Safety Information
To date, canakinumab has been given to several thousand individuals with auto-inflammatory disorders, diabetes, arthritis, or gout and has demonstrated a favorable safety and tolerability profile as evidenced by a low number of adverse events and no specific target organ toxicity. As a targeted IL-1β antibody, canakinumab not surprisingly has very low potential for drug-drug interactions. In studies of type 2 diabetes patients, canakinumab has not significantly altered lipid profiles.
Due to the mode of action of all inhibitors of the IL-1 pathway, all patients receiving canakinumab have undergone close monitoring for infections. Compared to placebo canakinumab associates with mildly increased rates of infection, although these have generally been mild to moderate in severety, seldom serious, and either resolved spontaneously or with standard therapy. Nonetheless, all individuals with a history of or at high risk for either tuberculosis or HIV related disease will not be eligible for CANTOS, nor will any individuals with chronic infections or the need for other systemic anti-inflammatory therapies. Drug-induced autoimmune syndromes, observed with other anti-cytokine agents and caused by potential immune modulation, have not been observed with canakinumab. To date, antibodies to canakinumab (immunogenicity) have not been detected.
Due to the mode of action of all inhibitors of the IL-1 pathway, all patients receiving canakinumab have undergone close monitoring for infections. Compared to placebo canakinumab associates with mildly increased rates of infection, although these have generally been mild to moderate in severety, seldom serious, and either resolved spontaneously or with standard therapy. Nonetheless, all individuals with a history of or at high risk for either tuberculosis or HIV related disease will not be eligible for CANTOS, nor will any individuals with chronic infections or the need for other systemic anti-inflammatory therapies. Drug-induced autoimmune syndromes, observed with other anti-cytokine agents and caused by potential immune modulation, have not been observed with canakinumab. To date, antibodies to canakinumab (immunogenicity) have not been detected.
