Reporting patterns of multiple sclerosis with immune checkpoint inhibitors: analysis of the FDA Adverse Event...

Immune checkpoint inhibitors (ICIs) improve cancer survival but can provoke new or worsening autoimmune disease.

To explore the association of ICIs with multiple sclerosis (MS) using the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database, and to compare the disproportionality signal of MS with that of other autoimmune neurological adverse events.

Secondary analysis of the FAERS database.

We performed a disproportionality analysis of FAERS between 2003-Q4 and 2024-Q2. Outcomes were MS, myasthenia gravis (MG), Guillain-Barré syndrome (GBS), and autoimmune encephalitis (AIE). A signal required ⩾3 reports, proportional reporting ratio ⩾2, and χ² ⩾ 4.

There were 48 reports of MS or MS relapse associated with ICIs. The reporting odds ratio (ROR) for MS or MS relapse was 0.09 (95% confidence interval (CI): 0.068-0.12). In comparison, RORs were 21.05 (95% CI: 19.287-22.974) for MG, 8.075 (95% CI: 6.677-9.766) for GBS, and 29.03 (95% CI: 23.564-35.764) for AIE.

We found no significant safety signal for MS with ICIs, in contrast to MG, GBS, and AIE. This heterogeneity underscores the need for continued pharmacovigilance and mechanistic research.