Safety of infliximab therapy in rheumatoid arthritis patients with previous exposure to hepatitis B virus.
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.


CONCLUSION
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.
['Zhang|Xuewu|X|', 'Zhang|Fengchun|F|', 'Wu|Donghai|D|', 'Bao|Chunde|C|', 'Zhu|Ping|P|', 'Zhang|Xiao|X|', 'Huang|Cibo|C|', 'He|Dongyi|D|', 'Tao|Yi|Y|', 'Fang|Yongfei|Y|', 'Gu|Jieruo|J|', 'Wu|Huaxiang|H|', 'Sun|Lingyun|L|', 'Yang|Xiuyan|X|', 'Huang|Feng|F|', 'Xu|Huji|H|', 'Zhao|Dongbao|D|', 'Zhang|Miaojia|M|', 'Zheng|Yi|Y|', 'Li|Zhanguo|Z|']
D000328:Adult D000911:Antibodies, Monoclonal D018501:Antirheumatic Agents D001172:Arthritis, Rheumatoid D015897:Comorbidity D005260:Female D006509:Hepatitis B D006514:Hepatitis B Surface Antigens D006515:Hepatitis B virus D006801:Humans D000069285:Infliximab D007668:Kidney D008099:Liver D008297:Male D008875:Middle Aged D011446:Prospective Studies D012189:Retrospective Studies D016896:Treatment Outcome D014409:Tumor Necrosis Factor-alpha
infliximab rheumatoid arthritis HBV infection