title: A comparison of incidence and risk factors for serious adverse events in rheumatoid arthritis patients with etanercept or adalimumab in Korea and Japan.
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.
authors: Department of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University , Tokyo , Japan.
authors: Soo-Kyung
authors: SK
authors: Cho
authors: Ryoko
authors: R
authors: Sakai
authors: Toshihiro
authors: T
authors: Nanki
authors: Ryuji
authors: R
authors: Koike
authors: Kaori
authors: K
authors: Watanabe
authors: Hayato
authors: H
authors: Yamazaki
authors: Hayato
authors: H
authors: Nagasawa
authors: Yoshiya
authors: Y
authors: Tanaka
authors: Atsuo
authors: A
authors: Nakajima
authors: Shinsuke
authors: S
authors: Yasuda
authors: Atsushi
authors: A
authors: Ihata
authors: Kazuhiko
authors: K
authors: Ezawa
authors: Soyoung
authors: S
authors: Won
authors: Chan-Bum
authors: CB
authors: Choi
authors: Yoon-Kyoung
authors: YK
authors: Sung
authors: Tae-Hwan
authors: TH
authors: Kim
authors: Jae-Bum
authors: JB
authors: Jun
authors: Dae-Hyun
authors: DH
authors: Yoo
authors: Nobuyuki
authors: N
authors: Miyasaka
authors: Sang-Cheol
authors: SC
authors: Bae
authors: Masayoshi
authors: M
authors: Harigai
mesh_terms: D000068879:Adalimumab; D000367:Age Factors; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects* / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects* / Q000627:therapeutic use; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use; D012042:Registries; D056910:Republic of Korea / Q000453:epidemiology; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068879:Adalimumab; D000068800:Etanercept
keywords: Epidemiology; Registry; Rheumatoid arthritis; Safety