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Long-term safety of anti-TNF agents on the liver of patients with spondyloarthritis and potential occult hepatitis B viral infection: an observational multicentre study

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13

 

  1. Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.
  2. Interdisciplinary Department of Medicine, Rheumatology Unit, University of Bari Aldo Moro, Bari, Italy.
  3. Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.
  4. Institute of Paediatrics, Università Cattolica Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli, Rome, Italy.
  5. Interdisciplinary Department of Medicine, Rheumatology Unit, University of Bari Aldo Moro, Bari, Italy.
  6. Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.
  7. Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.
  8. Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.
  9. Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.
  10. Section of Gastroenterology, Department of Emergency and Organ Transplantation, AOU Policlinico, University of Bari, Italy.
  11. Interdisciplinary Department of Medicine, Rheumatology Unit, University of Bari Aldo Moro, Bari, Italy.
  12. Interdisciplinary Department of Medicine, Rheumatology Unit, University of Bari Aldo Moro, Bari, Italy.
  13. Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy. cantariniluca@hotmail.com

CER9400
2017 Vol.35, N°1
PI 0093, PF 0097
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PMID: 27974094 [PubMed]

Received: 05/03/2016
Accepted : 11/07/2016
In Press: 09/12/2016
Published: 26/01/2017

Abstract

OBJECTIVES:
The aim of the study was to retrospectively evaluate the long-term safety profile of anti-tumour necrosis factor (TNF)-α agents on the liver of patients with spondyloarthritis (SpA) and a previously resolved hepatitis B virus (HBV) infection.
METHODS:
Medical records from 992 consecutive outpatients receiving anti-TNF-α therapy between 2007 and 2015 were retrospectively reviewed. HBV infection was assessed evaluating HBV surface antigen (HBsAg), antibodies to HBsAg (anti-HBs), antibodies to hepatitis B core (anti-HBc), and HBV-DNA levels. In patients with a previously resolved HBV infection, serum levels of aminotransferase (AST/ALT) were also assessed every three months, while HBsAg and HBV-DNA every six months.
RESULTS:
We identified 131 consecutive patients (70 males, 61 females) with SpA and resolved HBV infection. At baseline none of the patients were positive for HBV-DNA, and AST/ALT levels were within the normal range with no subsequent increase during the observational treatment period. None received antiviral therapy prior to or during anti-TNF drug administration. At the end of the follow-up period (75.50±33.37 months) no viral reactivation was observed in anti-HBc positive patients, regardless of anti-HBs positivity. During the whole follow-up, HBV-DNA was undetectable in all patients, HBsAg remained negative, and it was not necessary to discontinue biologic therapy because of liver damage.
CONCLUSIONS:
Our results confirm that pre-emptive antiviral prophylaxis may not be necessary routine, but strict monitoring for AST/ALT levels, as well as for changes in HBV serology and HBV-DNA remain necessary and seem a realistic and cost-effective approach to identify early viral reactivation.

Rheumatology Article