Thursday, August 25, 2022 (HealthDay News) — An experimental treatment with antibodies to multiple sclerosis It can cut symptom flare-ups by half, versus the new standard treatment Clinical trial have been found.
This drug, called ublituximab, is superior to the standard oral MS drug in reducing patients’ relapses — periods of new or worsening symptoms. It has also been shown to be better at blocking 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 trial data and is expected to make a decision by the end of the year, according to drug maker TG Therapeutics.
If approved, ublituximab will be the latest in a new group of MS treatments called anti-CD20 . monoclonal antibodiesLab-designed antibodies that target specific cells of the immune system that drive the process of multiple sclerosis.
The new findings provide more evidence that this approach benefits patients, according to an expert who was not involved in the trial.
“Is this revolutionary?
MS is a neurological disorder that usually arises between the ages of 20 and 40. It is caused by a misleading immune system It attacks the body’s own myelin – the protective sheath around nerve fibers in the spine and brain. Depending on where the damage occurred, symptoms include vision problems, muscle weakness, numbness, and difficulty with balance and coordination.
Most people with MS experience a relapsing and relapsing form, in which symptoms worsen for a while, then subside. Over time, the disease becomes steadily more advanced.
Immune system cells called B cells seem to play a particularly key role in driving MS. Recent years have seen the development of monoclonal antibodies that deplete the blood of B cells. One, called ocrelizumab (Ocrevus), was approved in the United States in 2017. The second — ofatumumab (Kesimpta) — followed in 2020.
Both antibodies deplete B cells by targeting a protein on the cells called CD20. Ublituximab has the same goal, but is designed to be more effective at killing B cells, said Dr. Lawrence Steinmann, lead researcher on the new trial.
Steinman, a professor of neuroscience at Stanford University, emphasized that the trial did not compare ublituximab with any of the current anti-CD20 antibodies. So it is not known if it is more or less effective.
But Steinman said the potential advantage of the new antibody is that it can be taken up quickly.
Both Ocrevus and ublituximab require patients to go to a medical facility for an injection every six months. But the Ocrevus injection takes about three hours, while ublituximab can be given within one hour.
Meanwhile, Kisembta avoids injections completely. 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.”
The results published on August 25 in New England Journal of Medicine , are based on more than 1,000 patients with MS, most of whom are of the relapsing-remitting and relapsing form. A small proportion had secondary progressive MS, a second stage of the disease that follows years of relapse and remission.
About half were randomly assigned to infusions of ublituximab, while the other half took the oral drug Aubagio (teriflunomide).
Over the course of 96 weeks, obltuximab patients were half as likely to relapse – with an annual mean of just under 0.1, versus about 0.2 among the Aubagio patients. And on MRI scans, they showed fewer areas 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 it can make people more susceptible to infection. This was the case in this trial: 5% of ublituximab patients developed serious infections, including pneumonia, versus 3% of Aubagio patients.
There are many medications approved to treat MS. But Krupp said some recent studies show that patients improve in the long term when they get “high potency” drugs — which include anti-CD20 antibodies — versus older drugs with milder effects.
For Steinman, earlier is better when it comes to starting a highly effective treatment.
“My philosophy is if insurance is going to cover it, drop the disease hard and fast,” he said.
This begs the real cost issue: CD20 monoclonal antibodies are expensive; The current list price for Ocrevus is about $68,000 a year, according to pharmaceutical company Genentech.
Often, Krupp and Steinman said, drug decisions depend on what is covered by a patient’s insurance plan.
The National Multiple Sclerosis Society has more on treating MS.
SOURCES: Lawrence Steinman, MD, director and professor, Neurology, Neurosciences and Pediatrics, Beckman Center for Molecular Medicine, Stanford University, Stanford, CA; Lauren Krupp, MD, director of the Comprehensive Care Center for Multiple Sclerosis at NYU, and Professor of Pediatric Neuropsychiatry, NYU Grossman School of Medicine, New York; New England Journal of MedicineAugust 25, 2022