Background Canakinumab (CAN), a fully human, selective, anti-interleukin (IL)-1β monoclonal antibody, is approved for the treatment of CAPS, an extremely rare autoinflammatory disorder associated with overproduction of IL-1β, including the subtypes familial cold autoinflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS), and neonatal-onset multisystem inflammatory disease/chronic infantile neurological cutaneous and articular syndrome (NOMID/CINCA). Here we present updated safety data for CAN in CAPS patients (pts) from the ongoing β-Confident Registry.
Objectives To monitor and further explore the overall safety of CAN, focusing primarily on serious infections, malignancies, hypersensitivity reactions, vertigo, and other selected events in CAPS pts over a 5-year period.
Methods CAPS pts receiving CAN as part of their routine medical care are included in the Registry. Safety data are collected during routine clinical assessments (no mandatory visits or procedures), and include selected adverse events (AEs), which are (1) all cases of infections (serious), malignancies, hypersensitivity reactions, vertigo, (2) all serious AEs (SAEs), and (3) all AEs reported as related to CAN. Cumulative safety data are reported here from the date of first patient enrolled (November 19, 2009) through the data cut-off date (September 6, 2012). Additional safety data will be updated with the poster presentation, as available.
Results A total of 234 pts were enrolled since November 2009 (Table), of whom 65 (27.8%) reported 136 AEs with an incidence rate of 101.0/100 patient years. Infection was the most common AE (45 events) reported in 31(13.2%) pts with an incidence rate of 33.4/100 patient years. Nasopharyngitis, pneumonia and urinary tract infections were the most common infections reported. Five pts, with no prior history of vertigo, experienced one or more episodes of vertigo, none of which were SAEs. Twenty SAEs with an incidence rate of 14.9/100 patient years were reported in 13 (5.6%) pts, including 1 fatal case of malignancy (metastatic rectal adenocarcinoma in a 76 yo MWS patient). Five serious infections were reported (pneumonia in 3 MWS pts; sterile meningitis and erysipelas due to vaccination respectively in 2 NOMID pts), which were completely resolved or improved with treatment. None of the infections were reported to be opportunistic. No hypersensitivity reactions to CAN were reported. Seven permanent CAN discontinuations were reported; 3 due to AEs, 2 due to patient preference and 2 due to lack of a therapeutic effect.
Conclusions As expected with CAN, infection was the most commonly reported AE and SAE. No new or unexpected safety signals were identified in this ongoing Registry.
Disclosure of Interest J. B. Kuemmerle-Deschner Grant/research support from: Novartis, Consultant for: Novartis, H. Tilson Shareholder of: Glaxo SmithKline, Procter & Gamble, Other non-pharmaceutical holdings, Consultant for: Bio Soteria, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, HealthCore, Kendle, Merck, Novartis, P. N. Hawkins: None Declared, T. van der Poll Consultant for: Novartis, U. A. Walker Consultant for: Novartis, B. Rauer Employee of: Novartis Pharma AG, J. M. Nebesky Employee of: Novartis Pharma AG, D. Kim Employee of: Novartis Pharmaceuticals Corporation, N. Davis Employee of: Novartis Pharmaceuticals Corporation, H. Hoffman Consultant for: Novartis, Regeneron, Sobi Biovitrum