Real-world safety assessment of ublituximab: a pharmacovigilance analysis based on the FDA adverse event reporting...

Ublituximab, a novel glycoengineered murine/human type Ⅰ chimeric IgG1-class monoclonal antibody targeting a unique CD20 epitope, is approved for the management of relapsing forms of multiple sclerosis in adults. While the safety and efficacy of ublituximab have been evaluated in several randomized clinical trials, real-world pharmacovigilance data remain limited.

This study aimed to evaluate the post-marketing adverse events (AEs) associated with ublituximab utilizing the FDA Adverse Event Reporting System (FAERS) database, thereby delineating the safety profile of ublituximab in the post-approval setting.

The AE reports of ublituximab as the primary suspected drug from Q4 2022 to Q4 2024 were collected from the FAERS database. Disproportionality analysis, including the Reporting Odds Ratio, the Proportional Reporting Ratio, the Bayesian Confidence Propagation Neural Network, and the Multi-Item Gamma Poisson Shrinker, was performed to identify potential safety signals associated with ublituximab. Complementary analyses, comprising subgroup analysis, Weibull distribution, and sensitivity assessment, were conducted to characterize the ublituximab-associated AEs.

A total of 1,190 reports encompassing 448 distinct AEs were collected. Known AEs that are consistent with the FDA label, such as infusion-related reactions (n = 591, ROR = 271.35, 95% CI 246.57-298.61) and infections (urinary tract infection: n = 28, ROR = 4.31, 95% CI 2.97-6.27; Respiratory tract infection: n = 8, ROR = 7.39, 95% CI 3.69-14.8), were reaffirmed, along with unexpected AEs like alopecia (n = 12, ROR = 2.06, 95% CI 1.17-3.64) and headache (n = 50, ROR = 2.55, 95% CI 1.93-3.38). The Weibull distribution characteristic of AEs is an early failure type, which indicates that vigilant monitoring in the initial treatment cycle is critical. Subgroup analyses revealed variations in the distribution across age and gender subgroups. Sensitivity analysis confirmed the consistency and robustness of the data.

This study provided preliminary insights into the post-marketing safety profile of ublituximab by confirming its known AEs and investigating unexpected AEs. These findings contribute to evidence-based risk minimization strategies and pharmacovigilance activities for ublituximab in clinical practice.