An Updated Evaluation of Multiple Sclerosis Outcomes After Immune Checkpoint Inhibitors from the FAERS Database
Catherine Garcia1, Niharika Reddy2, Julia Magsam3, John L. Villano2
1University of Texas MD Anderson Cancer Center, 2University of Kentucky, 3Georgetown College
Objective:
To describe the outcomes of multiple sclerosis (MS) reported as an adverse event after immune checkpoint inhibitor (ICI) treatment using the FDA Adverse Event Reporting System (FAERS).
Background:
ICIs have been associated with immune related adverse events, but MS is a rare presentation of immunotoxicity. Our team previously described the outcomes of MS as an adverse event of ICI from FAERS, we aim to provide an updated analysis using this database.
Design/Methods:
We searched the FDA Adverse Event Reporting System (FAERS) database for “multiple sclerosis” for “ipilimumab”, “durvalumab”, “atezolizumab”, “ipilimumab” and “durvalumab”.
Results:
We found a total of 64 cases classified as MS, with 48.4% females. Cases were specified as a relapse in 26.6%. Over 23% presented with other neurological symptoms that included autoimmune encephalitis (4.8%), myelitis (3.2%), and peripheral neuropathy (3.1%). Around 9% of patients had other autoimmune diseases that included autoimmune hepatitis (3.2%), and hypophysitis (4.7%). More than one ICI was reported in 7.8% of patients. The most common primary cancer site was lung cancer (28.1%), followed by melanoma (26.6%), and renal cancer (10.9%). Outcomes were collected as reported by FAERS, and documented as 7.8% with disability, 28.1% requiring hospitalization, and 3.1% of events described as life threatening. Death was reported in 6.3% of cases.
Conclusions:
MS as an adverse event of ICI is a rare presentation of neurotoxicity. Some patients presented with other neurological symptoms, and the presence of other immune mediated diseases was low. Most patients did not require hospitalization and less than 8% had disability.
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