Cosentyx receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis.
Cosentyx is now the first biologic indicated for ERA, and the only biologic treatment approved for both ERA and PsA in pediatric patients in the US. These are the second and third approvals for Cosentyx in a pediatric population in the US, and Cosentyx now has a total of five indications across rheumatology and dermatology.
“Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms,” said Hermine Brunner, M.D., Cincinnati Children’s Hospital. “The findings from the Phase III JUNIPERA trial show that pediatric patients treated with secukinumab demonstrated marked responses throughout the treatment period. This approval is positive news for some patients who continue to struggle with painful symptoms like inflammation of the joints and swollen fingers and toes.”
The approved pediatric dosing for Cosentyx in children and adolescents is 75 mg (15 kg or more to less than 50 kg) or 150 mg (50 kg or more). It is administered as a subcutaneous injection by a pre-filled syringe or Sensoready pen every 4 weeks after initial loading doses. With appropriate guidance/instruction from a healthcare professional, Cosentyx can be administered by an adult caregiver outside of a healthcare provider’s office via a single-dose prefilled syringe or Sensoready pen.
The approval is based on data from the Phase III JUNIPERA study, a two-year, three-part, double-blind, placebo-controlled, randomized-withdrawal trial that enrolled 86 children and adolescents aged 2 to 18 years old with a confirmed diagnosis of ERA or JPsA according to a modified International League of Associations for Rheumatology classification criteria. The primary endpoint of the study was time to flare in the treatment period 2 (Week 12 to Week 104)7. In children and adolescents aged 2 to 18 years old, the study demonstrated that patients with active JPsA (n = 34; mean age: 12.2) treated with Cosentyx had a longer time to flare, showing an 85% reduction in the risk of flare (P<0.001) versus placebo. the study also demonstrated that patients with active era (n="52;" mean age: 13.7) treated with cosentyx had a significantly longer time to flare, showing a 53% reduction in the risk of flare versus placebo. safety in this pediatric population was consistent with the known safety profile of cosentyx for the treatment of plaque psoriasis, psa, non-radiographic axial spondyloarthritis and ankylosing spondylitis.
Novartis has filed a regulatory submission for Cosentyx in ERA and JPsA in Europe with a decision anticipated in the coming months.
Related news and insights
Novartis announced the FDA has approved Cosentyx (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older.