Long-term Safety of Tocilizumab: Results from 3 Years of Followup Postmarketing Surveillance of 5573 Patients with Rheumatoid Arthritis in Japan
Kazuhiko Yamamoto, Hajime Goto, Kenzo Hirao, Atsuo Nakajima, Hideki Origasa, Kunihiko Tanaka, Minako Tomobe and Kyoichi Totsuka. - The Journal of Rheumatology. 1 June 2015 DOI: 10.3899/jrheum.141210 [Epub ahead of print]
The humanised anti-interleukin 6 receptor monoclonal antibody tocilizumab (TCZ) has been available in clinical practice for several years. The purpose of this study was to evaluate the long-term safety of for the treatment of RA in a real-world clinical setting as a long-term extension of a single-arm, observational post marketing surveillance study. Data on selected adverse events (AEs) - fatal events, serious infection, malignancy, GI perforation, and serious cardiac dysfunction - were collected from 5573 patients.
Findings from this study show a consistent safety profile for TCZ over time for the selected AEs, confirming the long-term safety of TCZ use in patients with RA in a real-world clinical setting.