Key messages
- Studio di fase 3 in aperto, randomizzato, multicentrico, per valutare l’efficacia e la sicurezza di secukinumab nei pazienti pediatrici con psoriasi in placche moderata-severa: risultati a 24 settimane.
- I differenti regimi di dosaggio di secukinumab sono stati efficaci e ben tollerati nei pazienti pediatrici con psoriasi moderata-severa.
Abstract
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.