1. Commensurate incidence and outcomes of liver enzyme elevation between anti-tumor necrosis factor users with or without prior hepatitis B virus infections.
- Author
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Chiu YM, Lai MS, and Chan KA
- Subjects
- Adult, Aged, Aged, 80 and over, Alanine Transaminase blood, Antirheumatic Agents therapeutic use, Arthritis, Psoriatic virology, Arthritis, Rheumatoid virology, Female, Hepatitis B Antibodies blood, Hepatitis B Surface Antigens blood, Humans, Immunosuppression Therapy, Incidence, Liver drug effects, Male, Middle Aged, Retrospective Studies, Spondylitis, Ankylosing virology, Virus Activation drug effects, Young Adult, Antirheumatic Agents pharmacology, Arthritis, Psoriatic drug therapy, Arthritis, Rheumatoid drug therapy, Hepatitis B drug therapy, Liver enzymology, Spondylitis, Ankylosing drug therapy, Tumor Necrosis Factor-alpha antagonists & inhibitors
- Abstract
Background and Objective: Potential hepatoxicity is an important clinical concern when administering immunosuppressive therapies to patients infected by hepatitis B virus (HBV). Tumor necrosis factor inhibitors (anti-TNF) increase the likelihood of hepatitis consequent to HBV reactivation, but reported risks and outcomes vary. We determined the risks of liver enzyme elevation in anti-rheumatic drug users from an HBV-endemic region with differing HBV serostatus., Methods: We established retrospective cohorts with rheumatoid arthritis, ankylosing spondylitis, or psoriasis/psoriatic arthritis who: 1) received anti-TNF agents from 1 January 2004 to 30 June 2013; 2) received care from 1 June 2011 to 30 June 2013 but only ever used conventional disease-modifying anti-rheumatic drugs (DMARDs). Serology results defined three subgroups: HBV surface antigen positive (HBsAg+), HBsAg negative/HBV core antibody positive (HBsAg-/HBcAb+), or uninfected. We compared incidences of serum alanine aminotransferase (ALT) exceeding twice the upper reference limit between HBV serostatus subgroups in each treatment cohort., Results: Among 783 patients treated with anti-TNF (n = 472) or DMARDs only (n = 311), HBsAg-/HBcAb+ anti-TNF users had incidence of ALT elevation commensurate with uninfected counterparts (6.1 vs. 6.0/100 person-years), compared to 19.6/100 person-years in HBsAg+ patients (standardized rate ratio 3.3, 95% CI 1.3-8.2); none effected had severe or fatal hepatitis and ALT levels in all HBsAg-/HBcAb+ patients remained stable, mostly normalizing spontaneously, or after moderating treatment. Patterns of of ALT elevation associated with differing HBV serostatus in the DMARD cohort, resembled those in anti-TNF users., Conclusions: In this large HBV-endemic cohort, the absolute incidence of ALT elevation in anti-TNF users was more than three-fold higher in HBsAg+ patients than in uninfected counterparts; however, no such association was evident in patients with HBsAg-/HBcAb+ serotype, whose risk and outcomes of liver enzyme elevation were similar to uninfected patients, suggesting that anti-TNF use by HBsAg-/HBcAb+ patients is probably safe.
- Published
- 2018
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