阿巴西普治疗后乙型肝炎病毒再激活的风险：一项对国际药物警戒数据库的回顾性研究。
Risk of hepatitis B virus reactivation following treatment with abatacept: A retrospective study of international pharmacovigilance databases.
作者信息
Wang Jingjing, Zhang Xin, Geng Xiaozhen, Shi Juanjuan, Jia Xiaoli, Dang Shuangsuo, Wang Wenjun
机构信息
Department of Pediatrics, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Department of Infectious Diseases, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
出版信息
EClinicalMedicine. 2022 May 5;48:101425. doi: 10.1016/j.eclinm.2022.101425. eCollection 2022 Jun.
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).
背景
阿巴西普是一种选择性T细胞共刺激调节剂，已被批准用于治疗类风湿性关节炎、幼年特发性关节炎和银屑病关节炎。最近有关于接受阿巴西普治疗的患者出现乙型肝炎病毒再激活（HBVr）的报道。然而，文献仅限于病例报告和系列病例，尚无研究使用基于广泛人群的数据库调查HBVr与阿巴西普之间的关系。
方法
我们使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库，收集了2006年1月1日至2021年6月30日期间阿巴西普及其他药物引起的所有HBVr病例。使用报告比值比（ROR）分析不成比例性，当95%置信区间的下限>1时，认为具有显著性。我们还在欧洲药物警戒数据库EudraVigilance中进行了验证性分析。
结果
在研究期间，报告了77669例使用阿巴西普的不良事件。在此期间，有2889例报告了任何药物引起的HBVr，其中55例与阿巴西普有关。阿巴西普引起HBVr的ROR显著升高，为4.80（95%置信区间3.68 - 6.27）。所有55例阿巴西普引起的HBVr均被报告为严重不良事件。其中，6人住院，4人死亡。在EudraVigilance中832例任何药物引起的HBVr报告中，43例与阿巴西普有关；ROR为8.99（95%置信区间6.61 - 12.23）。
解读
我们确定了阿巴西普暴露与HBVr之间的阳性信号。未来的前瞻性研究应进一步证实这种关系，并为在风湿性疾病患者中使用阿巴西普时制定涉及治疗前筛查、监测和使用抗病毒预防措施的策略提供证据。
资金
这项工作得到了中央高校基本科研业务费专项资金（xjh012019063）的支持。
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