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).
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).
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.