Background/Purpose: Reactivation of hepatitis B virus (HBV) is very problematic in patients who are receiving biologics. Optimal precaution and management for those patients are still controversial. The aim of this study is to clarify the incidence of HBV reactivation in rheumatoid arthritis (RA) patients on biologics and to find out whether there is difference in reactivation rates among different biologics.

Methods: Retrospective observational study. HBV reactivation was defined as conversion from quantitative negativity to qualitative positivity of HBV-DNA in sera. All the patients with RA who were treated with biologics from July 2010 to December 2012 were tested for HBsAg, anti-HBs and anti-HBc. If the patients were positive for HBsAg, or negative for HBsAg but positive for anti-HBs and/or anti-HBc, ALT and AST were also retrieved from patients’ records. HBsAg, anti-HBs and anti-HBc were examined using chemiluminescent immunoassay, and the levels of HBV-DNA were measured by real-time PCR (lowest detection limit was 2.1 log copies/ml). The ethics committee of our hospital approved this study.

Results: Among 247 patients received biologics, none was found positive for HBsAg. 57 patients (23.0%) were negative for HBsAg but positive for anti-HBs and/or anti-HBc. These patients were considered to have resolved HBV infection. Infliximab, etanarcept, adalimumab, tocilizumab and abatacept were used in 27, 25, 17, 18 and one, respectively; some of the patients received multiple biologics. HBV-DNA became positive in 4 patients (7.0%): 1 while on etanercept, 1 while on infliximab, and 2 while on tocilizumab. However, the levels of HBV-DNA were below the quantitative detection limits in these 4 patients. In one patient on tocilizumab, HBV-DNA levels fluctuated between positive and negative ranges for 4 months; first HBV-DNA positivity was found at 2 months after tocilizumab-use. In another case on tocilizumab, HBV-DNA was first found at 2 months after tocilizumab-use, persisted for 3 months, and disappeared thereafter. In one patient on infliximab, HBV-DNA became positive only once at 22 months after infliximab-use. In one patient on etanercept, HBV-DNA was found only once at 17 months after etanercept-use. Liver function tests were within normal ranges in all examinations from all the patients. All the patients continued treatment with the biologics and HBV-DNA became negative eventually without anti-viral treatment.

Conclusion: HBV reactivation was observed in 7.0% of RA patients with resolved HBV infection during treatment with biologics. However, HBV-DNA levels were below the quantitative detection limits and liver function tests were normal throughout. There were no differences among biologics in regards to the incidence of HBV reactivation. Anti-TNFs and anti-IL-6 receptor antibody may be used safely in RA patients with a history of HBV infection.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/incidence-of-hepatitis-b-virus-reactivation-in-patients-with-rheumatoid-arthritis-during-treatment-with-biologics/