Department of Pharmacy, Levine Cancer Institute, Atrium Health, 1021 Morehead Medical Drive, Charlotte, NC, 28204, USA.
Department of Pharmacy, Levine Cancer Institute, Atrium Health, 100 Medical Park Drive, Concord, NC, 28025, USA.
Int J Clin Pharm. 2023 Dec;45(6):1492-1495. doi: 10.1007/s11096-023-01608-7. Epub 2023 Jun 8.
Daratumumab and isatuximab are anti-CD38 monoclonal antibodies indicated for the treatment of multiple myeloma. These agents can increase the risk of infectious complications, including viral infections. Cases of hepatitis B virus (HBV) reactivation have been reported in the literature in patients receiving anti-CD38 monoclonal antibody-based therapies.
The objective of this analysis was to determine if the association between anti-CD38 monoclonal antibody exposure and the development of hepatitis B reactivation had a detectable reporting signal in the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).
We conducted a post marketing pharmacovigilance analysis by querying the FAERS for reports of HBV reactivation with daratumumab or isatuximab exposure reported between 2015 and 2022. Disproportionality signal analysis was conducted by calculating reporting odds ratios (RORs).
Sixteen cases of hepatitis B virus reactivation were reported in the FAERS database among patients receiving daratumumab or isatuximab reported between 2015 and 2022. The ROR for HBV reactivation was statistically significant for both daratumumab (ROR 4.76, 95% CI 2.76-8.22) and isatuximab (ROR 9.31, 95% CI 3.00-28.92).
Overall, our analysis demonstrates a significant reporting signal for HBV reactivation with daratumumab and isatuximab.
达雷妥尤单抗和伊沙妥昔单抗是两种抗 CD38 单克隆抗体，用于治疗多发性骨髓瘤。这些药物会增加感染并发症的风险，包括病毒感染。文献中已有报道称，接受抗 CD38 单克隆抗体治疗的患者会出现乙型肝炎病毒（HBV）再激活的情况。
本分析旨在确定抗 CD38 单克隆抗体暴露与 HBV 再激活之间的关联是否在美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）中存在可检测的报告信号。
我们通过查询 FAERS 中 2015 年至 2022 年期间报告的达雷妥尤单抗或伊沙妥昔单抗暴露与 HBV 再激活相关的报告，进行了上市后药物警戒分析。通过计算报告比值比（ROR）进行了比例失调信号分析。
在 2015 年至 2022 年期间，FAERS 数据库中报告了 16 例接受达雷妥尤单抗或伊沙妥昔单抗治疗的患者发生 HBV 再激活的病例。HBV 再激活的 ROR 对于达雷妥尤单抗（ROR 4.76，95%CI 2.76-8.22）和伊沙妥昔单抗（ROR 9.31，95%CI 3.00-28.92）均具有统计学意义。
总体而言，我们的分析表明达雷妥尤单抗和伊沙妥昔单抗与 HBV 再激活之间存在显著的报告信号。
