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The study involved 231 people with a form of MS that's called relapsing-remitting. For these patients, there are times when their disease is very active. At other times, the condition becomes less intense and they may experience a full or partial recovery of function.
Researchers gave the participants either several low doses of a drug called ofatumumab or a harmless placebo pill. Ofatumumab is an "anti-B cell antibody" and is not yet approved for the treatment of MS. The research was funded by GlaxoSmithKline, the drug's maker.
Researchers led by GlaxoSmithKline investigator Darrin Austin analyzed the effects of this drug compared to the dummy pill on the total number of new brain lesions the patients developed over the course of 12 weeks.
The team compared the amount of B cells the participants had with the number of new brain lesions found on brain scans. Although all of the participants had lesion activity in the first four weeks, the study found that participants on any dose of anti-B cell therapy showed much less disease activity between the subsequent four- to 12-week period.
More specifically, when B cells were maintained below a certain threshold the appearance of new brain lesions was significantly reduced, the team said. On average, these participants had a rate of less than one new brain lesion per year, compared to an average of 16 lesions without treatment.
At least 5 percent of the study's participants developed side effects from the treatment over the course of the 12 weeks, including injection-related reactions, dizziness, anxiety, fever, respiratory tract infection and nerve pain.
"These results need to be validated, of course, but the findings are interesting," said Austin, who is based in Uxbridge, U.K. "They provide new insight into the mechanism of B cells in MS, and present a possible new target threshold for exploring the potential benefit of anti-B cell therapy."
Two experts in treating multiple sclerosis said the finds are intriguing.
"The data is very compelling with regard to ofatumumab's ability to limit new lesions accumulating in the brain," said Dr. Karen Blitz, director of the North-Shore LIJ Multiple Sclerosis Center in East Meadow, NY. However, she added that "further studies are needed to evaluate its effect on MS relapse rate and disability."
Dr. Fred Lublin is director of The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, at Icahn School of Medicine at Mount Sinai, in New York City. He said that if the findings were repeated in a larger study, the therapy "would be an important step forward in MS treatment."
The study was to be presented Thursday at the American Academy of Neurology's annual meeting in Philadelphia. Findings released at medical meetings are typically considered preliminary until published in a peer-reviewed journal.
-- Mary Elizabeth Dallas
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