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Liver safety of non-tumour necrosis factor inhibitors in rheumatic patients with past hepatitis B virus infection: an observational, controlled, long-term study

1, 2, 3, 4, 5, 6, 7, 8, 9

  1. Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.
  2. Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion; and Laboratory of Clinical Virology, Medical School, University of Crete, Heraklion, Greece. afanouriakis@edu.med.uoc.gr
  3. Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.
  4. Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.
  5. Rheumatology and Clinical Immunology Unit, 4th Department of Internal Medicine, “Attikon” University Hospital, Athens, Greece.
  6. Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.
  7. Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.
  8. Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.
  9. Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.

CER10270 Submission on line
2018 Vol.36, N°1 - PI 0102, PF 0109
Full Papers

Rheumatology Article

 

Abstract

OBJECTIVES:
The risk of hepatitis B virus (HBV) reactivation with non-tumour necrosis factor inhibitor (non-TNFi) biologic agents in patients with rheumatic diseases and past HBV infection has not been definively elucidated. We assessed the comparative safety of non-TNFi and TNFi biologic agents in such patients in real-life clinical settings. METGODS: We carried out a retrospective cohort study from the Department of Rheumatology, University Hospital of Heraklion. Patients who received abatacept (ABA), tocilizumab (TCZ) or rituximab (RTX) during the period 2003–2016 and were HbsAg(-), anti-HBc(+), anti-HBs(±) at baseline, were monitored for HBV reactivation. Patients treated with TNFi agents during the same period were used as a control group.
RESULTS:
101 cases of non-TNFi (39 ABA, 32 RTX and 30 TCZ) and 111 cases of TNFi treatment were identified. In non-TNFi, 76 cases (75.2%) were anti-HBc(+)/anti-HBs(+) and 25 (24.8%) were anti-HBc(+)/anti-HBs(-), as compared to 82 (73.9%) and 29 (26.1%) in TNFi-treated, respectively. After a median (IQR) observation of 24.0 (34.7) months, two cases (2.0%) of HBV reactivation were identified in the non-TNFi group; one with ABA, successfully treated with entecavir, and one fatal case with RTX and prior exposure to cyclophosphamide. No reactivation was observed in the TNFi group (p=0.226 vs. non-TNFi). Αnti-HBs titres were significantly reduced compared to baseline in the non-TNFi group [median (IQR) 203.9 (954.7) mIU/ml before treatment versus 144.9 (962.9) mIU/ml after treatment, p=0.03].
CONCLUSIONS:
Two cases of HBV reactivation highlight the risk for this complication in patients with past HBV infection under biologic therapy.

PMID: 28850029 [PubMed]

Received: 22/01/2017 - Accepted : 29/05/2017 - In Press: 28/08/2017 - Published: 05/02/2018