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Reactivation of hepatitis B virus infection in patients with rheumatoid arthritis receiving tofacitinib: a real-world study
  1. Yi-Ming Chen1,2,3,4,
  2. Wen-Nan Huang1,2,
  3. Yi-Da Wu1,
  4. Ching-Tsai Lin1,
  5. Yi-Hsing Chen1,2,
  6. Der-Yuan Chen1,2,3,4,5,
  7. Tsu-Yi Hsieh1,6
  1. 1 Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital, Taichung, Taiwan
  2. 2 Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan
  3. 3 Institute of Biomedical Science, National Chung Hsing University, Taichung, Taiwan
  4. 4 Rong Hsing Research Center for Translational Medicine, National Chung Hsing University, Taichung, Taiwan
  5. 5 Institute of Microbiology and Immunology, Chung Shan Medical University, Taichung, Taiwan
  6. 6 Ph D Program of Business, College of Business, Feng Chia University, Taichung, Taiwan
  1. Correspondence to Dr Tsu-Yi Hsieh, Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital, No. 1650, Sec. 4, Taiwan Boulevard, Taichung 40705, Taiwan; zuyihsieh{at}

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A recent study reported long-term safety outcomes of tofacitinib for rheumatoid arthritis (RA) in global clinical trials1; the safety profile of tofacitinib exposure through 8.5 years appeared stable over time, with no new detectable safety signals. However, since most tofacitinib studies excluded patients with chronic hepatitis B (HBV) infection,1 2 the risk of HBV reactivation among tofacitinib-treated patients remains unknown.

More than two billion people globally have been infected by HBV,3 and a substantial number of patients with RA outside North America and Western Europe have coexisting HBV infection.4 HBV reactivation is a critical challenge in patients with RA receiving biological therapy5; consequently, HBV screening is recommended before initiating biologics.3 Janus kinase inhibition may counteract the suppressive effects of interferon α on viral replication6; therefore, we assessed the risk of HBV reactivation in patients receiving tofacitinib.

We established a retrospective cohort of 116 Taiwanese patients with RA who received tofacitinib at a single medical centre between April 2015 …

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  • Contributors All authors made substantial intellectual contributions to conception of the work, the interpretation of data and approval of the final manuscript. T-YH and Y-MC conceived of the study, generated the original hypothesis, designed the study, and drafted and revised the manuscript. W-NH, Y-DW, C-TL and Y-HC acquired clinical data and analysed data. D-YC conceived of the study, analysed data and revised the manuscript.

  • Funding This study was supported by a grant from Taichung Veterans General Hospital, Taiwan (TCVGH-1057309C).

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval Institution Review Board of Taichung Veterans General Hospital.

  • Provenance and peer review Not commissioned; externally peer reviewed.