title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Giannitti
authors.affiliation: Interdisciplinary Department of Medicine, Rheumatology Unit, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lopalco
authors.affiliation: Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Vitale
authors.affiliation: Institute of Paediatrics, Università Cattolica Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli, Rome, Italy.
authors.forename: Donato
authors.initials: D
authors.lastname: Rigante
authors.affiliation: Interdisciplinary Department of Medicine, Rheumatology Unit, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Anelli
authors.affiliation: Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Fabbroni
authors.affiliation: Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Manganelli
authors.affiliation: Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Galeazzi
authors.affiliation: Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Frediani
authors.affiliation: Section of Gastroenterology, Department of Emergency and Organ Transplantation, AOU Policlinico, University of Bari, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Barone
authors.affiliation: Interdisciplinary Department of Medicine, Rheumatology Unit, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lapadula
authors.affiliation: Interdisciplinary Department of Medicine, Rheumatology Unit, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Florenzo
authors.initials: F
authors.lastname: Iannone
authors.affiliation: Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Italy. cantariniluca@hotmail.com.
authors.forename: Luca
authors.initials: L
authors.lastname: Cantarini
mesh_terms: D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D018501:Antirheumatic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001688:Biological Products / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006509:Hepatitis B / Q000097:blood / Q000150:complications*; D006801:Humans; D008099:Liver / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D025241:Spondylarthritis / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D014775:Virus Activation / Q000187:drug effects
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products; D014409:Tumor Necrosis Factor-alpha; D000410:Alanine Transaminase