Secukinumab Well-Tolerated in Pediatric Patients With Plaque Psoriasis

Pooled safety data from 2 studies support a favorable safety profile of secukinumab in pediatric patients with moderate to severe and severe chronic plaque psoriasis, researchers reported online ahead of print in the American Journal of Clinical Dermatology. 

“Secukinumab was equally well tolerated in pediatric patients across age and bodyweight subgroups, and the overall safety profile was consistent with that of adult patients, with no new or unexpected safety signals,” wrote corresponding author Michael Sticherling, MD, of the University Hospital Erlangen Department of Dermatology in Germany, and study coauthors. 

The study reported pooled safety of secukinumab up to 52 weeks from 2 pivotal phase 3 trials, one an open-label trial and one a double-blind trial. Pooled safety data from 4 pivotal adult trials of secukinumab was also presented. The analysis included a total 198 pediatric patients and 1989 adult patients.

The overall exposure-adjusted incidence of treatment-emergent adverse events per 100 patient-years was 198.8 in the secukinumab-treated pediatric pool, 266.3 in the etanercept pediatric pool, and 256.1 in the adult pool, according to the study. 

By age, adverse event incidence rates with secukinumab were 167.7 per 100 patient-years in patients aged 6 through 11 and 214.7 per 100 patient-years in patients aged 12 through 17. By weight, adverse events incidence rates with secukinumab were 177.3 per 100 patient-years for patients weighing less than 25 kg, 192.5 per 100 patient-years for patients weighing between 25 kg and 49 kg, and 206.8 per 100 patient-years in patients weighing 50 kg or higher.

Across age and weight subgroups of pediatric patients, nasopharyngitis was the most frequently reported adverse event, the analysis showed. Transient and mostly mild neutropenia events were also reported, although none resulted in treatment discontinuation. 

“Candida infections were reported to be less frequent in pediatric patients compared with adults; they were mild,” researchers wrote, “and did not lead to study treatment discontinuation or interruption.”

Reference: 
Sticherling M, Nikkels AF, Hamza AM, et al. Secukinumab in pediatric patients with plaque psoriasis: pooled safety analysis from two phase 3 randomized clinical trials. Am J Clin Dermatol. Published online June 21, 2023. doi:10.1007/s40257-023-00782-8