PMID- 28850029 OWN - NLM STAT- MEDLINE DCOM- 20180424 LR - 20220317 IS - 0392-856X (Print) IS - 0392-856X (Linking) VI - 36 IP - 1 DP - 2018 Jan-Feb TI - Liver safety of non-tumour necrosis factor inhibitors in rheumatic patients with past hepatitis B virus infection: an observational, controlled, long-term study. PG - 102-109 AB - 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). Alphanti-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. FAU - Papalopoulos, Ioannis AU - Papalopoulos I AD - Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece. FAU - Fanouriakis, Antonis AU - Fanouriakis A AD - 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. FAU - Kougkas, Nikolaos AU - Kougkas N AD - Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece. FAU - Flouri, Irini AU - Flouri I AD - Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece. FAU - Sourvinos, George AU - Sourvinos G AD - Rheumatology and Clinical Immunology Unit, 4th Department of Internal Medicine, "Attikon" University Hospital, Athens, Greece. FAU - Bertsias, George AU - Bertsias G AD - Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece. FAU - Repa, Argyro AU - Repa A AD - Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece. FAU - Avgoustidis, Nestor AU - Avgoustidis N AD - Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece. FAU - Sidiropoulos, Prodromos AU - Sidiropoulos P AD - Department of Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Greece. LA - eng PT - Journal Article PT - Observational Study DEP - 20170828 PL - Italy TA - Clin Exp Rheumatol JT - Clinical and experimental rheumatology JID - 8308521 RN - 0 (Antirheumatic Agents) RN - 0 (Biological Products) RN - 0 (Tumor Necrosis Factor-alpha) SB - IM MH - Adult MH - Aged MH - Antirheumatic Agents/*adverse effects MH - Arthritis, Rheumatoid/diagnosis/*drug therapy/immunology MH - Biological Products/*adverse effects MH - Chemical and Drug Induced Liver Injury/diagnosis/*etiology MH - Female MH - Greece MH - Hepatitis B/diagnosis/immunology/*virology MH - Hepatitis B virus/immunology/*pathogenicity MH - Humans MH - Immunocompromised Host MH - Male MH - Middle Aged MH - Retrospective Studies MH - Risk Factors MH - Time Factors MH - Treatment Outcome MH - Tumor Necrosis Factor-alpha/antagonists & inhibitors/immunology MH - *Virus Activation EDAT- 2017/08/30 06:00 MHDA- 2018/04/25 06:00 CRDT- 2017/08/30 06:00 PHST- 2017/01/22 00:00 [received] PHST- 2017/05/29 00:00 [accepted] PHST- 2017/08/30 06:00 [pubmed] PHST- 2018/04/25 06:00 [medline] PHST- 2017/08/30 06:00 [entrez] AID - 11543 [pii] PST - ppublish SO - Clin Exp Rheumatol. 2018 Jan-Feb;36(1):102-109. Epub 2017 Aug 28.