The U.S. Food and Drug Administration (FDA) has approved Ilaris (canakinumab) to treat Still’s disease.

Still’s disease is a rare autoinflammatory disease of unknown origin. It is similar to systemic juvenile idiopathic arthritis (SJIA), another rare autoimmune disease that canakinumab is approved to treat. Common symptoms in both conditions includes fever, arthritis, rash and elevated markers for inflammation. Current thinking would indicate that these conditions are a continuum of one condition.

Canakinumab interferes with interkeukin-1 (IL-1), a cytokine involved in the exaggerated immune response seen in Still’s disease (and SJIA). 

Unlike most FDA approvals, this approval was largely based on safety data involving patients with adult onset Still’s disease and other conditions receiving canakinumab. The drug’s effectiveness in Still’s disease was largely based on extrapolating efficacy and pharmacokinetic from previous studies involving patients with SJIA.

In a news release, Nikolay Nikolov, MD, of FDA’s Center for Drug Evaluation and Research stated  “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. ” Dr. Nikolov added, “Today’s approval provides patients with a treatment option.”

Common side effects with canakinumab include infections (colds and upper respiratory tract infections), abdominal pain and injection-site reactions.  The medication comes with a warning for potential increased risk of serious infections due to IL-1 blockade. 

To learn more about this and other autoimmune conditions, visit



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