JUNIPERA: Secukinumab improves outcomes in juvenile PsA, ERA
medwireNews: Children and adolescents with juvenile psoriatic arthritis (PsA) or enthesitis-related arthritis (ERA) may benefit from treatment with the interleukin (IL)-17A inhibitor secukinumab, indicate phase 3 study results.
The JUNIPERA trial had a flare-prevention design, and included 86 participants aged 2–17 years with active juvenile PsA or ERA and an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs and at least one DMARD. All patients were treated with open-label secukinumab 75 or 150 mg every 4 weeks (following once-weekly loading doses at weeks 0–4) for 12 weeks in period 1, after which time those with a JIA ACR30 response (n=75) were randomly assigned to continue secukinumab or switch to placebo in period 2 and followed up until week 104 maximum.
Speaking at the EULAR 2021 Virtual Congress, Nicolino Ruperto (Università di Genova Pediatria, Italy) noted that the majority (approximately 65–70%) of participants received concomitant methotrexate, and patients had “a high degree of disease activity” at baseline, as indicated by an average JADAS-27 score of around 15 points.
Ruperto reported that participants treated with secukinumab were a significant 72% less likely to experience a disease flare during period 2 than those who switched to placebo. He said that the median time to flare in the placebo arm was 453 days, pointing to a “prolonged biologic effect” of secukinumab.
Patients treated with secukinumab also experienced significantly better JIA ACR30 (89.2 vs 64.9%) and 70 (67.6 vs 43.2%) response rates during period 2 than those switching to placebo, as well as numerically higher JIA ACR50 response rates and percentage of patients with inactive disease.
When average JADAS-27 scores were evaluated over time in patients who received secukinumab throughout the study, Ruperto said that there was an initial rapid improvement following secukinumab initiation in period 1, reaching the threshold for low disease activity (≤3.8 points) during the first 12 weeks of treatment, with low disease activity maintained during period 2.
In all, adverse events occurred in 91.7% of secukinumab-treated patients and 92.1% of those given placebo in period 2; the corresponding rates of serious adverse events in these two groups were 14.6% and 10.5%. There were no deaths in the study.
The safety profile of secukinumab in JUNIPERA “was consistent with the known safety profile in trials [of secukinumab] in adult patients,” said Ruperto.
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