Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 조수경 | - |
dc.date.accessioned | 2016-09-26T07:13:36Z | - |
dc.date.available | 2016-09-26T07:13:36Z | - |
dc.date.issued | 2015-03 | - |
dc.identifier.citation | ARTHRITIS RESEARCH & THERAPY, v. 17, Page. 74-83 | en_US |
dc.identifier.issn | 1478-6354 | - |
dc.identifier.issn | 1478-6362 | - |
dc.identifier.uri | http://arthritis-research.biomedcentral.com/articles/10.1186/s13075-015-0583-8 | - |
dc.identifier.uri | http://hdl.handle.net/20.500.11754/23449 | - |
dc.description.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. | en_US |
dc.description.sponsorship | This work was supported by a grant-in-aid from the Ministry of Health, Labor and Welfare, Japan (H19-meneki-ippan-009 to N. Miyasaka, H22-menekiippann-001 to M. Harigai) and by a grant-in-aid for scientific research from the Japan Society for the Promotion of Science (#20390158 to M. Harigai, #19590530 to R. Koike). This work was also supported by grants for pharmacovigilance research on biologics from Abbvie Laboratories, Astellas Pharma Inc., Bristol-Myers Japan, Eisai Co. Ltd., Chugai Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corp., Takeda Pharmaceutical Co. Ltd., UCB Japan and Pfizer Japan Inc. (to M. Harigai), and by a grant from the Japanese Ministry of Education, Global Center of Excellence (GCOE) Program, 'International Research Center for Molecular Science in Tooth and Bone Diseases.' | en_US |
dc.language.iso | en | en_US |
dc.publisher | BIOMED CENTRAL LTD | en_US |
dc.subject | INTERLEUKIN-6 RECEPTOR INHIBITION | en_US |
dc.subject | MODIFYING ANTIRHEUMATIC DRUGS | en_US |
dc.subject | PLACEBO-CONTROLLED TRIAL | en_US |
dc.subject | SERIOUS INFECTION | en_US |
dc.subject | DOUBLE-BLIND | en_US |
dc.subject | POSTMARKETING SURVEILLANCE | en_US |
dc.subject | INADEQUATE RESPONSE | en_US |
dc.subject | EULAR RECOMMENDATIONS | en_US |
dc.subject | CONSENSUS STATEMENT | en_US |
dc.subject | TREATMENT OPTIONS | en_US |
dc.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 | en_US |
dc.type | Article | en_US |
dc.relation.volume | 17 | - |
dc.identifier.doi | 10.1186/s13075-015-0583-8 | - |
dc.relation.page | 74-83 | - |
dc.relation.journal | ARTHRITIS RESEARCH & THERAPY | - |
dc.contributor.googleauthor | Sakai, Ryoko | - |
dc.contributor.googleauthor | Cho, Soo-Kyung | - |
dc.contributor.googleauthor | Nanki, Toshihiro | - |
dc.contributor.googleauthor | Watanabe, Kaori | - |
dc.contributor.googleauthor | Yamazaki, Hayato | - |
dc.contributor.googleauthor | Tanaka, Michi | - |
dc.contributor.googleauthor | Koike, Ryuji | - |
dc.contributor.googleauthor | Tanaka, Yoshiya | - |
dc.contributor.googleauthor | Saito, Kazuyoshi | - |
dc.contributor.googleauthor | Hirata, Shintaro | - |
dc.relation.code | 2015002075 | - |
dc.sector.campus | S | - |
dc.sector.daehak | COLLEGE OF MEDICINE[S] | - |
dc.sector.department | DEPARTMENT OF MEDICINE | - |
dc.identifier.pid | skchomd | - |
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