Efficacy and safety of secukinumab in juvenile idiopathic arthritis

Secukinumab significantly increased the time to flare and reduced the number of flares in children with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) compared with placebo. The safety profile of secukinumab in this population is congruent with the known safety profile of the drug. These were the main results of the phase 3 randomised, double-blind JUNIPERA trial 104 weeks after treatment initiation [1].

Efficacy and safety of secukinumab, a human monoclonal antibody targeting IL-17, has been demonstrated in adult patients with PsA and radiographic and non-radiographic axial spondyloarthritis [2-4]. JUNIPERA (NCT03031782) aimed to evaluate the efficacy and safety of secukinumab in ERA and JPsA patients (aged 2–18) with a history of inadequate response or intolerance to ≥1 NSAID or ≥1 DMARD. If patients (n=86) reached juvenile idiopathic arthritis (JIA)-ACR30 at the end of a 12-week open-label secukinumab 75/150 mg subcutaneous first treatment period (every week first 4 weeks, then every 4 weeks), they were randomised to secukinumab every 4 weeks (n=37) or placebo (n=38). After the occurrence of a flare in the second treatment period, the patient was moved to another open-label secukinumab treatment period. The primary endpoint was time to disease flare of patients on secukinumab versus placebo in the second treatment period.

Time to flare was significantly longer in the secukinumab arm compared with the placebo arm (HR 0.28; 95% CI 0.13-0.63; P<0.001) (see Figure). The number of flares was lower in the treatment arm (secukinumab 10 vs placebo 21) and JIA-ACR30 was maintained more often for secukinumab-treated patients (89.2%) than for placebo patients (64.9%) after the second treatment period. Dr Nicola Ruperto (IRCCS Istituto G. Gaslini, Italy) argued that the median time to flare of 453 days in the placebo arm indicated a prolonged biological effect of the first treatment period. Complete resolution of enthesitis occurred in 73.9% of the ERA patients after the first treatment period. Adverse events (AEs) were reported in 91.7% of the secukinumab patients and 92.1% of the placebo patients, including 7 and 4 non-fatal serious AEs, respectively. These findings also support the close pathophysiological link between ERA and adult spondyloarthropathy pattern arthritis where IL-17 blockers are also effective.

Figure: Primary endpoint of time to disease flare for secukinumab versus placebo [1]



SEC, secukinumab; TP, treatment period.

1. Ruperto N, et al. Efficacy and Safety of Secukinumab in Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis: Primary Results from a Randomised, Double-blind; Placebo-controlled, Treatment Withdrawal; Phase 3 Study (JUNIPERA). LB0004, EULAR 2021 Virtual Congress, 2–5 June.
2. McInnes IB, et al. Lancet. 2015;386:1137–46.
3. Baeten D, et al. N Engl J Med. 2015;373:2534–48.
4. Deodhar A, et al. Arthritis Rheumatol. 2021;73:110–20.

 

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Posted on 2 August, 202128 March, 2024