Comparative effectiveness of biologics in clinical practice : week 12 primary outcomes from an international observational psoriasis study of health outcomes (PSoHO)
Pinter, Andreas (University Hospital of Frankfurt (Alemanya))
Puig Sanz, Lluís (Institut d'Investigació Biomèdica Sant Pau)
Schäkel, Knut (Heidelberg University Hospital (Alemanya))
Reich, Adam (Institute of Medical Sciences. Medical College of Rzeszow University)
Zaheri, Shirin (Imperial College Healthcare NHS Trust)
Costanzo, Antonio (Humanitas Research Hospital Pieve Emanuele (Milà, Itàlia))
Tsai, Tsen-Fang (National Taiwan University Hospital and National Taiwan University College of Medicine)
Smith, Saxon Donald (Australian National University,College of Health and Medicine)
Lynde, Charles W. (University of Toronto)
Brnabic, Alan (Eli Lilly and Company)
Reed, Catherine L. (Eli Lilly and Company)
Hill, Julie (Eli Lilly and Company)
Schuster, Christopher F. (Medical University of Vienna)
Riedl, Elisabeth (Medical University of Vienna)
Paul, Carle (Paul Sabatier University and Larrey Hospital (Toulose, França))
Universitat Autònoma de Barcelona

Date:	2022
Abstract:	Background: Clinical trials study treatment outcomes under stringent conditions, capturing incompletely the heterogeneity of patient populations and treatment complexities encountered in real-world practice. Objectives: To compare the effectiveness of anti-interleukin (IL)-17A biologics relative to other approved biologics in patients with moderate-to-severe psoriasis. Methods: The Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year observational cohort study in adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. Primary study endpoint is the proportion of patients achieving 90% improvement in Psoriasis Area and Severity Index (PASI 90) and/or static Physician Global Assessment (sPGA) 0/1 at Week 12 (W12) in the anti-IL-17A cohort (ixekizumab [IXE], secukinumab) vs. all other approved biologics. Secondary outcomes include the proportion of patients who achieve PASI 75/90/100, absolute PASI scores ≤5, ≤2 and ≤1, Dermatology Life Quality Index (DLQI) score of 0/1 at W12 between the two cohorts and among the individual biologics. Comparative effectiveness analyses were conducted using Frequentist Model Averaging (FMA), a novel causal inference machine learning approach. Missing data for binary outcomes were imputed as non-response. Results: Patient profiles in the anti-IL-17A cohort and other biologics cohort were similar, with more frequent comorbid psoriatic arthritis and less frequent exposure to conventional treatments in the patients receiving anti-IL-17A biologics. At W12, 71. 4% of patients who received an anti-IL-17A biologic achieved PASI 90 and/or sPGA 0/1 compared to 58. 6% of patients who received other biologics (odds ratios [OR], 1. 9; 95% confidence intervals [CI], [1. 6, 2. 4]). Similar findings were observed for secondary outcomes. Conclusions: These results reflect the high efficacy and early onset of skin clearance of IL-17A inhibitors observed in randomized clinical trials and confirm the effectiveness of anti-IL-17A biologics in the real-world setting.
Note:	Altres ajuts: Eli Lilly and Company.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Adult ; Arthritis, Psoriatic ; Biological Products ; Humans ; Psoriasis ; Severity of Illness Index ; Sulfonamides ; Treatment Outcome
Published in:	Journal of the European Academy of Dermatology and Venereology, Vol. 36 Núm. 11 (november 2022) , p. 2087-2100, ISSN 1468-3083

DOI: 10.1111/jdv.18376
PMID: 35766124

14 p, 695.4 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles