Fewer relapses seen with newer vs. older treatment in ULTIMATE I and II
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A doctor shares medical information, seen on a tablet, with an older patient. (Photo from iStock)
For relapsing multiple sclerosis, Briumvi significantly outperforms Aubagio as a first-line treatment, an analysis found.
Use of Briumvi leads to fewer relapses, reduced MRI activity, and improved disability outcomes, especially when started early, the data showed.
These retrospective findings support early use of high-efficacy therapies, but prospective head-to-head trials are still needed, the researchers say.
First-line treatment with TG Therapeutics’ Briumvi (ublituximab) in clinical trials among people with relapsing forms of multiple sclerosis (MS) led to significantly fewer relapses, reduced signs of MRI disease activity, and better disability outcomes compared with those given the older drug Aubagio (teriflunomide) as their initial therapy.
That’s according to new post-hoc analyses of ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248), planned and conducted after the trials were complete. Both trials wrapped up in 2020, with Briumvi later approved in the U.S. in 2022. Aubagio had initially won approval in the U.S. a decade earlier.
The new data also show that using Briumvi rather than Aubagio as a first treatment led to particularly better outcomes when given early in the disease course — specifically, within three years of symptom onset.
“These findings add to the growing body of evidence supporting the early use of high-efficacy therapies to help improve long-term outcomes for people living with relapsing multiple sclerosis,” Michael S. Weiss, executive chairman and CEO of TG Therapeutics, said in a company press release announcing the publication of the analyses’ results.
The study, “Disease outcomes with ublituximab in treatment-naïve participants: subpopulation analyses of the phase 3 ULTIMATE I and II studies in participants with relapsing multiple sclerosis,” was published in the journal Frontiers in Immunology. It was funded by TG Therapeutics; five of the 14 researchers work at the company.
MS occurs when the immune system attacks the myelin sheath, the protective covering of nerve fibers, causing a range of symptoms. For some people with MS, the disease follows an active course, with frequent relapses — periods when symptoms suddenly worsen, or new ones appear — and evidence of disease activity on MRI scans.
Briumvi is a newer infusion therapy approved for adults with relapsing forms of MS, such as clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. Its approval drew on data from the ULTIMATE Phase 3 clinical program, in which Briumvi significantly reduced relapse rates, lowered the number of lesions, and led to more patients experiencing an easing of disability compared with Aubagio.
In this analysis, the researchers focused on a subset of patients in the ULTIMATE trials who had not previously received a disease-modifying therapy. All started on Briumvi or Aubagio — an older drug approved in the U.S. in 2012 — as their first-line treatment. The team also assessed outcomes for a group of treatment-naïve participants who experienced their first symptoms within three years of enrollment in these trials.
The analysis altogether covered 722 treatment-naïve patients, 279 of whom were treated early in the disease course. Compared with the overall treatment-naïve population, the early treatment group tended to be younger and have less severe disability.
The results showed that Briumvi significantly outperformed Aubagio in various measures of disease activity and progression. Some outcomes tended to be better in the early treatment group, the researchers noted.
For example, Briumvi reduced relapse rates by 57% in the overall population and by 61% in the early treatment group — with the researchers noting that “relapse reductions can provide significant clinical benefits for patients in both the short and longer term.”
The therapy also led to twice as many people in the overall group (11% vs. 5%) experiencing confirmed disability improvement, or an easing of disability, with a fourfold improvement observed in the early treatment group (14% vs. 4%), according to the data.
The proportion of patients with confirmed disability progression was low and similar between the two groups, and not significantly different from people given Augabio, as had also been observed in the overall trials population.
Additionally, the data show that new or enlarging lesions and lesions with active inflammation were significantly reduced with Briumvi compared with Aubagio. Participants experienced a more than 90% reduction in those lesions, regardless of when treatment was first started.
Finally, the researchers measured the proportion of patients who achieved a composite measure called no evidence of disease activity, or NEDA, which signals the absence of relapses, new MRI activity, and worsening disability.
Data showed that about 3.6 times as many people in the treatment-naïve population who received Briumvi achieved this outcome compared with those who received Aubagio (83% vs. 23%). For those who received early treatment, the proportion was 3.4 times higher with Briumvi (81% vs. 24%).
“[Briumvi] was associated with significant treatment benefits across multiple efficacy measures,” the researchers wrote. “The findings of the current analyses … are consistent with the treatment benefits of other anti-CD20 [antibodies] in treatment-naïve people with MS overall and in early stage disease.”
Altogether, the researchers concluded that these new findings “support the efficacy of [Briumvi] in these clinical populations.” Still, the study’s retrospective nature and the “small number” of treatment-naïve patients were noted as “key limitations.”
As such, “prospective, randomized, head-to-head trials are warranted to compare the efficacy and safety of different high-efficacy [disease-modifying therapies] early in the disease course in people with [relapsing forms of] MS,” the team wrote.
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