JUNIPERA: Secukinumab reduces flare risk in juvenile PsA, enthesitis-related arthritis
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Secukinumab is efficacious in children and adolescents with psoriatic arthritis and enthesitis-related arthritis, resulting in a significantly longer time to flare versus placebo, according to data presented at ACR Convergence 2021.
“Enthesitis-related arthritis, or ERA, and juvenile psoriatic arthritis, or JPsA, are two JIA categories that constitute the pediatric counterparts of adult non-radiographic axial spondyloarthritis and adult psoriatic arthritis, respectively,” Hermine Brunner, MD, MSc, MBA, of the University of Cincinnati and Cincinnati Children's Hospital Medical Center, told attendees at the virtual meeting. “Secukinumab is a monoclonal antibody targeting interleukin-17A and has been found effective and safe in use in these adult forms of arthritis.”
To examine the efficacy and safety of secukinumab (Cosentyx, Novartis) in active enthesitis-related arthritis and juvenile PsA, Brunner and colleagues conducted the randomized, double-blind, placebo-controlled JUNIPERA trial. Patients aged 2 to younger than 18 years with at least 6 months’ duration of either condition, and active disease, were enrolled. The 2-year study began with an open-label treatment period, in which participant received subcutaneous secukinumab — either 75 mg or 150 mg depending on weight — at baseline and weeks 1, 2, 3, 4, 8 and 12.
Those who achieved at least JIA ACR30 response at week 12 were then randomized into double-blind period, in which they either continued with secukinumab or received a placebo every 4 weeks until they experienced disease flare or week 100. The primary endpoint was the time to flare during the double-blind period. Key secondary endpoints included JIA ACR30/50/70/90/100, inactive disease, juvenile arthritis disease activity score (JADAS), enthesitis, active joint counts and safety.
Analyses included the proportion of patients with disease flare, a Kaplan-Meier estimate of median days for time to flare, hazard ratio estimates, and stratified log-rank test P values. The researchers also performed an intent-to-treat analysis using non-responder imputation, as well as an as-observed analysis, for JIA ACR30/50/70/90/100 responses and inactive disease.
A total of 86 patients were enrolled in the first treatment period, including 52 with enthesitis-related arthritis and 34 with juvenile PsA. Among these participants, 75 achieved JIA ACR30 at week 12 and entered the double-blind period.
According to the researchers, there were 21 flares reported in the placebo group, compared with 10 in those with continued with secukinumab, during the double-blind period. Patients in the secukinumab group demonstrated a significantly longer time to flare, compared with the placebo group, resulting in a 72% reduced risk for flare (HR = 0.28; 95% CI, 0.13-0.63).
There were minor differences between the intent-to-treat and as-observed analyses regarding JIA ACR responses and inactive disease during the first treatment period, the researchers wrote. In addition, Brunner and colleagues reported improved JADAS-27 scores in patients with either enthesitis-related arthritis or juvenile PsA.
Regarding safety, rates of adverse events — 91.7% for secukinumab versus 92.1% for placebo — and serious adverse events — 14.6% versus 10.5%, respectively — in were comparable for the duration of the study. There were no new safety signals among those who received secukinumab, with one injection site reaction across a total of 141.5 patient-years.
“In children and adolescents with ERA or JPsA, secukinumab demonstrated a significantly longer time to flare, and fewer number of flares, compared with placebo,” Brunner said. “There was sustained improvement of signs and symptoms up to week 104. The safety profile in this pediatric population was consistent with the known safety profile of secukinumab.”
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Brunner H. Abstract 1424. Presented at: ACR Convergence 2021; November 5-9, 2021 (virtual meeting).
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