A real-world study of ublituximab based on the WHO-VigiAccess and U.S. food and drug administration’s adverse event reporting system databases

This study has identified confirmed positive signals associated with ublituximab and revealed potential signals of interest. These findings highlight the need for further regulatory review to assess whether the identified signals justify updates to drug labeling and therapeutic guidelines. Future investigations should build upon the AE signals established in this research, with further investigations warranted to elucidate both the clinical incidence rates of these AEs and their definitive causal relationships with ublituximab.