A phase III open-label, randomized multicenter study to evaluate efficacy and safety of secukinumab in pediatric patients with moderate to severe plaque psoriasis: 24-week results.

Abstract Background Psoriasis affects 0.13–2.1% of children and adolescents. Despite high unmet need, the current treatment options approved for pediatric psoriasis are limited. Objective Evaluate the efficacy and safety of two secukinumab dosage regimens (low dose: 75/75/150 mg and high dose: 75/150/300 mg) stratified and randomized by weight ( Methods This is a Phase-III, open-label, randomized, multicenter-study (NCT03668613). Results Both secukinumab doses were superior to historical placebo with respect to PASI 75/90 and IGA0/1 responses at Week-12. The estimated probability of a positive treatment effect (i.e., log-Odd Ratio [OR] >0) for secukinumab low or high dose compared to historical placebo is 1 (i.e. 100%). For low and high doses at Week-12, the IGA0/1 response-rates were 78.6% and 83.3% and the PASI90 response-rates were 69% and 76.2%, respectively; PASI75 response-rate was 92.9% for both doses. Limitations This is an open-label study design without a control arm. Conclusion Secukinumab dosing regimens were efficacious and well-tolerated in pediatric patients with moderate-to-severe plaque psoriasis.