SJIA drug has comparable efficacy for this rare disease with similar symptoms

WASHINGTON —The FDA approved injectable canakinumab (Ilaris) to treat active Still’s disease — including Adult Onset Still’s Disease (AOSD) — making it the first approved treatment for the rare autoinflammatory disease.

“Prior to today’s approval, patients had no FDA-approved treatments for their disease, which can include symptoms such as painful arthritis, fevers, and rash,” said Nikolay Nikolov, MD, acting director of the Division of Rheumatology and Transplant Medicine in the FDA’s Center for Drug Evaluation and Research, in a statement. “Today’s approval provides patients with a treatment option.”

The symptoms of AOSD are similar to those reported in patients with Systemic Juvenile Idiopathic Arthritis (SJIA), suggesting that “this is a disease continuum rather than two separate diseases,” the FDA noted. Canakinumab, an interleukin-1 inhibitor, was previously approved to treat SJIA in patients ages ≥2 years.

“The safety and efficacy of [canakinumab] for the treatment of patients with AOSD was established using comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with SJIA, as well as the safety of canakinumab in patients with AOSD and other diseases,” the agency noted.

The most common side effects associated with use of canakinumab include infections such as colds and upper respiratory tract infections, abdominal pain, and injection site reactions. “The prescribing information for [canakinumab] includes a warning for potential increased risk of serious infections due to IL-1 blockade,” the FDA warned. “Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with rheumatic conditions, in particular Still’s disease, and should be aggressively treated. Treatment with immunosuppressants may increase the risk of malignancies. Patients are advised not to receive live vaccinations during treatment.”

Canakinumab is manufactured by Novartis Pharmaceuticals Corp.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 158

Topic ID: 90,158,730,138,192,158