Long-term efficacy and safety of ublituximab in the treatment of multiple sclerosis: A critical review of medical literature.

BACKGROUND: Ublituximab(UTX) is a novel, glycoengineered anti-CD20 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) that enables efficient B-cell depletion at lower doses and shorter infusion times compared to other anti-CD20 therapies. This critical review synthesizes evidence on the long-term efficacy and safety of UTX in relapsing forms of multiple sclerosis (MS). OBJECTIVE: To critically evaluate ublituximab's long-term efficacy and safety in relapsing MS via clinical evidence synthesis. METHODS: We reviewed peer-reviewed literature, clinical trials, extension studies, observational reports, and recent conference posters/abstracts, providing a qualitative overview. RESULTS: UTX shows sustained disease control, including reduced relapses and MRI activity, over extended periods in relapsing MS patients. B-cell depletion remains effective long-term, with a safety profile typical of anti-CD20 therapies, including manageable infusion reactions and stable monitoring for infections and immunoglobulins. CONCLUSIONS: UTX represents a potent, efficient disease-modifying therapy for relapsing MS with robust, durable efficacy comparable to other anti-CD20 agents. Its primary clinical advantage is the streamlined one-hour maintenance infusion every 24 weeks. While the absence of head-to-head trials against other high-efficacy agents and knowledge gaps regarding long-term safety in diverse populations remain limitations, current evidence supports ublituximab's position in aggressive early-treatment strategies, provided that clinical vigilance for cumulative risks such as hypogammaglobulinemia is maintained. Future research should prioritize comparative trials, investigation in progressive MS phenotypes, and validation of optimized dosing strategies.