Apremilast Maintains Efficacy at 2 Years in Pediatric Psoriasis

Pediatric patients with moderate to severe plaque psoriasis have long faced limited systemic treatment options.¹ Apremilast, the first FDA-approved oral therapy for this population, continues to demonstrate durable efficacy and a stable safety profile over 2 years of continuous use, according to new results from the SPROUT (NCT03701763) extension study.

In an extension trial, apremilast showed sustained clinical benefit and a consistent safety profile in children and adolescents with moderate to severe plaque psoriasis. | luchschenF - stock.adobe.com

The findings from the phase 3, randomized, double-blind, placebo-controlled study were presented at the Society for Pediatric Dermatology (SPD) 50th Annual Meeting on July 24, 2025, in Seattle, WA.

SPROUT was designed to evaluate the efficacy and safety of apremilast in pediatric patients aged 6 to 17 years with moderate to severe plaque psoriasis inadequately managed with topical therapies.² In this 16-week trial, 245 patients were randomized in a 2:1 ratio to receive weight-based doses of apremilast or placebo, followed by an open-label extension through 52 weeks. Apremilast significantly improved clinical outcomes, with more patients achieving static Physician Global Assessment (sPGA) response and at least a 75% reduction in Psoriasis Area and Severity Index (PASI) scores compared with placebo, regardless of baseline characteristics. The treatment was well tolerated, with a safety profile consistent with previous studies in adults. These results supported apremilast’s approval as the first oral systemic therapy for pediatric plaque psoriasis.

“Apremilast showed efficacy regardless of age, weight, or disease severity,” wrote the researchers of the study. “However, greater treatment differences between apremilast and placebo tended to be seen in younger patients and in the lower weight group. It should be noted that patients in the younger group had less severe disease as measured by PASI and BSA [body surface area]. In addition, although sample size was limited, a subgroup analysis suggested that patients with shorter disease duration and no prior biologic or systemic treatments may experience greater benefit with apremilast compared to those with longer disease duration and treatment experience.”

In the extension trial, participants who previously received either apremilast or placebo and completed the core study were eligible to enroll and receive continuous treatment with weight-based dosing of apremilast. ¹ The primary aim of the extension trial is to assess the durability of clinical response—measured by outcomes such as sPGA and PASI scores—while monitoring long-term safety, growth metrics, and tolerability in this population through extended follow-up.

Of the 160 patients who entered the extension study, 104 (65%) completed 2 years of continuous apremilast therapy. The proportion of patients achieving an sPGA score of 0 (clear) or 1 (almost clear) was maintained from week 52 (60.0%) to week 104 (57.8%), indicating durable efficacy. The safety profile remained consistent with both the original SPROUT study and previous adult trials, with no new safety signals identified. Importantly, mean (SD) changes in weight and body mass index from baseline (6.8 [8.2] kg) to cut-off date (0.6 [2.4] kg/m²) were in line with expected growth trajectories for a healthy pediatric population, supporting the long-term tolerability of apremilast in children and adolescents.

Overall, the 2-year results from the SPROUT extension trial reinforce apremilast as a safe and effective long-term treatment option for pediatric patients with moderate to severe plaque psoriasis. Sustained clinical responses and a stable safety profile, including normal growth patterns, underscore its value as the first and only FDA-approved oral systemic therapy in this population. These findings support the continued use of apremilast as a viable alternative for children and adolescents who are inadequately managed with or unable to tolerate topical therapies.

References

1. Paller A, Fiorello L, Becker E, et al. Efficacy and safety of apremilast in pediatric patients with moderate to severe plaque psoriasis: 2-year results from the SPROUT extension trial. Presented at: Society for Pediatric Dermatology Annual Meeting; July 23-26, 2025; Seattle, WA. Abstract POS-09.

2. Fiorillo L, Becker E, de Lucas R. 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