Infusion-related reactions and premedication patterns in ublituximab-treated multiple sclerosis patients: a...

Ublituximab is a glycoengineered monoclonal antibody that effectively reduces multiple sclerosis (MS) relapses but carries a significant risk of infusion-related reactions (IRRs), which is relatively higher than that reported for some other anti-CD20 agents. This study aims to characterize real-world IRRs associated with ublituximab and describe premedication practices across participating centers.

This multicenter retrospective study included ublituximab-treated MS patients identified from existing medical records (a convenience sample) at MS centers across the United States. Data on demographics, MS phenotype, premedication regimens, and IRRs were collected. Variables were summarized, and Fisher's exact test was used to compare the occurrence and timing of IRRs across baseline and premedication categories. Also, associations between premedication strategies and IRRs were assessed by logistic regression. We conducted statistical analyses using JAMOVI (v2.5). p-values were adjusted for multiple comparisons.

Among 89 patients with multiple sclerosis (PwMS) treated with ublituximab, 34.8% (n = 31) experienced IRRs. All patients received premedication, with the acetaminophen dose being the only component significantly associated with overall IRR occurrence (p = 0.006). Significant differences in reaction timing (immediate versus delayed) were observed across certain corticosteroid and antihistamine categories. All IRRs were mild to moderate in severity.

Approximately one-third (34.8%) of ublituximab-treated patients experienced IRRs, with varied timing and symptom patterns. No independent predictors of IRRs were identified. Importantly, all IRRs observed in this study were mild to moderate, suggesting that ublituximab infusions were generally well tolerated in this real-world cohort.