What the trial was testing
The ULTIMATE 1 enrolled 549 patients with multiple sclerosis. The study was sponsored by TG Therapeutics, Inc. and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
People taking ublituximab had 59% fewer relapses than those on teriflunomide.
The New England journal of medicine · 2022 · NCT03277261
These findings — that ublituximab cut relapse rates by more than half compared to teriflunomide — were published in the The New England journal of medicine and represent the headline result of the study.
Researchers tracked outcomes across 549 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with multiple sclerosis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Ublituximab was FDA-approved in 2022 based on these results and is now available as Briumvi. About half of patients had mild reactions during the infusion. Talk to your neurologist about whether this treatment is right for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open multiple sclerosis trials
Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System
The aim of this work is to elaborate a statistical model to predict the effectiveness of robotic treatment in subjects with neurological diseases. The model will be used to understand which subjects are most responsive to this type of treatment
Genes and Environment in Multiple Sclerosis
The purpose of the research study is to identify the genetic, environmental and immune profiles that may increase a person's risk of developing multiple sclerosis (MS). While MS is not a disease caused by a single variation in genetic material (DNA), a single environmental factor, or a single malfunction in immune cells, there are genetic alterations, environmental exposures and immunologic factors that make the development of MS more likely. Obtaining information about who is at risk for MS will be beneficial in the future if the investigators can identify effective ways to prevent or slow down the progression of this disease.