Spesolimab improves patient-reported outcomes in patients with generalized pustular psoriasis: Results from the Effisayil 1 study.

Autor: Navarini AA; Department of Dermatology and Allergy, University Hospital Basel, Basel, Switzerland., Prinz JC; Department of Dermatology and Allergy, University Clinics, Ludwig-Maximilian-University of Munich, Munich, Germany., Morita A; Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan., Tsai TF; Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan., Viguier MA; Department of Dermatology, Hôpital Robert Debré, Reims, France., Li L; Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China., Thoma C; Boehringer Ingelheim International GmbH, Biberach, Germany., Sivalingam M; Boehringer Ingelheim International GmbH, Ingelheim, Germany., Lebwohl MG; Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Jazyk: angličtina
Zdroj: Journal of the European Academy of Dermatology and Venereology : JEADV [J Eur Acad Dermatol Venereol] 2023 Apr; Vol. 37 (4), pp. 730-736. Date of Electronic Publication: 2023 Jan 23.
DOI: 10.1111/jdv.18820
Abstrakt: Background: Generalized pustular psoriasis (GPP) is a rare inflammatory skin disease with a considerable clinical burden. In the Effisayil™ 1 study, spesolimab, an anti-interleukin-36 receptor monoclonal antibody, demonstrated efficacy in treating GPP flares.
Objectives: To evaluate patient-reported outcomes (PROs) of patients with GPP who were treated with intravenous (IV) spesolimab 900 mg in the Effisayil™ 1 study.
Methods: Fifty-three patients presenting with a GPP flare were randomized (2:1) to receive a single dose of IV spesolimab 900 mg or placebo and were followed for 12 weeks. Four PROs (pain visual analogue scale [pain VAS]; Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue]; Dermatology Life Quality Index [DLQI]; and Psoriasis Symptom Scale [PSS]) were assessed throughout the 12-week study. Minimal clinically important differences (MCIDs) were defined. All data are reported descriptively.
Results: In patients who received spesolimab, improvements from baseline (median [Q1, Q3]) were observed in pain VAS (-21.3 [-55.3, -3.1]), FACIT-Fatigue (7.0 [1.0, 20.0]), DLQI (-2.5 [-8.0, 1.0]) and PSS (-4.0 [-7.0, 0.0]) within 1 week of treatment. These improvements were sustained over 12 weeks and corresponded to the achievement of MCIDs at Week 1, which were also sustained over 12 weeks. Patients in the placebo arm experienced improvements in PROs and achievement of MCIDs after receipt of open-label spesolimab at Week 1.
Conclusions: Patients with a GPP flare treated with spesolimab achieved improvements in PROs by Week 1, which were sustained for 12 weeks, and achieved MCIDs as early as Week 1.
(© 2022 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)
Databáze: MEDLINE
Externí odkaz: