ACTRIMS 2024: Switch to Briumvi well tolerated in relapsing MS
A benefit of newer CD20 inhibitor is it has shorter infusion time
People with relapsing forms of multiple sclerosis (MS) being treated with an infusion CD20 inhibitor such as Ocrevus (ocrelizumab) can safely transition to the more recent Briumvi (ublituximab-xiiy), which is given in shorter infusion times.
That’s according to data from the ENHANCE Phase 3b clinical trial (NCT05877963), where patients who switched directly to a one-hour infusion of Briumvi at its recommended 450 mg dose rather than the initial 150 mg dose reported only a few mild infusion-related reactions.
The medication also reduced B-cells to undetectable levels in all patients, including those with measurable levels while on the previous therapy.
“It was encouraging to see that patients who switched to one-hour Briumvi experienced a manageable safety and tolerability profile,” Michael S. Weiss, CEO and chairman of Briumvi’s developer TG Therapeutics, said in a company press release. “We look forward to continuing to present updated data from this trial throughout the year.”
Barry Singer, MD, professor of clinical neurology and director of The MS Center for Innovations in Care at Missouri Baptist Medical Center, presented the data at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024, held last week in Florida and virtually. Singer’s poster was titled “Evaluating the Maintenance of Efficacy and Tolerability of Transitioning From IV Anti-CD20 Therapy to Ublituximab: ENHANCE Study Interim Data.” The work was funded by TG Therapeutics.
Switching MS medicines
MS patients may need to switch medication for different reasons, either because the current one isn’t controlling the disease, is causing side effects, or isn’t convenient.
But data is needed to understand how safe and tolerable it is to switch from one therapy to another and certain protocols may be required to reduce side effects while providing better disease control.
Briumvi is a newer CD20 inhibitor approved in 2022 for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
It works like Ocrevus, Kesimpta (ofatumumab), and rituximab, which is sometimes used off-label for MS. All four therapies target the CD20 receptor at the surface of B-cells, immune cells thought to contribute to the inflammatory attack that drives MS, causing their death.
While Kesimpta is given monthly via an injection under the skin, or subcutaneously, the others are given every six months via injections into the vein (intravenously). Neurologists believe Briumvi may be more convenient than other intravenous alternatives because it can be infused in an hour.
ENHANCE is testing if MS patients on other intravenous CD20 inhibitors can safely switch to Briumvi without losing efficacy.
While Briumvi is generally started with an infusion of 150 mg over four fours, followed by another of 450 mg over an hour two weeks later, the trial’s patients are skipping the initial infusion.
“Patients transitioning from previous anti-CD20 therapy in a B-cell depleted state were … hypothesized to not require a 150 mg starting dose prior to initiating a full 450 mg IV infusion,” the researchers wrote.
The initial 450 mg dose is being studied with varying infusion times, however. One group is receiving it over two hours and a second group over an hour, after which all injections are being given over one hour every six months.
To reduce the risk of infusion reactions, patients received intravenous corticosteroids, antipyretics to reduce fever, and antihistamines to prevent allergic reactions before treatment.
At the time of the analysis, 34 patients, median age 37-42, were enrolled in the trial. All had been receiving treatment with Ocrevus, with the number of injections ranging from three to 14, but over half saw its effects wearing off.
Thirteen patients received the first infusion in two hours and 21 in one hour. In the first group, no infusion reactions were reported. All patients completed the infusion with no interruption or slowing.
In the second group, four (19%) patients had mild reactions — two had headache, one had allergic rhinitis (inflammation of the nose), one flushing, and one a scratchy throat. Still, most (86%) completed the infusion with no interruption or slowing and the median infusion time remained an hour.
Before treatment with Briumvi, 91% of patients had undetectable B-cells. After treatment, all (100%) had undetectable B-cells at weeks 12 and 24, indicating Briumvi could reduce B-cell numbers in patients in whom Ocrevus fell short. None of the seven patients who received a second infusion at week 24 had infusion reactions.
Because the ENHANCE trial is still ongoing, “additional efficacy, safety and tolerability will be reported in the future,” the researchers wrote.
Note: The Multiple Sclerosis News Today team is providing coverage of the ACTRIMS Forum 2024 Feb. 29-March 2. Go here to read the latest stories from the conference.
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