New MS treatment shows promise in trials | Health

THURSDAY, Aug. 25, 2022 (HealthDay News) — An experimental antibody therapy for multiple sclerosis can cut symptom flare-ups in half compared to standard treatment, a new clinical study suggests.

Drug, name ublituximabbeat the standard oral drug for MADAM in the reduction of relapses in patients – periods of the appearance of new or worsening symptoms. It has also been shown to be the best at preventing inflammatory damage in the brain.

Ublituximab is not yet approved for the treatment of MS; The U.S. Food and Drug Administration is reviewing the trial data and is expected to make a decision by the end of the year, according to drugmaker TG Therapeutics.

If approved, ublituximab would be the latest in a new class of MS treatments called anti-CD20 monoclonal antibodies: lab-made antibodies that target specific immune system cells that control the MS process.

The new findings offers further evidence that this approach benefits patients, according to an expert who was not involved in the trial.

“Is this a revolution? No. But this is further confirmation of the clinical benefit of targeting this population of cells in the blood,” said Dr. Lauren Krupp, who directs the Center for Comprehensive Multiple Sclerosis Treatment at NYU Langone in New York.

MS is a neurological disease that usually occurs between the ages of 20 and 40. It is caused by a mistaken attack of the immune system on its own body myelin — protective sheath around nerve fibers in the spine and brain. Depending on the location of the injury, symptoms include vision problems, muscle weakness, numbness, and difficulty with balance and coordination.

Most people with MS have relapsing-remitting a form in which symptoms intensify for a while, then ease. Over time, the disease becomes more steadily progressive.

Immune system cells called B cells appear to play a particularly key role in the development of MS. Thus, in recent years, monoclonal antibodies have been created that destroy B-cells in the blood. One, called ocrelizumab (Ocrevus)was approved in the United States in 2017. the second – ofatumumab (kesympto) – followed in 2020.

Both antibodies deplete B cells by targeting a protein on the cells called CD20. Ublituximab has the same target, but is designed to be more potent in killing B cells, said Dr. Lawrence Steinman, lead investigator of the new trial.

The trial did not compare ublituximab with any of the existing anti-CD20 antibodies, emphasized Steinman, a professor of neurology at Stanford University. So it is not known whether it is more or less effective.

But a potential advantage of the new antibodies, Steinman said, is that they can be administered quickly.

Both Ocrevus and ublituximab require patients to visit a medical facility for an infusion every six months. But Ocrevus takes about three hours to infuse, while ublituximab can be given in one hour.

Kesimpta, meanwhile, avoids infusion altogether. It is taken at home once a month using an auto-injector.

“There are different solutions for different people,” Steinman said. “I think it’s always good to have options.”

Findings published on August 25 in New England Journal of Medicine, based on more than 1,000 patients with MS, mostly relapsing-remitting MS. A small percentage had secondary progressive MS, the second phase of the disease that followed a relapsing-remitting period.

About half were randomly assigned to infusions of ublituximab, while the other half received oral medication Aubagio (teriflunomide).

Over 96 weeks, patients on ublituximab were half as likely to relapse — with an annual average of just under 0.1 versus nearly 0.2 among Aubagio patients. And on an MRI, they showed fewer areas of inflammation in the brain.

B cells are responsible for producing antibodies that fight infection. Therefore, the main safety concern with depleting B cells is that it can make people more vulnerable to infection. That was the case in this trial: 5% of patients with ublituximab developed a serious infection, including pneumonia, compared with 3% of patients with Aubagio.

There are many drugs approved for the treatment of MS. But Krupp said some recent studies show that patients do better in the long term when they get “highly effective” drugs — including anti-CD20 antibodies — compared to older drugs with more moderate effects.

According to Steinman, when it comes to starting a highly effective treatment, sooner is better.

“My philosophy is if insurance will cover it, hit the disease hard and fast,” he said.

This raises the real issue of cost: CD20 monoclonal antibodies are expensive; The current price for Ocrevus is about $68,000 a year, according to drug maker Genentech.

Both Krupp and Steinman said that often decisions about medications depend on which ones are covered by a patient’s insurance plan.

Additional information

The National Multiple Sclerosis Society has more information MS treatment.

SOURCES: Lawrence Steinman, MD, director and professor of neurology and neuroscience and pediatrics, Stanford University Beckman Center for Molecular Medicine, Stanford, CA; Lauren Krupp, MD, director of the NYU Langone Center for Comprehensive Multiple Sclerosis and professor of child neuropsychiatry at NYU Grossman School of Medicine, New York; New England Journal of MedicineAugust 25, 2022