Abstract: Pediatric patients with moderate-to-severe plaque psoriasis have limited systemic treatment options. Apremilast?an oral phosphodiesterase-4 inhibitor approved for adult psoriasis, psoriatic arthritis, and Beh?et?s disease?has recently become the only FDA-approved oral treatment for pediatric moderate-to-severe plaque psoriasis. SPROUT (NCT03701763)?a phase 3, randomized, double-blind, placebo controlled study of apremilast?enrolled patients 6e17 years with moderate-to severe psoriasis inadequately controlled by/intolerant to topical therapy.1 Patients were stratified by age group and treated (2:1) with apremilast (weight-based: 20mg for $20e\50 kg or 30mg for $50 kg, twice-a-day) or placebo for 16 weeks, after which all patients received apremilast through 52 weeks; those who completed SPROUT could participate in the SPROUT extension study (NCT04175613). We report efficacy at 104 weeks and safety through data cut-off (June 7, 2024), data as observed. Of 245 randomized patients (apremilast: 163; placebo: 82), 160 (apremilast-to-apremilast: 106 [65.0%]; placebo-to-apremilast: 54 [65.9%]) entered the extension; overall, 104 (65.0%) completed 104 weeks of apremilast treatment. Proportion of patients achieving sPGA 0/1 was maintained from week 52 (60.0%) to 104 (57.8%). The safety profile remained consistent with findings in SPROUT and adult studies. By last assessment (through cut-off date), patients experienced a mean (standard deviation) weight increase from baseline 6.8 kg (8.2); importantly, BMI change from baseline was 0.6 kg/m2 (2.4). Changes in weight/BMI are consistent with a healthy pediatric population. After 2 years of apremilast treatment in the SPROUT pediatric psoriasis extension study, efficacy was maintained and safety remained consistent with the established profile.

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