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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

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
Author
조수경
Keywords
INTERLEUKIN-6 RECEPTOR INHIBITION; MODIFYING ANTIRHEUMATIC DRUGS; PLACEBO-CONTROLLED TRIAL; SERIOUS INFECTION; DOUBLE-BLIND; POSTMARKETING SURVEILLANCE; INADEQUATE RESPONSE; EULAR RECOMMENDATIONS; CONSENSUS STATEMENT; TREATMENT OPTIONS
Issue Date
2015-03
Publisher
BIOMED CENTRAL LTD
Citation
ARTHRITIS RESEARCH & THERAPY, v. 17, Page. 74-83
Abstract
Introduction: 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. Methods: 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. Results: 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). Conclusions: 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.
URI
http://arthritis-research.biomedcentral.com/articles/10.1186/s13075-015-0583-8http://hdl.handle.net/20.500.11754/23449
ISSN
1478-6354; 1478-6362
DOI
10.1186/s13075-015-0583-8
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COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
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