Title |
Head-to-head comparison of the safety of tocilizumab and tumor necrosis factor inhibitors in rheumatoid arthritis patients (RA) in clinical practice: results from the registry of Japanese RA patients on biologics for long-term safety (REAL) registry
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Published in |
Arthritis Research & Therapy, March 2015
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DOI | 10.1186/s13075-015-0583-8 |
Pubmed ID | |
Authors |
Ryoko Sakai, Soo-Kyung Cho, Toshihiro Nanki, Kaori Watanabe, Hayato Yamazaki, Michi Tanaka, Ryuji Koike, Yoshiya Tanaka, Kazuyoshi Saito, Shintaro Hirata, Koichi Amano, Hayato Nagasawa, Takayuki Sumida, Taichi Hayashi, Takahiko Sugihara, Hiroaki Dobashi, Shinsuke Yasuda, Tetsuji Sawada, Kazuhiko Ezawa, Atsuhisa Ueda, Takao Fujii, Kiyoshi Migita, Nobuyuki Miyasaka, Masayoshi Harigai, for the REAL Study Group |
Abstract |
The objective of this study was to directly compare the safety of tocilizumab (TCZ) and TNF inhibitors (TNFIs) in rheumatoid arthritis (RA) patients in clinical practice. This prospective cohort study included RA patients starting TCZ [TCZ group, n = 302, 224.68 patient-years (PY)] or TNFIs [TNFI group, n = 304, 231.01 PY] from 2008 to 2011 in the registry of Japanese RA patients on biologics for long-term safety registry. We assessed types and incidence rates (IRs) of serious adverse events (SAEs) and serious infections (SIs) during the first year of treatment. Risks of the biologics for SAEs or SIs were calculated using the Cox regression hazard analysis. Patients in the TCZ group had longer disease duration (P <0.001), higher disease activity (P = 0.019) and more frequently used concomitant corticosteroids (P <0.001) than those in the TNFI group. The crude IR (/100 PY) of SIs [TCZ 10.68 vs. TNFI 3.03; IR ratio (95% confidence interval [CI]), 3.53 (1.52 to 8.18)], but not SAEs [21.36 vs. 14.72; 1.45 (0.94 to 2.25)], was significantly higher in the TCZ group compared with the TNFI group. However, after adjusting for covariates using the Cox regression hazard analysis, treatment with TCZ was not associated with higher risk for SAEs [hazard ratio (HR) 1.28, 95% CI 0.75 to 2.19] or SIs (HR 2.23, 95% CI 0.93 to 5.37). The adjusted risks for SAEs and SIs were not significantly different between TCZ and TNFIs, indicating an influence of clinical characteristics of the patients on the safety profile of the biologics in clinical practice. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 1 | 100% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Practitioners (doctors, other healthcare professionals) | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 1 | 1% |
Unknown | 90 | 99% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 17 | 19% |
Student > Ph. D. Student | 10 | 11% |
Professor | 8 | 9% |
Student > Doctoral Student | 7 | 8% |
Researcher | 7 | 8% |
Other | 19 | 21% |
Unknown | 23 | 25% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 39 | 43% |
Pharmacology, Toxicology and Pharmaceutical Science | 5 | 5% |
Biochemistry, Genetics and Molecular Biology | 4 | 4% |
Immunology and Microbiology | 4 | 4% |
Computer Science | 2 | 2% |
Other | 11 | 12% |
Unknown | 26 | 29% |