Efficacy and safety of apremilast in pediatric patients with moderate-to-severe plaque psoriasis: 16-week results from SPROUT, a randomized controlled trial
- PMID: 38266683
- DOI: 10.1016/j.jaad.2023.11.068
Efficacy and safety of apremilast in pediatric patients with moderate-to-severe plaque psoriasis: 16-week results from SPROUT, a randomized controlled trial
Abstract
Background: Approved systemic treatment options are limited for pediatric patients with moderate to severe plaque psoriasis.
Objective: To assess the efficacy and safety of apremilast over 16 weeks in pediatric patients with plaque psoriasis.
Methods: SPROUT (NCT03701763) was a phase 3, multicenter, randomized, double-blind, placebo-controlled study of apremilast in patients aged 6-17 years with moderate-to-severe psoriasis (Psoriasis Area and Severity Index [PASI] ≥12, body surface area ≥10%, static Physician Global Assessment [sPGA] ≥3) inadequately controlled by/inappropriate for topical therapy. Patients were stratified by age group and randomized (2:1) to apremilast (20 or 30 mg BID based on weight) or placebo for 16 weeks, followed by apremilast extension to 52 weeks.
Results: Of 245 patients randomized (apremilast: 163; placebo: 82), 221 (90%) completed the double-blind phase (apremilast: 149; placebo: 72). Significantly more patients achieved sPGA response and ≥75% reduction in PASI with apremilast than placebo, regardless of baseline age, weight, or disease severity. No new safety signals were observed.
Limitations: Sample size of subgroup analyses.
Conclusions: Improvements in global disease activity and skin involvement were significantly greater in pediatric patients treated with apremilast versus placebo. Adverse events were consistent with the known apremilast safety profile.
Keywords: apremilast; oral; pediatric; psoriasis; systemic treatment.
Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Conflicts of interest Dr Fiorillo is an investigator for Pfizer, Amgen, Galderama, and Leo; received honoraria from Pfizer, Amgen, Galderama, and Leo; is an advisory board member for Pfizer, Amgen, Galderama, and Leo; and is a speaker for Pierre Fabre and Galderma. Dr Becker is an investigator for Amgen; and is a speaker for Pfizer, Regeneron, and Sanofi. Dr Belloni-Fortina is a consultant for Sanofi, Janssen, Novartis, AbbVie, and Pfizer and received fees and honorarium. Dr Armesto is a speaker and an advisory board member for Amgen Inc, Janssen, LEO Pharma, and Novartis. Dr Elewski receives research support from AbbVie, Anaptys-Bio, Boehringer Ingelheim, Bristol Myers Squibb (BMS), Incyte, Leo, Lilly, Novartis, Pfizer, UCB, Ortho dermatology, Janssen; is a consultant for Amgen, Arcutis, Boehringer Ingelheim, BMS, Leo, Lilly, Novartis, UCB, Ortho dermatology, Janssen; and received honoraria from Amgen, Arcutis, Boehringer Ingelheim, BMS, Leo, Lilly, Novartis, UCB, Ortho dermatology, Janssen. Authors Maes, Oberoi, Paris, Zhang, and Z. Zhang are employees and stockholders at Amgen Inc. Dr Arkin received research equipment from Candela; is an investigator for Celgene and Amgen; and is a consultant for AbbVie, Amgen, Regeneron, and Verrica. Dr de Lucas has no conflicts of interest to declare.
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