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Results of Phase 3 Ublituximab Trials Published, Showing Benefit in Relapsing MS

August 29, 2022

Ublituximab (an experimental therapy being developed by TG Therapeutics) reduced relapses and disease activity on MRI scans significantly more than Aubagio® (teriflunomide, Sanofi Genzyme) in two phase 3 clinical trials. These results, originally reported at a medical meeting in 2021, have now been peer-reviewed and published in The New England Journal of Medicine. According to an August 25 press release from TG Therapeutics, the FDA and the European Medicines Agency are currently reviewing applications seeking the approval of ublituximab for the treatment of relapsing MS in adults.
  • Ublituximab is a monoclonal antibody that binds to a molecule (CD20) on the surface of immune cells called B cells, and depletes (removes) them from circulation, similar to Kesimpta® (ofatumumab, Novartis) and Ocrevus® (ocrelizumab, Genentech, Inc.). B cells have several functions including making antibodies, and evidence suggests they play a role in immune-system mediated damage to the brain and spinal cord in MS. Ublituximab is administered as a 1-hour intravenous (IV) infusion every 6 months.
  • Investigators enrolled 1,094 people with relapsing MS for two identical phase 3 studies of ublituximab, known as the ULTIMATE I and ULTIMATE II studies.
  • Participants were randomly assigned to receive either ublituximab infusions and oral placebo, or oral teriflunomide (Aubagio®, Sanofi Genzyme) and placebo infusions for 96 weeks. The primary outcome measured was the rate of relapses per year per participant. Secondary outcomes included safety, disease activity detected on MRI brain scans, and worsening of disability.
  • Results suggested that ublituximab reduced relapse rates and MRI-detected new and/or enlarging brain lesions significantly more than teriflunomide. The percentage of participants with worsening of disability was similar in both treatment groups.
  • Infusion related reactions, such fever, chills, and flu-like symptoms, occurred in nearly half of those taking ublituximab, and were mostly mild to moderate. Six people discontinued treatment due to these reactions. Infections, including serious infections, were commonly experienced by participants in both groups. Three people died as the result of serious infections in the ublituximab groups, compared to none in the teriflunomide groups.
Learn more about medication options for managing MS.
Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis” by Lawrence Steinman, M.D., Edward Fox, M.D., Ph.D., Hans-Peter Hartung, M.D., Enrique Alvarez, M.D., Ph.D., Peiqing Qian, M.D., Sibyl Wray, M.D., Derrick Robertson, M.D., DeRen Huang, M.D., Ph.D., Krzysztof Selmaj, M.D., Ph.D., Daniel Wynn, M.D., Gary Cutter, Ph.D., Koby Mok, Ph.D., et al., for the ULTIMATE I and ULTIMATE II Investigators, is published in The New England Journal of Medicine (2022; 387:704-714).
Aubagio is a registered trademark of Sanofi Genzyme
Kesimpta is a registered trademark of Novartis
Ocrevus is a registered trademark of Genentech, Inc.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.


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