New interim data from the phase 3b ENHANCE trial (NCT05877963) of patients with multiple sclerosis (MS)demonstrated the tolerability of transitioning from treatment with intravenous (IV) anti-CD20 to ublituximab (Briumvi; TG Therapeutics), a novel monoclonal antibody approved therapy for relapsing forms of MS. These results suggest the successful transition of switching from anti-CD20 therapy to ublituximab for this patient population even with elimination of the starting dose.1,2
Cohort 1 (n = 13), given 450 mg infusion of ublituximab in 2 hours, had a median age of 37 years, 77% of participants were women (n = 10) and the median time since MS diagnosis was 4.4 years. In the currently enrolling cohort 2 given 450 mg infusion of ublituximab in 1 hour, 7 of the dosed participants so far had a median age of 45 years, 71% were women (n = 5) and median time since MS diagnosis was of 3.0 years. For both pooled cohorts, premedications administered included IV methylprednisolone (n = 20, 100%), an antipyretic (paracetamol, n = 13, 65%; ibuprofen, n = 7, 35%) and antihistamines (cetirizine, n = 14, 70%; loratadine, n = 6, 30%; diphenhydramine, n = 1, 5%).
Top Clinical Takeaways
- Ublituximab shows promise in the successful transition of patients with MS from intravenous anti-CD20 therapy, as indicated in interim data from the ENHANCE trial.
- In cohort 1, no infusion-related reactions were reported, while in cohort 2, only mild Grade 1 reactions occurred, demonstrating the overall tolerability of the transition.
- ENHANCE aims to provide more data on the efficacy, tolerability, and immunologic parameters associated with transitioning from anti-CD20 therapy to ublituximab.
Presented at the 2024 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, February 29 to March 2, by coauthor Barry A. Singer, MD, director and founder of The MS Center for Innovations in Care, the 48-week, multicenter study aimed to investigate the maintenance of efficacy and tolerability of transition from current anti-CD20 therapy to ublituximab in participants with MS. The design of the study includes 2 patient cohorts who receive a starting dose of 450 mg of ublituximab, instead of the 150 mg starting dosage, with varying infusion time between either 1 hour or 2 hours.
In cohort 1, investigators reported no infusion related reactions in any of the administered infusions given to patients. In cohort 2, only 2 participants with MS had Grade 1 infusion related reactions, which were mild transient reactions. These Grade 1 infusion related reactions included 1 patient who had throat irritation and another patient who experienced headache and flushing. Authors noted that all other infusions from both cohorts were completed in the protocol specified time without any interruption or slowing.
All told, transition between treatments for patients with MS may happen to address suboptimal response, tolerability, or even patient convenience. Authors noted that enrollment for ENHANCE is ongoing and additional data on the efficacy, tolerability and immunologic parameters will be reported in the future. Additionally, investigators noted that further data is needed to confirm the efficacy and safety associated with this transition since prior anti-CD20 was excluded from the phase 3 ULTIMATE studies (NCT03277261; NCT03277248), which assessed ublituximab in patients with MS.
