Canakinumab, Ilaris, ACZ885 : (IL-1b) - Juvenile Arthritis, RA, other inflammatory diseases


Monoclonal antibody
TypeWhole antibody
Clinical data
Trade namesIlaris
AHFS/Drugs.comConsumer Drug Information
License data
Routes of
intravenous, subcutaneous
ATC code
Legal status
Legal status
CAS Number
  • none
Chemical and physical data
Molar mass145.2 kg/mol
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Canakinumab (INN, trade name Ilaris, previously ACZ885)[2] is a human monoclonal antibody targeted at interleukin-1 beta. It has no cross-reactivity with other members of the interleukin-1 family, including interleukin-1 alpha.[3]
Canakinumab was approved for the treatment of cryopyrin-associated periodic syndromes (CAPS) by the U.S. Food and Drug Administration (FDA) in June 2009[4] and by the European Medicines Agency in October 2009.[5] CAPS is a spectrum of autoinflammatory syndromes including familial cold autoinflammatory syndrome, Muckle–Wells syndrome, and neonatal-onset multisystem inflammatory disease. In September 2016, FDA approved the use of canakinumab on 3 additional rare and serious auto-inflammatory diseases:[6] Tumor necrosis factor receptor associated periodic syndrome (TRAPS), Hyperimmunoglobulin D syndrome (HIDS)/Mevalonate kinase deficiency (MKD) and Familial Mediterranean fever (FMF).
Canakinumab was being developed by Novartis for the treatment of rheumatoid arthritis, but this trial was completed in October 2009.[7] Canakinumab is also in phase I clinical trials as a possible treatment for chronic obstructive pulmonary disease,[8] gout and coronary artery disease (the CANTOS trial;[9]). It is also in trials for schizophrenia.[10] In gout it may result in better outcomes than a low dose of a steroid but costs five thousand times more.[11]
On Aug 27, 2017, the results of the CANTOS trial were announced at the European Society of Cardiology and published Lancet and the New England Journal of Medicine.[12] CANTOS saw a 15% reduction in deaths from heart attacks, stroke and cardiovascular disease combined. CANTOS also observed serious side-effects, and no statistically significant overall survival benefit. Nonetheless, David Goff, director of the division of cardiovascular sciences at the National Heart, Lung and Blood Institute feels the "public health impact potential is really substantial,” and estimates that in the United States 3 million people might benefit from canakinumab.[12] Further analysis on data from the CANTOS trial also showed a significant reduction in lung cancer incidence and mortality in the canakinumab treated group compared to placebo.