Efficacy and safety of apremilast in pediatric patients with moderate to severe plaque psoriasis: 52-week results from the SPROUT randomized controlled trial.

Authors

Amy S Paller, Loretta Fiorillo, Emily Becker, Susana Armesto, Apostolos Kontzias, Rajneet K Oberoi, Wendy Zhang, Hamid Amouzadeh, Zuoshun Zhang, Lisa Arkin

Published in

The British journal of dermatology. Jul 30, 2025. Epub Jul 30, 2025.

Abstract

Oral treatment options for pediatric patients with moderate to severe plaque psoriasis are limited. In the 16-week, placebo-controlled, double-blinded phase of the SPROUT trial, apremilast demonstrated efficacy compared with placebo in pediatric patients with psoriasis.
To evaluate the 52-week efficacy and safety of apremilast in SPROUT.
SPROUT was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study (NCT03701763). Patients were randomized 2:1 to receive apremilast 20 or 30 mg (for patients 20-<50 or ≥50 kg at baseline, respectively) twice daily or placebo for 16 weeks, after which all patients received apremilast through week 52 (apremilast/apremilast or placebo/apremilast, respectively). Patients were aged 6 to 17 years, with moderate to severe psoriasis inadequately controlled by or intolerant to topical therapy.
Of 245 patients randomized, 221 (apremilast/apremilast: 149; placebo/apremilast: 72) entered the apremilast extension phase and 186 (apremilast/apremilast: 125; placebo/apremilast: 61) completed 52 weeks. With continued apremilast treatment, rates of static Physician Global Assessment (sPGA) response (score of 0 or 1 with ≥2-point reduction from baseline) further improved from Week 16 (30.1%) to Week 52 (47.7%). In the placebo/apremilast group, sPGA response rates increased from 9.8% at Week 16 to 44.4% at Week 52. The proportions of patients with ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI-75) increased from 42.3% at Week 16 to 60.4% at Week 52 in the apremilast/apremilast group and from 13.4% to 63.9% in the placebo/apremilast group. No new safety signals were observed.
Improvements in clinical outcomes were sustained through 52 weeks with apremilast treatment in pediatric patients with moderate to severe psoriasis. Safety findings were consistent with the known safety profile.
NCT03701763.

PMID:
40737559
Bibliographic data and abstract were imported from PubMed on 31 Jul 2025.

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