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A new weight-based secukinumab formulation provides a new option for treatment of adolescents with moderate-to-severe hidradenitis suppurativa (HS) with the FDA’s approval, according to a press release from the manufacturer Novartis.
Secukinumab (Cosentyx) is the only interleukin (IL)-17A inhibitor approved for this patient population, and with weight-based dosing recommended for this age group, according to the press release. It was approved for treating adults with moderate to severe HS in 2023.
Another biologic, the TNF inhibitor adalimumab (Humira) was approved by the FDA for moderate-to-severe HS in patients aged 12 years or older in 2018; the biosimilar adalimumab-aaty (Yuflyma) was approved in 2023.
Approval applies to adolescents aged 12 years or older and weighing at least 30 kg and was based mainly on data extrapolated from the SUNSHINE and SUNRISE clinical trials involving 676 and 687 adults with HS (mean age, 36.1 years). In those studies, patients were randomly assigned to 300 mg subcutaneous secukinumab every 2 weeks or every 4 weeks, or placebo. Overall, significantly more patients receiving secukinumab had an HS clinical response than patients receiving placebo, with results sustained up to 52 weeks and no new safety signals reported.
The IL-17A mechanism of secukinumab allows for weight-based dosing, and a dosing analysis indicated that weight-based dosing in pediatric patients with HS would provide similar exposure to that seen in the adult trials, according to the press release.
Approval also was supported by clinical trial data from three other FDA-approved pediatric indications: Secukinumab is approved for moderate-to-severe plaque psoriasis in children aged 6 years or older, enthesitis-related arthritis in children aged 4 years or older, and active psoriatic arthritis in children aged 2 years or older.
The updated prescribing information is available here.
