JUNIPERA: Secukinumab delays time to flare in juvenile PsA, enthesitis-related arthritis
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Secukinumab yielded a significantly longer time to flare than placebo in pediatric patients with enthesitis-related arthritis and juvenile psoriatic arthritis, according to findings presented at the EULAR 2021 Congress.
“The objective of this randomized trial was to evaluate the efficacy and safety profile of secukinumab [Cosentyx, Novartis], a human monoclonal antibody directed against IL-17, in children with active enthesitis-related arthritis and juvenile psoriatic arthritis,” Nicolino Ruperto, MD, MPH, of the department of pediatrics at IRCCS Istituto G. Gaslini, and the Pediatric University of Genova, in Italy, said in his presentation.
The 2-year, open-label study called for the drug to be administered subcutaneously at a dose of 75 mg in patients less than 50 kg and at 150 mg in those 50 kg or greater. Treatments were administered at baseline and weeks 1, 2, 3, 4, 8 and 12 in treatment period one. For patients who reached at least JIA ACR30 response by week 12 were then randomly assigned to a second treatment period, which was double-blinded. Patients were assigned secukinumab or placebo every 4 weeks until a disease flare or through 104 weeks.
“The main objective was to evaluate the time to flare in these two groups,” Ruperto said.
The researchers also assessed for JIA ACR 30/50/70/90/100, inactive disease, JADAS, enthesitis count and safety. The initial cohort for the first treatment period included 97 patients with a mean age of 13.1 years. Just over one-third (33.7%) were female.
There were 52 patients with ERA and 34 with juvenile PsA who were treated in the first period. The baseline mean JADAS-27 score was 15.1. The cohort had a mean enthesitis count of 2.6.
Results at the end of treatment period one showed that 90.4% of the cohort had reached JIA ACR30 response, with 69.9% achieving JIA ACR70. The double-blinded period included 75 patients, with 37 patients receiving active therapy and 38 receiving placebo. Results from treatment period two showed 10 flares in the secukinumab group and 21 in patients treated with placebo.
The researchers reported a significantly longer time to flare in the secukinumab group, along with a 72% risk of flare reduction compared with placebo (HR = 0.28; P < .001). “There was an important discrimination between the two lines, with patients switching to placebo flaring to a greater extent, and sooner, when compared to those who continued with secukinumab,” Ruperto said.
Looking deeper into the findings, 87.2% of patients in the second treatment period reached JIA ACR30 response, while 83.7% reached JIA ACR50, 67.4% JIA ACR70, 38.4% JIA ACR90 and 24.2% reached JIA ACR100.
In addition, 74% of patients with enthesitis experienced complete resolution of this condition, while three of five patients with dactylitis also saw full resolution.
“Both juvenile PsA and ERA are progressive, chronic, debilitating diseases with limited treatment options,” Hermine I. Brunner, MD, MSc, of the Cincinnati Children’s Hospital Medical Center, and lead investigator of the JUNIPERA study, said in a press release. “The JUNIPERA data are encouraging and pave the way for an effective treatment option that delays the worsening of symptoms leading to improvement in quality of life for these children.”
Signs and symptoms showed ongoing improvement through week 104, according to Ruperto.
Adverse events occurred in 91.7% of patients in the secukinumab arm and 92.1% of those in the placebo arm. Serious adverse event rates were 14.6% for secukinumab and 10.5% for placebo. “Few patients discontinued treatment due to adverse events,” Ruperto said.
He added that no new safety signals were observed.
“In children with enthesitis-related arthritis and juvenile psoriatic arthritis, treating with secukinumab demonstrated a significantly longer time to flare when compared to placebo,” Ruperto concluded.
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Ruperto N. LB0004. Efficacy and safety of secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: Primary results from a randomized, double-blind, placebo-controlled, treatment withdrawal, phase 3 study (JUNIPERA). Presented at EULAR 2021 Congress; June 2-6, 2021 (virtual meeting).
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