Background Although the reactivation of hepatitis B virus (HBV) is recognised as a serious complication in patients with rheumatic disease (RD) receiving immunosuppressive drugs (ISDs), the incidence and risk factors for reactivation remain controversial.
Objectives To investigate the incidence and risk factors for HBV reactivation in patients with RD.
Methods We performed a multicentre, observational, prospective study over 2 years in patients with resolved HBV infection. Patients with RD treated with a dose of ≥5 mg/day prednisolone and/or synthetic or biological ISDs with negative HB virus surface antigen and positive anti-HB virus surface antibody (HBsAb) and/or anti-HB virus core antibody (HBcAb) were enrolled. Quantitative HBV DNA results and related data were regularly recorded.
Results Among 1042 patients, including 959 with rheumatoid arthritis, HBV DNA was detected in 35 (1.93/100 person-years), with >2.1 log copies/mL observed in 10 patients (0.55/100 person-years). None of the reactivated patients, including seven treated with a nucleic acid analogue, showed overt hepatitis. Low HBsAb titres and advanced age seemed to be risk factors for HBV reactivation; however, reactivation was observed in three patients with positive HBsAb and negative HBcAb test results. The risk of reactivation was lower with methotrexate but higher with prednisolone among the different types of ISDs. The intervals from the start of ISD to reactivation were relatively long (3–182 months; median, 66 months).
Conclusions The incidence of HBV reactivation with ISD use was 1.93/100 person-years in patients with RD with resolved HBV infection. No overt hepatitis was observed in the reactivated patients.
- Rheumatoid Arthritis
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Handling editor Tore K Kvien
Contributors Munetoshi Nakashima, Toshihisa Kanamono, Rika Okada, Ryo Takahashi, Masahito Sato, Kosaku Murakami, Akiko Yoshida, Aki Sakashita and Masatoshi Kadoya contributed for enrolment of patients and Ms Tamaki Ota contributed for data processing in this work.
Funding Ministry of Health Labour and Welfare in Japan (15ek0410004h0003).
Competing interests None declared.
Ethic approvals Japanese Red Cross Kyoto Daiichi Hospital. The hospital ethics committees of all contributing institutions approved the protocol for this study.
Provenance and peer review Not commissioned; externally peer reviewed.
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