FDA Approves First Therapy for Still Disease

The FDA approved canakinumab (Ilaris) injection for the treatment of adult-onset Still disease, which is the first therapy approved for this rare autoimmune disease. Canakinumab is an IL-1 inhibitor that was previously approved for systemic juvenile idiopathic arthritis.

Adult-onset Still disease and systemic juvenile idiopathic arthritis share many characteristics, including rash, fever, arthritis, and elevated markers of inflammation. The role of IL-1 has been well-established in both diseases.

The efficacy and safety of canakinumab for the treatment of patients with adult-onset Still disease was established using comparable pharmacokinetic exposure and extrapolation of the established efficacy and safety of this therapy in patients with systemic juvenile idiopathic arthritis, as well as patients with other diseases including adult-onset Still disease.

Common treatment-related adverse effects include injection-site reactions, abdominal pain, and infections, such as colds and upper respiratory tract infections. In addition, there is a warning for the potential increased risk of serious infections.

Patients with Still disease and other rheumatic conditions may develop macrophage activation syndrome, and this should be treated aggressively. Additionally, immunosuppressant medications may increase the risk of malignancies and patients should not receive live vaccinations during treatment.

Reference
FDA approves first treatment for adult onset Still disease, a severe and rare disease. Press release. FDA. Published June 16, 2020. Accessed https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-adult-onset-stills-disease-severe-and-rare-disease