Efficacy and safety of apremilast in pediatric patients with moderate-to-severe plaque psoriasis: 16-week results from SPROUT, a randomized controlled trial - 14/05/24
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.
Le texte complet de cet article est disponible en PDF.Key words : apremilast, oral, pediatric, psoriasis, systemic treatment
Abbreviations used : BID, BMI, BSA, CI, CV, LS, PASI, PASI-75, PASI-90, QOL, ScPGA, SD, sPGA, sPGA-G, SPROUT, TEAE, WBI-NRS
Plan
Funding sources: This study was sponsored by Amgen Inc. |
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Prior presentation: Data from the SPROUT study were presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress, Milan, Italy, September 7-10, 2022. |
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Patient consent: Patients provided written assent and their legal guardians provided written informed consent (on file); consent to publish not applicable. |
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IRB approval status: Institutional review board/ethics committee approval was obtained. |
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Data sharing: Qualified researchers may request data from Amgen clinical studies. Complete details are available at datasharing. |
Vol 90 - N° 6
P. 1232-1239 - juin 2024 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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