Briumvi may outperform other MS therapies, indirect comparison shows

Briumvi (ublituximab-xiiy) may be more effective than Kesimpta (ofatumumab) or Ocrevus (ocrelizumab) at preventing disability progression among people with relapsing forms of multiple sclerosis (MS), according to an indirect comparison of clinical trial data.

“In the absence of head-to-head clinical trials, [matching-adjusted indirect comparison] provides a valuable statistical approach to evaluating comparative treatment outcomes while accounting for differences in patient populations across studies,” Michael S. Weiss, chairman and CEO of TG Therapeutics, Briumvi’s developer, said in a company press release. “We are encouraged that this analysis showed that BRIUMVI was associated with consistently lower relapse activity versus [Ocrevus] and a lower risk of confirmed disability progression compared with both [Ocrevus] and [Kesimpta] over five years.”

The findings were described in the study “Long-term comparative outcomes in relapse activity and disability progression among anti-CD20 therapies in relapsing multiple sclerosis: An unanchored matching-adjusted indirect comparison,” which was published in Multiple Sclerosis and Related Disorders.

The study was funded by Neuraxpharm, which commercializes Briumvi in Europe under an agreement with TG Therapeutics, and two its authors are employees of these companies.

“We believe these findings add to the growing body of evidence supporting the durable efficacy profile of BRIUMVI and its potential to provide meaningful long-term benefit for people living with MS,” Weiss said.

Still, “findings are exploratory and require confirmation in direct comparative studies,” researchers wrote.

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Three therapies have some important differences

MS is a disease marked by abnormal immune attacks against the myelin sheath, a protective coating around nerve fibers that allows fast transmission of nerve signals. This eventually causes nerve damage and a wide range of symptoms.

In most people with the disease, MS is marked by flares or relapses, where symptoms suddenly worsen due to new inflammatory activity. Relapses contribute to the accumulation of disability.

Briumvi, Ocrevus, and Kesimpta are approved disease-modifying treatments for relapsing forms of MS. They all belong to a class of medications called anti-CD20 monoclonal antibodies, which work by targeting CD20, a protein present at the surface of disease-driving immune cells called B-cells.

Despite their similar mechanism of action, the three therapies have some important differences. One key distinction is how they are administered. Briumvi is given by infusion into the bloodstream; the first two infusions are given two weeks apart, and subsequent infusions are given every six months.

In an era where physicians and patients are fortunate to have multiple anti-CD20 treatment options available for relapsing MS, the lack of comparative data makes choosing the right one challenging.

Ocrevus, sold by Roche’s subsidiary Genentech, is also administered by infusion into the bloodstream on a similar schedule. An alternate version of the therapy, Ocrevus Zunovo, is given every six months by under-the-skin, or subcutaneous, injection. Meanwhile, Novartis’ Kesimpta is administered by subcutaneous injection once monthly.

In addition to differences in how they’re given, specific biochemical properties also vary among these three anti-CD20 medications. But do the therapies meaningfully differ in terms of long-term outcomes for patients?

That question has been difficult to answer because there haven’t been any clinical trials directly comparing these therapies. Trials testing each medicine individually have proven that each of them can reduce relapse risk and disability progression. However, because these studies enrolled patients with different starting characteristics, it’s tough to make reliable comparisons.

“In an era where physicians and patients are fortunate to have multiple anti-CD20 treatment options available for relapsing MS, the lack of comparative data makes choosing the right one challenging,” Weiss said. “This is particularly important for people living with a chronic disease like MS, where preventing the accumulation of disability over time is an important treatment goal.”

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Briumvi associated with lower relapse rates

Here, researchers utilized matching-adjusted indirect comparison, a statistical approach that aims to adjust for differences in starting characteristics across clinical trials of each individual drug, allowing researchers to make more reliable comparisons.

Data showed that, over five years of follow-up, the risk of 24-week confirmed disability progression (CDP24; disability worsening that lasts for at least six months) was significantly lower with Briumvi.

Specifically, the risk was lowered by 44% compared with Ocrevus and by 49% compared with Kesimpta. Both these differences were statistically significant, meaning it’s highly unlikely they are due to random chance.

Patients on Briumvi also lived significantly longer without CDP24, by about two additional months relative to those on Ocrevus and about three additional months compared with those on Kesimpta.

Briumvi was also associated with lower relapse rates compared with Ocrevus or Kesimpta. However, due to technical limitations, the researchers were unable to conduct formal statistical analyses in relapse rate comparisons, so they cautioned that these results should be considered exploratory.

And more broadly, the researchers emphasized that the findings should be interpreted cautiously, and called for further studies to directly compare outcomes.

“These findings … should be considered complementary to previous short-term [clinical trial] treatment evidence, pending confirmation from direct comparative studies or robust real-world evidence,” the scientists wrote.