Ofatumumab has not been government-approved for medical use in MS patients anywhere in the world.
"Ask your doctor about treating multiple sclerosis."
The study’s lead author was Daren Austin, PhD, of GlaxoSmithKline, a pharmaceutical company based in Uxbridge, United Kingdom.
The study investigated what happens when MS patients are injected with ofatumumab, which GlaxoSmithKline created to treat a certain form of leukemia.
Still, these researchers wrote that they were trying to determine how ofatumumab might affect B cells, which help fight off infection. Those B cells are believed to play a role in MS, a disorder in which the immune system attacks parts of the central nervous system. Symptoms of that resulting autoimmune disorder include extreme exhaustion, difficulty getting around physically, numbness in the limbs and loss of vision.
For this investigation, 231 people with relapsing-remitting MS — meaning their symptoms appear and disappear in cycles — were randomly selected to either receive injections of ofatumumab or of a placebo containing no medicine at all.
For 24 weeks, the researchers monitored all these patients. For the first 12 weeks, the researchers did brain scans every four weeks to determine whether any patients developed new brain lesions. Those abnormal lesions on the brain are signs of MS, the researchers wrote.
Patients taking the placebo and those taking the ofatumumab did have new lesions during the first four weeks of the study. However, between the fourth and twelfth weeks, the brain scans of those taking ofatumumab showed no new lesions, the researchers found.
These researchers also measured study participants' B cells. When the amount of B cells fell to a specific, minimum level, the appearance of those new brain lesions changed. That meant these patients' MS symptoms were “significantly reduced,” the researchers wrote.
MS patients in this study whose B cells remained at that minimum threshold could be projected to develop one new brain lesion per year while taking ofatumumab, the researchers wrote. If they did not take the medication, they were projected to develop 16 lesions per year.
“These results need to be validated, of course, but the findings are interesting,” Dr. Austin said in an announcement about this preliminary study. “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 [ofatumumab] therapy.”
The treatment did have some side effects. From the first week to the twelfth week, 5 percent of patients got dizzy, anxious or feverish or had nerve pain or a respiratory tract infection as a result of being injected with ofatumumab.
In other words, those who received ofatumumab had twice the rate of side effects as those who were injected with the placebo.
Given those side effects, "the results of this study are both encouraging and discouraging at the same time," Steve Leuck, PharmD, president and owner of AudibleRx, told dailyRx News.
"Research in this study shows a potentially major breakthrough in the treatment of multiple sclerosis," Dr. Leuck said. "However, as this study shows, breakthroughs in medical treatment [can] come with the price of unknown side effects. Whenever we use a medication to help fight how the body responds to an autoimmune disease, we also compromise the entire immune system, which may lead to further complications."
Results of this preliminary study are slated to be released during the American Academy of Neurology’s 66th Annual Meeting, April 26 to May 3, 2014 in Philadelphia.
GlaxoSmithKline funded this research.