A phase 3 open-label, randomized multicenter study to evaluate efficacy and safety of secukinumab in pediatric patients with moderate to severe plaque psoriasis: 24-week results

Background Psoriasis affects 0.13%-2.1% of children and adolescents. Despite a high unmet need, the current treatment options approved for pediatric psoriasis are limited. Objective To evaluate the efficacy and safety of 2 secukinumab dosage regimens (low dose: 75/75/150 mg; high dose: 75/150/300 mg) stratified and randomized by weight (<25 kg, 25 to <50 kg, ≥50 kg) and disease severity (moderate, severe) in pediatric patients aged 6-<18 years with moderate to severe plaque psoriasis. Methods This is a phase 3, open-label, randomized, multicenter study (NCT03668613). Results Both secukinumab doses were superior to historical placebo with respect to psoriasis area and severity index (PASI)-75/90 and investigator global assessment 0/1 responses at week 12. The estimated probability of a positive treatment effect (ie, log odds ratio > 0) for low- or high-dose secukinumab compared to historical placebo is 1 (ie, 100%). For the low and high doses at week 12, the investigator global assessment 0/1 response rates were 78.6% and 83.3%, respectively, and the PASI-90 response rates were 69% and 76.2%, respectively. The PASI-75 response rate was 92.9% for both the 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. Psoriasis affects 0.13%-2.1% of children and adolescents. Despite a high unmet need, the current treatment options approved for pediatric psoriasis are limited. To evaluate the efficacy and safety of 2 secukinumab dosage regimens (low dose: 75/75/150 mg; high dose: 75/150/300 mg) stratified and randomized by weight (<25 kg, 25 to <50 kg, ≥50 kg) and disease severity (moderate, severe) in pediatric patients aged 6-<18 years with moderate to severe plaque psoriasis. This is a phase 3, open-label, randomized, multicenter study (NCT03668613). Both secukinumab doses were superior to historical placebo with respect to psoriasis area and severity index (PASI)-75/90 and investigator global assessment 0/1 responses at week 12. The estimated probability of a positive treatment effect (ie, log odds ratio > 0) for low- or high-dose secukinumab compared to historical placebo is 1 (ie, 100%). For the low and high doses at week 12, the investigator global assessment 0/1 response rates were 78.6% and 83.3%, respectively, and the PASI-90 response rates were 69% and 76.2%, respectively. The PASI-75 response rate was 92.9% for both the doses. This is an open-label study design without a control arm. Secukinumab dosing regimens were efficacious and well tolerated in pediatric patients with moderate to severe plaque psoriasis.