Liang Chunhong, Zhang Xueyan, Zhou Lijuan, Zhang Weiquan, Liang Leifeng, Xiao Di, Peng Pingzhi
Office of Drug Clinical Trial Institution, Sixth Affiliated Hospital of Guangxi Medical University, Yulin, 537000, Guangxi, China.
Department of Pharmacy, Sixth Affiliated Hospital of Guangxi Medical University, Yulin, 537000, Guangxi, China.
Int J Clin Pharm. 2025 May 20. doi: 10.1007/s11096-025-01925-z.
Peripheral neuropathy requires early detection and intervention.
This study aimed to examine the association between immunomodulatory medications (IMiDs; thalidomide, lenalidomide, and pomalidomide) and peripheral neuropathy.
OpenVigil 2.1 was used to retrieve data associated with IMiDs and peripheral neuropathy from the FDA Adverse Event Reporting System (FAERS). Disproportionality analysis was performed using the reporting odds ratio (ROR) and information components (IC) with a 95% credibility interval. Peripheral neuropathy signals were further prioritized using a rating scale.
We found 645 cases of peripheral neuropathy in 19,622 adverse event reports for thalidomide, 4849 cases in 197,866 adverse event reports for lenalidomide, and 933 cases in 40,582 adverse event reports for pomalidomide. Based on the clinical priority assessment, peripheral neuropathy was identified as having moderate clinical priority for the three immunomodulatory drugs (priority score = 6). In plasma cell myelomas, more peripheral neuropathy was reported for thalidomide [4.24% vs. 2.51%; ROR = 1.72 (1.42, 2.08); IC = 0.23 (0.05, 0.41)] and lenalidomide [2.71% vs. 1.06%, ROR = 2.59 (2.29, 2.91); IC = 0.14 (0.08, 0.20)] than in non-plasma cell myelomas. Peripheral neuropathy signals were detected in age groups 51-74, 63-74, and 51-62 for lenalidomide, thalidomide, and pomalidomide, respectively. No disproportionate gender differences were detected.
Our study indicated that the risk of peripheral neuropathy varied among patients with different indications and age subgroups for the same IMiD. Further investigation is required to verify these risk signals.
周围神经病变需要早期检测和干预。
本研究旨在探讨免疫调节药物（IMiDs；沙利度胺、来那度胺和泊马度胺）与周围神经病变之间的关联。
使用OpenVigil 2.1从美国食品药品监督管理局不良事件报告系统（FAERS）中检索与IMiDs和周围神经病变相关的数据。使用报告比值比（ROR）和信息成分（IC）进行不成比例分析，并给出95%可信区间。使用评分量表对周围神经病变信号进行进一步排序。
在沙利度胺的19622份不良事件报告中，我们发现645例周围神经病变；在来那度胺的197866份不良事件报告中，发现4849例；在泊马度胺的40582份不良事件报告中，发现933例。根据临床优先级评估，周围神经病变被确定为这三种免疫调节药物具有中等临床优先级（优先级评分 = 6）。在浆细胞骨髓瘤中，沙利度胺[4.24%对2.51%；ROR = 1.72（1.42，2.08）；IC = 0.23（0.05，0.41）]和来那度胺[2.71%对1.06%，ROR = 2.59（2.29，2.91）；IC = 0.14（0.08，0.20）]报告的周围神经病变比非浆细胞骨髓瘤更多。来那度胺、沙利度胺和泊马度胺分别在51 - 74岁、63 - 74岁和51 - 62岁年龄组中检测到周围神经病变信号。未检测到不成比例的性别差异。
我们的研究表明，对于相同的IMiD，不同适应症和年龄亚组的患者发生周围神经病变的风险各不相同。需要进一步研究以验证这些风险信号。
