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|dc.identifier.citation||Modern Rheumatology, Jul 2014, 24(4), P.572-579||en_US|
|dc.description.abstract||Objective. To compare the incidence and risk factors of serious adverse events (SAEs) in rheumatoid arthritis (RA) patients treated with etanercept (ETN) or adalimumab (ADA) between Korean and Japanese registries. Methods. We recruited 416 RA patients [505.2 patient-years (PYs)] who started ETN or ADA from Korean registry and 537 RA patients (762.0 PY) from Japanese registry. The patient background, incidence rate (IR) of SAE in 2 years, and risk factors for SAEs were compared. Results. Korean patients were younger and used more nonbiologic DMARDs, higher doses of methotrexate, and lower doses of prednisolone (PSL). The IR of SAEs (/100 PY) was higher in the Japanese registry compared to the Korean [13.65 vs. 6.73]. In both registries, infection was the most frequently reported SAE. The only significant risk factor for SAEs in Korean registry was age by decade [1.45]. In Japanese registry, age by decade [1.54], previous use of nonbiologic DMARDs >= 4 [1.93], and concomitant use of oral PSL >= 5 mg/day [2.20] were identified as risk factors for SAEs. Conclusions. The IR of SAE in Japan, especially infection, was higher than that of Korea, which was attributed to the difference of demographic and clinical characteristics of RA patients and treatment profiles.||en_US|
|dc.description.sponsorship||This work was supported by a grant from the Korea Healthcare TechnologyR & D Project, Ministry of Health and Welfare, Republic of Korea(A102065). This work was supported by the National Research Foundationof Korea Grant funded by the Korean Government (Ministry of Education,Science and Technology) (NRF357-2011-1-E00037). This work was supportedby a grant-in-aid from the Ministry of Health, Labor and Welfare,Japan (H23-meneki-sitei-016 and H19-meneki-ippan-009 to N. Miyasaka,H22-meneki-ippann-001 to M. Harigai) and by a grant-in-aid for scientifi cresearch from the Japan Society for the Promotion of Science (#20390158to M. Harigai, #19590530 to R. Koike, and #50277141 to M. Tanaka).This work was also supported by grants for pharmacovigilance researchon biologics from Abbott Laboratories, Bristol-Myers Japan, Eisai Co.Ltd., Chugai Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corp.,Takeda Pharmaceutical Co. Ltd., and Pfi zer Japan Inc. (to M. Harigai),and by a grant from the Japanese Ministry of Education, GCOE Program,“ International Research Center for Molecular Science in Tooth and BoneDiseases ” (to N. Miyasaka)||en_US|
|dc.title||A comparison of incidence and risk factors for serious adverse events in rheumatoid arthritis patients with etanercept or adalimumab in Korea and Japan||en_US|
|dc.sector.daehak||COLLEGE OF MEDICINE[S]||-|
|dc.sector.department||DEPARTMENT OF MEDICINE||-|
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