

Methods: Effectiveness was assessed using Psoriasis Area and Severity Index (PASI) 90 and PASI100 response rates and durability, defined as achieving therapeutic response (PASI90/100) at week 12 and its maintenance at months 6, 12, 18 and 24. Statistical analysis included unadjusted descriptive summaries and model-based comparisons that accounted for baseline confounders using the frequentist model averaging (FMA) framework and marginal structural models (MSM) that accounted for both baseline and time-varying confounders.

Results: Results demonstrated that patients treated with anti-IL-17A biologics had significantly higher odds of achieving PASI100 and PASI90 compared to those treated with anti-IL-12/23 and anti-TNFα biologics. Specifically, at 24 months, IXE showed greater PASI100 and PASI90 response rates compared to adalimumab (ADA) and ustekinumab (UST), with adjusted odds ratios of 1.9 and 2.3 for PASI100 and 2.0 and 2.5 for PASI90, respectively. IXE-treated patients also exhibited higher durability rates for PASI100 and PASI90 compared to ADA, UST, secukinumab (SEC), tildrakizumab (TILD) and guselkumab (GUS), with adjusted odds ratios (non-responder imputation [NRI]) between 1.7 and 4.3 (PASI100) and 1.6 and 4.2 (PASI90), while being similar to risankizumab (RIS).

Conclusion: This study provides valuable real-world data on the long-term effectiveness and durability of biologic treatments for PsO, emphasizing the advantages of anti-IL-17A biologics, particularly IXE, in achieving and maintaining therapeutic responses. These findings support dermatologists in making informed decisions regarding PsO treatment strategies.

Trial number: The study was registered at the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCEPP24207).

生物制剂对中重度银屑病患者24个月的比较疗效和持久性:来自国际观察性银屑病健康结局研究(PSoHO)的结果
银屑病健康结局研究(PSoHO)是一项国际性、前瞻性、非介入性研究,旨在研究生物治疗对中重度银屑病(PsO)患者超过36个月的相对有效性和持久性。根据生物分类将患者分组:抗白细胞介素(IL)-17A/受体A(抗IL-17A)、抗IL-12/23、抗IL-23和抗肿瘤坏死因子(TNF)-α进行比较。此外,将个体生物治疗的持久性和有效性与ixekizumab (IXE)进行了比较。方法:使用银屑病面积和严重程度指数(PASI) 90和PASI100缓解率和持久性来评估有效性,定义为在第12周达到治疗缓解(PASI90/100)并在第6、12、18和24个月维持治疗缓解。统计分析包括未调整的描述性总结和基于模型的比较,这些比较使用频率模型平均(FMA)框架和边际结构模型(MSM)来考虑基线和时变混杂因素。结果:结果表明,与抗il -12/23和抗tnf - α生物制剂相比,抗il - 17a生物制剂治疗的患者达到PASI100和PASI90的几率明显更高。具体来说,在24个月时,IXE比阿达木单抗(ADA)和ustekinumab (UST)显示出更高的PASI100和PASI90缓解率,PASI100的调整优势比分别为1.9和2.3,PASI90的调整优势比分别为2.0和2.5。与ADA、UST、secukinumab (SEC)、tildrakizumab (TILD)和guselkumab (GUS)相比,ixei治疗的患者也表现出更高的PASI100和PASI90耐久率,调整后的优势比(无应答归因[NRI])在1.7 - 4.3 (PASI100)和1.6 - 4.2 (PASI90)之间,与risankizumab (RIS)相似。结论:本研究为PsO生物治疗的长期有效性和持久性提供了有价值的现实数据,强调了抗il - 17a生物制剂,特别是IXE在实现和维持治疗反应方面的优势。这些发现支持皮肤科医生对PsO治疗策略做出明智的决定。试验号:该研究已在欧洲药物流行病学和药物警戒中心网络(ENCEPP24207)注册。
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来源期刊
Dermatology and Therapy
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.
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