European Medicines Agency Committee Issues Positive Opinion for Secukinumab in Pediatric Arthritic Disease

On May 19, 2022, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) issued a positive opinion in favor of expanding the indications for secukinumab (Cosentyx) to include juvenile idiopathic arthritis (JIA) in the categories of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (PsA). This indication would be for patients at least 6 years old who are intolerant of conventional therapy or for whom conventional therapy has proved inadequate. If approved, secukinumab could be used as monotherapy or combined with methotrexate in the European Union.¹

The committee’s positive opinion was based on data from the phase 3 JUNIPERA study, which was a three-part withdrawal trial that lasted two years. This double-blind, placebo-controlled, randomized study showed that both patients with pediatric ERA and those with juvenile PsA who received secukinumab took a significantly longer time to flare than patients who received placebo (P<0.001). No new safety signals were identified in this population.²

In late 2021, as previously reported in The Rheumatologist, secukinumab was approved by the U.S. Food & Drug Administration (FDA) to treat active ERA in patients aged 4 years and older. The agency also extended the approval of secukinumab to treat PsA to include patients aged 2 years and older.³

Other countries have also approved secukinumab to treat pediatric patients. In 2021, secukinumab was approved in Japan to treat patients at least 6 years old with PsA and/or psoriasis. Earlier this year, secukinumab was approved in Brazil to treat patients at least 4 years old with ERA and patients at least 2 years old with juvenile PsA.⁴

References

1. Cosentyx. European Medicines Agency. 2022 May 19.
2. Ruperto N, Foeldvari I, Alexeeva E, 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). Ann Rheum Dis. 2021 Jun. 80(suppl 1):201–202.
3. News release: Novartis Cosentyx receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. Novartis AG. 2021 Dec 23.
4. News release: Novartis Cosentyx (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions. Novartis AG. 2022 May 20.