Latebreakers: TNF-blocker Humira gets OK for juvenile rheumatoid arthritis

March 10, 2008

Adalimumab approved for polyarticular juvenile idiopathic arthritis.

Adalimumab (Humira, Abbott) may now be marketed for yet another indication – to reduce the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA), commonly referred to as juvenile rheumatoid arthritis. This marks the sixth approved indication for the biologic therapy. The new JIA approval was based on the results of a 48-week Phase III study that included 171 children with the condition, a form of arthritis that affects five or more joints, usually on one side of the body. Results showed that fewer children treated with adalimumab experienced disease flare compared with placebo. According to Abbott, JIA patients weighing 30 kg or more should use the 40-mg prefilled syringe currently used by adult patients, while children weighing between 15 kg and 29 kg should receive the 20-mg prefilled syringe dose. Adalimumab is also indicated to treat certain patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and chronic plaque psoriasis. The therapy works by blocking tumor necrosis factor alpha (TNF-alpha), a key player in the inflammatory responses of some autoimmune diseases.