New MS treatment shows promise in trial

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By Amy Norton
Health Day Reporter

THURSDAY, August 25, 2022 (HealthDay News) — An experimental antibody therapy for multiple sclerosis may reduce symptom flare-ups by half compared to standard treatment, a new clinical study has found.

The drug, called ubituximab, beat a standard oral drug for MS by reducing patients’ flare-ups – periods of new or worsening symptoms. It has also been shown to be better at preventing areas of 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 study data and is expected to make a decision by the end of the year, according to drugmaker TG Therapeutics.

If approved, ubituximab would be the latest in a newer group of MS therapies called anti-CD20 monoclonal antibodies: lab-made antibodies that target specific cells in the immune system that drive the MS process.

The new results provide further evidence that the approach benefits patients, according to an expert not involved with the study.

“Is that revolutionary? no But it’s further confirmation of clinical utility in targeting this cell population in the blood,” said Dr. Lauren Krupp, who directs NYU Langone’s Multiple Sclerosis Comprehensive Care Center in New York City.

MS is a neurological disease that usually occurs between the ages of 20 and 40. It is caused by a misguided attack by the immune system on the body’s myelin – the protective covering around nerve fibers in the spine and brain. Depending on where the damage occurs, symptoms include blurred vision, muscle weakness, numbness, and difficulties in balance and coordination.

Most people with MS have the relapsing-remitting form, in which symptoms flare up for a period of time and then subside. Over time, the disease steadily progresses.

Cells of the immune system, so-called B-cells, appear to play a particularly important role in the development of MS. In recent years, therefore, monoclonal antibodies have been developed that deplete the blood of B cells. One called ocrelizumab (Ocrevus) was approved in the United States in 2017. A second – ofatumumab (Kesimpta) – followed in 2020.

Both antibodies degrade B cells by targeting a protein on the cells called CD20. Ublituximab has the same target, but it’s designed to kill B cells more effectively, said Dr. Lawrence Steinman, lead investigator on the new study.

The study did not compare ubituximab to any of the existing anti-CD20 antibodies, said Steinman, a professor of neurology at Stanford University. So it is not known if it is more or less effective.

But one potential benefit of the new antibody, Steinman said, is that it can be administered quickly.

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

Kesimpta, on the other hand, avoids infusions entirely. It is taken at home once a month with an auto-injector.

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

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

About half were randomly assigned to receive ubituximab infusions, while the other half took the oral drug Aubagio (teriflunomide).

Over a 96-week period, ulituximab patients were half as likely to relapse, at a median annual rate of just under 0.1 versus almost 0.2 for Aubagio patients. And on MRI scans, they showed fewer foci of inflammation in the brain.

B cells are responsible for producing infection-fighting antibodies. So, a major safety concern with B-cell depletion is that people may become more susceptible to infection. This was the case in this study: 5% of ulituximab patients developed a serious infection, including pneumonia, compared to 3% of Aubagio patients.

There are many drugs approved to treat MS. However, Krupp said some recent studies show that patients do better long-term when given “high potency” drugs — which include anti-CD20 antibodies — compared to older drugs with more moderate effects.

For Steinman, earlier is better when it comes to starting a highly effective treatment.

“My philosophy is, if the insurance covers it, knock down the disease hard and fast,” he said.

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

So often, both Krupp and Steinman said, drug decisions depend on which ones are covered by a patient’s insurance plan.

More information

The National Multiple Sclerosis Society has more on treating MS.

SOURCES: Lawrence Steinman, MD, Director and Professor, Neurology and Neurological Sciences and Pediatrics, Beckman Center for Molecular Medicine, Stanford University, Stanford, California; Lauren Krupp, MD, Director, NYU Langone Multiple Sclerosis Comprehensive Care Center, and Professor of Pediatric Neuropsychiatry, NYU Grossman School of Medicine, New York City; New England Journal of MedicineAugust 25, 2022



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