European and Asian studies report conflicting data on the risk of hepatitis B virus (HBV) reactivation in rheumatologic patients with a previously resolved HBV (prHBV)
infection undergoing long-term
biologic therapies. In this patient category, the safety of different immunosuppressive
biologic therapies, including
rituximab, was assessed. A total of 1218 Caucasian rheumatologic patients, admitted consecutively as outpatients between 2001 and 2012 and taking
biologic therapies, underwent evaluation of anti-HCV and HBV markers as well as liver amino
transferases every 3 months. Starting from January 2009, HBV
DNA monitoring was performed in patients with a prHBV
infection who had started immunosuppressive
biologic therapy both before and after 2009. Patients were considered to have elevated
aminotransferase levels if values were >1× upper normal limit at least once during follow-up. We found 179 patients with a prHBV
infection (14 treated with
rituximab, 146 with anti-
tumor necrosis factor-alpha, and 19 with other
biologic therapies) and 959 patients without a prHBV
infection or other
liver disease (controls). The mean age in the former group was significantly higher than the controls. Patients with a prHBV
infection never showed detectable HBV
DNA serum levels or antibody to
hepatitis B surface antigen/
hepatitis B surface antigen seroreversion. However, when the prevalence of elevated amino
transferases in patients with prHBV
infection was compared to controls, it was significantly higher in the former group only for
aminotransferase levels >1× upper normal limit but not when
aminotransferase levels >2× upper normal limit were considered.
CONCLUSION: Among patients with a prHBV
infection and rheumatologic indications for long-term
biologic therapies, HBV reactivation was not seen; this suggests that universal prophylaxis is not justified and is not cost-effective in this clinical setting.