Apremilast for Pediatric Patients With Moderate To Severe Plaque Psoriasis

According to a study published in the Journal of the American Academy of Dermatology, global disease activity and skin involvement were shown to be significantly greater in pediatric patients treated with apremilast vs placebo.

Researchers conducted the SPROUT study (NCT03701763) to evaluate the efficacy and safety of apremilast, an oral phosphodiesterase-4 inhibitor, in pediatric patients with moderate to severe plaque psoriasis. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial involved patients aged 6 to 17 years who had a Psoriasis Area and Severity Index (PASI) score of ≥12, body surface area involvement of ≥10%, and a static Physician Global Assessment (sPGA) score of ≥3. These patients were inadequately controlled by, or were inappropriate for, topical therapy. Participants were randomized 2:1 to receive either apremilast (20 or 30 mg twice daily based on weight) or a placebo for 16 weeks, followed by an apremilast extension to 52 weeks.

A total of 245 patients were randomized (163 to apremilast, 82 to placebo), with 221 (90%) completing the double-blind phase. Patients treated with apremilast showed significantly higher rates of achieving sPGA response and ≥75% reduction in PASI score compared to the placebo group, regardless of baseline age, weight, or disease severity. Importantly, no new safety concerns emerged, and adverse events aligned with the known safety profile of apremilast.

While subgroup analysis was limited by sample size, the study demonstrated that apremilast significantly improved disease activity and skin involvement in pediatric patients with moderate to severe plaque psoriasis. These findings support apremilast as a viable treatment option for this population.

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