FDA Approves New Option for Active Still Disease

The US Food and Drug Administration (FDA) has approved Ilaris (canakinumab) injection for treating adult patients with active Still disease, a rare autoimmune disease of unknown etiology.

Active Still disease includes adult-onset Still disease (AOSD), which shares several symptoms with systemic juvenile idiopathic arthritis (SJIA)—a condition already treatable with Ilaris. The similarity of presentation between AOSD and SJIA has suggested that these conditions are part of a disease continuum rather than 2 separate ailments. 

“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. “Today’s approval provides patients with a treatment option.”

The most common adverse effects associated with Ilaris are colds and upper respiratory tract infections, abdominal pain, and injection-site reactions. The prescribing information for Ilaris includes a warning for potential increased risk of serious infections due to interleukin-1 blockade.

—Rebecca Mashaw

Reference:

FDA approves first treatment for adult onset Still’s disease, a severe and rare disease. News release. US Food and Drug Administration; June 16, 2020. Accessed June 17, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-adult-onset-stills-disease-severe-and-rare-disease