'Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms,' said
ERA and juvenile PsA (JPsA), subtypes of juvenile idiopathic arthritis (JIA), are autoimmune diseases3,4,5. ERA is characterized by joint swelling and pain where tendons and ligaments attach to bone and may present with low back pain or tenderness at the palpation of the hips6. JPsA is characterized by joint swelling and skin psoriasis and may present with nail changes, inflammation of fingers and/or toes, or psoriatic skin changes in a first-degree relative6. If left untreated, they can lead to high levels of pain and disability3,4,5.
'The FDA approvals for JPsA and ERA follow the approval of Cosentyx as a first-line systemic treatment for pediatric psoriasis earlier this year, and further reinforce the commitment of Novartis to the pediatric community,' said
The approved pediatric dosing for Cosentyx in children and adolescents is 75 mg (body weight: 15 kg 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 four weeks after initial loading doses1. 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 17 years with a confirmed diagnosis of ERA or JPsA according to a modified
(C) 2021 Electronic News Publishing, source