A long-term, prospective, observational cohort study of the safety and effectiveness of etanercept for the treatment of patients with paediatric psoriasis in a naturalistic setting.

Autor: Gu Y; Global Medical Epidemiology, Pfizer Inc., 500 Arcola Road, Dock E, Collegeville PA, 19426, USA., Brinkley E; Real-World Solutions, IQVIA, Emperor Boulevard, Durham, NC 27703, USA., Largent J; Real-World Solutions, IQVIA, Emperor Boulevard, Durham, NC 27703, USA., Sobel RE; Global Medical Epidemiology, Pfizer Inc., 235 E 42nd Street, New York, NY 10017, USA., Colli S; Real-World Solutions, IQVIA, Emperor Boulevard, Durham, NC 27703, USA., Thaҫi D; Institute and Comprehensive Center for Inflammation Medicine, University of Luebeck, Ratzeburger Allee 160 in 23538 Luebeck, Germany., Seyger M; Radboud University Nijmegen Medical Center, Department of Dermatology, Nijmegen, The Netherlands., Szalai Z; Heim Pál Children's Hospital, Department of Dermatology, 1089 Budapest Üllői út 86, Hungary., Lacour JP; Department of Dermatology, University of Nice Côte d'Azur, Nice, France., Ståhle M; Division of Dermatology, Department of Medicine, Karolinska Institutet, 17176, Stockholm, Sweden.
Jazyk: angličtina
Zdroj: European journal of dermatology : EJD [Eur J Dermatol] 2023 Feb 01; Vol. 33 (1), pp. 25-33.
DOI: 10.1684/ejd.2023.4404
Abstrakt: Background: Psoriasis is a chronic inflammatory skin disorder that affects 125 million people worldwide, with one-third having childhood onset.
Objectives: The PURPOSE study evaluated long-term safety and effectiveness of etanercept in paediatric psoriasis.
Materials & Methods: This observational study enrolled patients with paediatric psoriasis who were prescribed etanercept per routine care in eight EU countries. Patients were followed retrospectively (first dose prior to 30 days before enrolment) or prospectively (first dose within 30 days prior to or any time after enrolment) for five years. Safety endpoints included serious infections, opportunistic infections, malignancies, other serious adverse events (SAEs) and adverse events. Effectiveness endpoints (prospective patients) included treatment patterns, dose change/discontinuation, and physicians' global subjective assessment of change in disease severity from baseline to follow-up.
Results: In total, 72 patients were enrolled (32 prospectively, 40 retrospectively), with mean age of 14.5 years and mean disease duration of 7.1 years. No serious or opportunistic infections/malignancies were reported. Psoriasis (n=8) and subcutaneous tissue disorders (system organ class) (erythema nodosum, erythrodermic psoriasis; n=1 for each) were the most frequently reported SAEs, which occurred in six (8.3%) patients with current/recent treatment and four (7.4%) with previous treatment. Of 25 treatment-emergent SAEs, seven (28.0%) were possibly related to etanercept. Assessments of prospective patients revealed that 28 (87.5%) completed 24 weeks, five (15.6%) required at least one subsequent course, and 93.8% experienced decreased disease severity. It is possible that some rare adverse events were not noted in this relatively small sample.
Conclusion: These real-world data are consistent with the known safety and efficacy profile of etanercept in paediatric patients with moderate to severe plaque psoriasis.
Databáze: MEDLINE
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