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

ABSTRACT:

Background

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

Objectives

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.

Design

Secondary analysis of the FAERS database.

Methods

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.

Results

There were 48 reports of MS or

SUBMITTER: Shirani A 

PROVIDER: S-EPMC12627383 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature