Use of Tumor Necrosis Factor-α Antagonists in Patients with Concurrent Rheumatoid Arthritis or Spondyloarthritis and Hepatitis B

Objective: To assess the safety of biological agents in patients with rheumatic diseases associated with hepatitis B in one medical center.Methods: Patients who had taken etanercept or adalimumab from January 2002 to September 2010 in Chung Shan Medical University Hospital were reviewed in the study. We retrospectively investigated a series of serum aminotransferase (ALT) levels, hepatitis serologic status including HBV surface antigen (HBsAg), HBV surface antibody (HBsAb), HBV core IgG Ab (HBcAb), and HBV-DNA. Endpoints were clinical reactivation and subclinical reactivation as defined by ALT and viral load, respectively.Results: A total of 161 patients were documented to have taken etanercept or adalimumab. Among the 161 patients, 17 (10.56%) patients had chronic hepatitis B (HbsAg+) without anti-viral agent prophylaxis prior to biologics. Nine patients were excluded from the analysis due to missing data. Of these remaining 8 patients, only 1 (12.5%) patient had transient mild clinical reactivation after taking etanercept for 4 months. Spontaneous remission of this patient’s HBV reactivation was noted without anti-viral therapy.Conclusion: All rheumatic patients who plan to take biologics treatment should undergo tests for HBV, and they should have a close follow-up with ALT during therapy. Preemptive anti-viral therapy is commenced in patients who develop evidence of disease reactivation. For chronic hepatitis patients, it might not be necessary to use a prophylactic anti-viral agent prior to biologics.