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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
I. Papalopoulos1, A. Fanouriakis2, N. Kougkas3, I. Flouri4, G. Sourvinos5, G. Bertsias6, A. Repa7, N. Avgoustidis8, P. Sidiropoulos9
- Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.
- 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
- Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.
- Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.
- Rheumatology and Clinical Immunology Unit, 4th Department of Internal Medicine, “Attikon” University Hospital, Athens, Greece.
- Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.
- Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.
- Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.
- Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece.
CER10270
2018 Vol.36, N°1
PI 0102, PF 0109
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PMID: 28850029 [PubMed]
Received: 22/01/2017
Accepted : 29/05/2017
In Press: 28/08/2017
Published: 05/02/2018
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.
