ArticleEClinicalMedicine2022
Risk of hepatitis B virus reactivation following treatment with abatacept: A retrospective study of international pharmacovigilance databases.
Article in EClinicalMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 15 citations in OpenAlex.
- Sex-stratified disproportionality signals of adverse events with allopurinol and febuxostat: a retrospective pharmacovigilance analysis of FAERS and EudraVigilance.Clinical rheumatology · 2026Article
- mRNA vaccines for HBV: Mechanisms, preclinical advances, and therapeutic clinical progress.Molecular therapy. Nucleic acids · 2026Review
- Vonoprazan-related adverse events: a pharmacovigilance study based on the FDA adverse event reporting system.Frontiers in medicine · 2025Article
- Adverse Event Profiles of Adalimumab in Children: A Disproportionality Analysis.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Pharmacological considerations in pharmacotherapy of rheumatology patients with liver disease: a brief narrative review.Reumatologia · 2024Review
- YTHDC1 Regulates the Migration, Invasion, Proliferation, and Apoptosis of Rheumatoid Fibroblast-Like Synoviocytes.Frontiers in immunology · 2024Article
- Research on Liver Damage Caused by the Treatment of Rheumatoid Arthritis with Novel Biological Agents or Targeted Agents.Journal of inflammation research · 2023Review
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Abatacept is a selective T-cell costimulation modulator approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis. Reports were recently published on hepatitis B virus reactivation (HBVr) in patients who were treated with abatacept. However, the literature is limited to case reports and series, and no study has investigated the relationship between HBVr and abatacept using extensive population-based databases. Methods: Using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database, we collected all cases of HBVr between Jan 1, 2006 and June 30, 2021, for abatacept and other drugs. Disproportionality was analysed using the reporting odds ratio (ROR), which was considered significant when the lower limit of the 95% CI was >1. We also conducted a confirmatory analysis in the European pharmacovigilance database, EudraVigilance. Findings: During the study period, 77,669 adverse cases were reported for abatacept use. There were 2889 reports of HBVr with any drug during this period, of which 55 were reported with abatacept. The ROR for HBVr with abatacept was significantly elevated at 4·80 (95% CI 3·68-6·27). All 55 cases of HBVr with abatacept were reported as serious adverse events. Of them, six individuals were hospitalised and four died. Among 832 reports of HBVr with any drug in EudraVigilance, 43 were reported with abatacept; the ROR was 8·99 (95% CI 6·61-12·23). Interpretation: We identified a positive signal between abatacept exposure and HBVr. Future prospective studies should further confirm the relationship and provide evidence to develop strategies involving pre-treatment screening, monitoring, and utilisation of antiviral prophylaxis when using abatacept in patients with rheumatic diseases. Funding: This work was supported by the Fundamental Research Funds for Central Universities (xjh012019063).
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