Efficacy of Secukinumab Across Subgroups and Overall Safety in Pediatric Patients with Moderate to Severe Plaque Psoriasis: Week 52 Results from a Phase III Randomized Study.

BACKGROUND: The efficacy and safety of biologic treatments for children and adolescents with moderate to severe psoriasis should be examined over a considerable time period and in different subgroups. OBJECTIVE: We report the efficacy and safety of secukinumab low dose (LD) and high dose (HD) regimens in pediatric patients with moderate to severe psoriasis for up to Week 52. METHODS: This was a randomized, open-label, parallel-group, multicenter study in patients aged  6 to < 18 years. Patients were randomized in a 1:1 ratio to receive LD (75/75/150 mg; N = 42) or HD (75/150/300 mg; N = 42) subcutaneous secukinumab. At randomization, patients were stratified by weight (< 25, 25 to < 50, ≥ 50 kg) and disease severity (moderate/severe). The study is ongoing; the present analysis included data up to Week 52 collected from August 29, 2018 (first patient first visit) to May 28, 2020 (last patient last visit for Week 52). Efficacy was measured using Investigator's Global Assessment modified 2011 0/1 (IGA 0/1) and Psoriasis Area Severity Index (PASI) 75/90/100 response. Safety outcomes included assessment of adverse events. RESULTS: Of the 84 enrolled patients, 78 (92.9%) completed 52 weeks of treatment. Overall, response rates for PASI 75 and IGA 0/1 were similar between the LD (92.8/88.9%) and HD (93.3/84.7%) groups at Week 52. In the LD and HD groups, PASI 90/100 responses at Week 52 were 78.7/53.5% and 84.7/70.0%, respectively. The proportions of IGA 0/1 and PASI 75/90 responders were comparable for the age, body weight, and disease severity subgroups in the secukinumab LD and HD groups. Mean absolute PASI change from baseline at week 52 was - 17.3 ± standard deviation 5.0 and - 18.2 ± 7.0, a percentage change of - 94.3 and - 94.5% for the LD and HD groups, respectively. More than 70% of evaluable patients achieved Children's Dermatology Life Quality Index 0/1 at Week 52 (LD 70.7%; HD 70.3%). The safety profile was consistent with that in adults, with no new safety signals for either secukinumab dosing regimen. CONCLUSION: A high proportion of pediatric patients with psoriasis responded to both dosing regimens of secukinumab and maintained clinical responses through 52 weeks of treatment. No clinical difference was observed in the efficacy of secukinumab across the pediatric subgroups. Safety events were consistent with the established safety profile of secukinumab. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03668613.