Efficacy and Safety of Apremilast in Pediatric Patients With Moderate-to-Severe Plaque Psoriasis

A recent phase 3, multicenter, randomized, double-blind, placebo-controlled study assessed the efficacy and safety of apremilast in pediatric patients with moderate-to-severe plaque psoriasis.

Systemic treatment options for this population are currently limited. To fill this gap,  the SPROUT study enrolled 245 patients aged 6 to 17 years with moderate-to-severe plaque psoriasis, characterized by a Psoriasis Area and Severity Index (PASI) ≥ 12, body surface area ≥ 10%, and static Physician Global Assessment (sPGA) ≥ 3. Patients were randomized 2:1 to receive either weight-based dosing of apremilast (20 or 30 mg twice daily) or placebo for 16 weeks, followed by an apremilast extension period lasting up to 52 weeks. Participants were stratified by age group.

After 16 weeks, more patients treated with apremilast achieved an sPGA response and a ≥ 75% reduction in PASI compared with those receiving placebo. These improvements were observed consistently across subgroups, including variations in age, weight, and baseline disease severity. Of the 245 patients, 221 (90%) completed the double-blind phase, with 149 in the apremilast group and 72 in the placebo group.

Adverse events associated with apremilast treatment aligned with its established safety profile, and no new safety signals emerged during the study.

“Improvements in global disease activity and skin involvement were significantly greater in pediatric patients treated with apremilast versus placebo,” the authors concluded.

Reference

Fiorillo L, Becker E, de Lucas R, et al. Efficacy and safety of apremilast in pediatric patients with moderate-to-severe plaque psoriasis: 16-week results from SPROUT, a randomized controlled trial. J Am Acad Dermatol. 2024;90(6):1232-1239. doi:10.1016/j.jaad.2023.11.068