Presentation (CTI)

OBJECTIVES: This study evaluated whether there was disproportionate reporting of adverse events (AEs) for ozanimod relative to other disease-modifying therapies (DMTs) indicated for RRMS.
METHODS: This descriptive analysis used all available AE reports from the Food and Drug Administration Adverse Event Reporting System (FAERS) database following ozanimod’s FDA approval (March 2020-June 2023). AE reports and patient outcomes were extracted for all instances where DMTs (ozanimod, dimethyl fumarate, monomethyl fumarate, diroximel fumarate, fingolimod, ponesimod, siponimod, teriflunomide, cladribine, alemtuzumab, natalizumab, ocrelizumab, ublituximab, and ofatumumab) were the ‘primary suspect’ for the AE. Comparisons of ozanimod with other DMTs were based on (1) ten selected AEs found in ozanimod’s label and (2) AEs associated with serious vs. non-serious outcomes. Serious outcomes were defined as life-threatening AEs or those resulting in death, disability, or hospitalization. Reporting odds ratio (ROR) was used to detect signals of disproportionate reporting for ozanimod vs. other DMTs.
RESULTS: A total of 6,576 and 235,964 AE reports were identified for ozanimod and other DMTs, respectively. Ozanimod had a smaller proportion of AEs associated with serious outcomes compared to other DMTs (14% vs 27%, respectively). Within ten selected AEs, which represented 7% of the AE reports for ozanimod and 6% for all other DMTs, ozanimod had disproportionately higher reporting of back pain, hypertension and orthostatic hypotension, and disproportionately lower reporting of upper respiratory tract infections compared to other DMTs.
CONCLUSIONS: Based on this descriptive analysis of the FAERS data, ozanimod has a lower proportion of AEs linked to serious outcomes than the other DMTs. Ozanimod generally had a larger share of the ten labeled AEs compared with the other DMTs; however, these labeled AEs made up a small percentage of all the AEs reported for ozanimod and the other DMTs.