Peripheral neuropathy associated with immunomodulatory drugs: a pharmacovigilance analysis based on the FDA adverse event reporting system database

Abstract

Background: Peripheral neuropathy requires early detection and intervention.

Aim: This study aimed to examine the association between immunomodulatory medications (IMiDs; thalidomide, lenalidomide, and pomalidomide) and peripheral neuropathy.

Method: 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.

Results: 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.

Conclusion: 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.

Keywords: Database; FDA adverse event reporting system; Immunomodulatory drugs; Peripheral neuropathy; Pharmacovigilance analysis; Signal processing.