title: Safety of infliximab therapy in rheumatoid arthritis patients with previous exposure to hepatitis B virus.
abstract: OBJECTIVE
  To evaluate the safety of tumor necrosis factor-α (TNF-α) monoclonal antibody (infliximab) therapy in patients with rheumatoid arthritis (RA) and previous exposure to hepatitis B virus (HBV) who had normal liver function.
  
  
  METHODS
  This is a retrospective study from a 26-week, prospective, multicenter trial in 234 patients with RA who received infusions of infliximab (3 mg/kg at week 0, 2, 6, 14 and 22). The medical records of these patients were reviewed, including the information on disease duration, laboratory tests and HBV markers. The data on liver function during the study was analyzed, as well as comparison between patients with previous exposure to HBV and patients without such exposure.
  
  
  RESULTS
  Forty-one patients with previous exposure to HBV were HBsAg(-). Forty patients had normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and only one patient with positive anti-HBc showed an elevated ALT level before administration of infliximab, and had a further increase of ALT level at week 14, but decreased thereafter. The average ALT and AST levels rose slightly during the treatment but remained in normal range and the differences were insignificant compared with baseline. There was no statistically significant difference in the incidence of liver function abnormalities during the treatment of infliximab between the patients with previous exposure to HBV and those without such exposure.
  
  
  CONCLUSIONS
  In patients with RA and previous exposure to HBV but with a negative HBsAg and normal liver function at baseline, liver function abnormalities were not observed during infliximab treatment.
authors.affiliation: Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China.
authors.forename: Xuewu
authors.initials: X
authors.lastname: Zhang
authors.forename: Fengchun
authors.initials: F
authors.lastname: Zhang
authors.forename: Donghai
authors.initials: D
authors.lastname: Wu
authors.forename: Chunde
authors.initials: C
authors.lastname: Bao
authors.forename: Ping
authors.initials: P
authors.lastname: Zhu
authors.forename: Xiao
authors.initials: X
authors.lastname: Zhang
authors.forename: Cibo
authors.initials: C
authors.lastname: Huang
authors.forename: Dongyi
authors.initials: D
authors.lastname: He
authors.forename: Yi
authors.initials: Y
authors.lastname: Tao
authors.forename: Yongfei
authors.initials: Y
authors.lastname: Fang
authors.forename: Jieruo
authors.initials: J
authors.lastname: Gu
authors.forename: Huaxiang
authors.initials: H
authors.lastname: Wu
authors.forename: Lingyun
authors.initials: L
authors.lastname: Sun
authors.forename: Xiuyan
authors.initials: X
authors.lastname: Yang
authors.forename: Feng
authors.initials: F
authors.lastname: Huang
authors.forename: Huji
authors.initials: H
authors.lastname: Xu
authors.forename: Dongbao
authors.initials: D
authors.lastname: Zhao
authors.forename: Miaojia
authors.initials: M
authors.lastname: Zhang
authors.forename: Yi
authors.initials: Y
authors.lastname: Zheng
authors.forename: Zhanguo
authors.initials: Z
authors.lastname: Li
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000453:epidemiology*; D015897:Comorbidity; D005260:Female; D006509:Hepatitis B / Q000453:epidemiology*; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006515:Hepatitis B virus; D006801:Humans; D000069285:Infliximab; D007668:Kidney / Q000502:physiology; D008099:Liver / Q000201:enzymology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012189:Retrospective Studies; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D006514:Hepatitis B Surface Antigens; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab
keywords: HBV infection; infliximab; rheumatoid arthritis