The U.S. Food and Drug Administration approved Ilaris (canakinumab) injection for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD). Ilaris was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older, according to a press release from the agency.
“Prior to the 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.
AOSD is one of a group of rare autoinflammatory diseases that cause disabling and persistent fevers, which may be accompanied by joint pain, swelling, muscle pain and skin rashes with complications that can be life-threatening, according to Novartis, developer of the medication. In August 2016, the European Commission approved Ilaris for a license extension to also treat patients with Adult-Onset Still's Disease (AOSD), Novartis said.
The role of interleukin-1 (IL-1), a type of cytokine important in regulating the body’s immune system, is well-established in AOSD and SJIA, the FDA said. Ilaris works by blocking the effects of IL-1 and suppressing inflammation in patients with this autoinflammatory disorder. The safety and efficacy of Ilaris 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.
Common side effects reported by patients treated with Ilaris are infections (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 IL-1 blockade. 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.
