MS patients see lasting benefits from Briumvi treatment, study says
Data show drug effective after 5 years for those with relapsing MS
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A doctor puts medicine into an IV drip.
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Briumvi (ublituximab) offers sustained benefits for relapsing MS over five years.
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Treatment reduces relapses and disability progression, particularly if started early.
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The infusion therapy is well tolerated over time, with no new safety concerns.
Continued treatment with TG Therapeutics’ Briumvi (ublituximab) provides sustained clinical benefits for people with relapsing forms of multiple sclerosis (MS), particularly if started earlier.
That’s according to data from the ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248) Phase 3 clinical trials and their ongoing open-label extension (NCT04130997).
After five years of follow-up, more than 80% of participants who started Briumvi in the main trials remained free of relapses and of confirmed disability progression, while one in six had improvements in disability. No new safety issues were reported with long-term treatment.
The findings were presented at a medical meeting last year and were recently published in JAMA Neurology in the study, “Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension Study.” The research was funded by TG Therapeutics.
“These data underscore not only the durable clinical efficacy and consistent safety of Briumvi through extended treatment, but also our commitment to advancing long-term evidence that helps clinicians and patients make informed treatment decisions,” Michael S. Weiss, CEO of TG Therapeutics, said in a company press release. “We believe these findings support Briumvi’s continued role as a valuable option for people living with relapsing MS.”
Infusion therapy
Briumvi is an infusion therapy approved to treat adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. Its approval was based on data from the ULTIMATE clinical trials, in which Briumvi significantly outperformed the oral therapy Aubagio (teriflunomide) in reducing relapse rates.
Of the 985 patients who completed two years of clinical testing in ULTIMATE I and II, most (86.4%) entered the open-label extension, in which all continued receiving Briumvi or switched to it from Aubagio.
Of these, 624 (73.3%) stayed on treatment for five years, showing Briumvi was well tolerated and patients adhered to treatment over the long term.
Among patients who received Briumvi for five years, relapse rates continued to decrease over time, from 0.08-0.09 relapses per year at the end of the main trials, to 0.053 in the third year, 0.032 in the fourth year, and 0.02 in the fifth year of treatment.
In patients who switched from Aubagio to Briumvi, relapse rates also dropped significantly, by 58.4%, in the first year after switching, and continued to decline over time, reaching 0.045 relapses per year in the fifth year of follow-up.
After five years, most patients remained relapse-free, though rates were again better in patients who started Briumvi in the main trials (83.6%) than in those who switched from Aubagio (68.9%).
The proportion of patients with confirmed disability progression, or an increase in disability scores that’s sustained for at least 24 weeks, also favored continuous Briumvi treatment. Over five years of treatment, 8% of patients always on Briumvi experienced confirmed disability progression, compared with 14.3% of those who first started on Aubagio.
Confirmed disability improvement, or a lessening in disability sustained for at least 24 weeks, occurred significantly more frequently in the continuous Briumvi group (17%) than in the switch group (12.2%).
Safety remained consistent with previous data. An analysis that tracked side effects relative to the total time patients were treated showed that serious infections occurred at rates of 2.58 and 2.1 per 100 patient-years in the switch and continuous groups, respectively.
No new safety concerns emerged over five years, and overall, continuous treatment with Briumvi was well tolerated.
“Continued treatment over five years provided sustained clinical benefits, with relapse rates declining further over time and disability progression remaining low,” said Bruce Cree, MD, PhD, a professor at the University of California San Francisco Weill Institute for Neurosciences and the study’s first author. “Importantly, the overall safety experience remained consistent over extended follow-up.”
For the researchers, “studies demonstrating the long-term efficacy and safety of [disease-modifying treatments] are important given the lifelong and progressive nature of MS.”
