Summary Safety Review - Ilaris (canakinumab) – Assessing the Potential Risk of Drug Reaction with Eosinophilia and Systemic Symptoms

Ilaris (canakinumab) 

Drug reaction with eosinophilia and systemic symptoms (DRESS), a type of allergic drug reaction with rash, fever, increased white blood cell count, and injury to 1 or more organs

• Health Canada’s safety review found a possible link between the use of Ilaris and the risk of DRESS.

• Health Canada is working with the manufacturer to update the product safety information in the Canadian product monograph (CPM) for Ilaris with a warning about reported cases of DRESS, predominantly in patients with systemic juvenile idiopathic arthritis (sJIA). Health Canada will also inform healthcare professionals about this update through a Health Product InfoWatch communication.

Health Canada reviewed the potential risk of DRESS with the use of Ilaris. The safety review was triggered by a labelling update by the European Medicines Agency and Health Canada’s subsequent review of routine safety reports from the manufacturer of Ilaris.

• Ilaris is a prescription drug belonging to a class of drugs called interleukin-1 (IL-1) inhibitors. It is authorized for sale in Canada for the treatment of various inflammatory conditions, including Still’s disease, a rare type of inflammatory arthritis occurring in children as sJIA and in adults as adult-onset Still’s disease.

• Ilaris has been marketed in Canada since 2010. It is currently available as a sterile solution for injection in 150 mg/1 mL single-use vials. 

• Health Canada reviewed the available information provided by the manufacturer, and from searches of the Canada Vigilance database^a and the scientific literature.

• Health Canada reviewed 27 cases (1 Canadian and 26 international) of DRESS in patients taking Ilaris. Of those 27 cases, 4 were found to be possibly linked to the use of Ilaris, 5 (1 Canadian) were unlikely to be linked and 18 could not be assessed due to missing information. The 4 possible cases were reported in pediatric patients, 3 of whom were being treated for sJIA.

• One death was reported among the 4 possible cases. It is unclear whether DRESS was a contributing factor to the death.

• Health Canada’s review of the available information concluded that there is a possible link between the use of Ilaris and the risk of DRESS.

• Health Canada is working with the manufacturer to update the CPM for Ilaris with a warning about reported cases of DRESS, predominantly in patients with sJIA.

• Health Canada will also inform healthcare professionals about this update through a Health Product InfoWatch communication.

• Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of Ilaris, and other health products, to the Canada Vigilance Program.

• Health Canada will continue to monitor safety information involving Ilaris, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action should new health risks be identified. 

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information, and what is known about the use of Ilaris both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

1. Canadian reports can be accessed through the Canada Vigilance Online Database