New MS Therapies Show Promise

(HealthDay News) -- Two medications may prove to be advances in the treatment of multiple sclerosis, researchers say.

In one study, an experimental drug called oral fumarate (BG00012) substantially reduced symptoms in patients with relapsing-remitting multiple sclerosis, according to a phase II clinical trial by European and North American researchers.

And in a second trial, researchers found that the leukemia drug alemtuzumab (Campath) was about 70 percent more effective than another drug already widely used to treat MS. However, alemtuzumab also had significant side effects, including bleeding disorders, a greater risk of thyroid disease, and infections. This prompted experts to say that much more research is needed before alemtuzumab can be prescribed to treat multiple sclerosis.

Multiple sclerosis is a nervous system disease that affects the brain and spinal cord. It damages the myelin sheath, the material that surrounds and protects nerve cells. This damage slows or blocks messages between the brain and the body, according to the U.S. National Library of Medicine.

Symptoms of the disease can include visual disturbances; muscle weakness; trouble with coordination and balance; sensations such as numbness, prickling, or "pins and needles;" and thinking and memory problems.

It's not known what causes multiple sclerosis. It may be an autoimmune disease, which happens when the body attacks itself. MS affects women more than men, and it often begins between the ages of 20 and 40. An estimated 400,000 Americans have the disease. Usually, the disease is mild, but some people lose the ability to write, speak or walk. There's no cure for MS, but medicines may slow it down and help control symptoms, according to the National Library of Medicine.

The 24-week study of BG00012 included 257 patients, ages 18 to 55, who were randomly assigned to receive either 120 milligrams of BG00012 once a day (64 patients), 120 milligrams three times a day (64 patients), 240 milligrams three times a day (64 patients), or a placebo (65 patients). The patients were assessed at weeks 12, 16, 20 and 24.

MRI brain scans showed that patients treated with 240 milligrams of BG00012 three times a day had 69 percent fewer new gadolinium enhancing (GdE) lesions -- a marker of MS-related inflammatory activity -- from week 12 to 24 than those who received the placebo. They also had fewer new or enlarging T2-hyperintense and T1-hypointense lesions at week 24.

The study also found that BG00012 reduced the annual relapse rate by 32 percent, but this finding wasn't statistically significant. Patients who received the drug were more likely than those in the placebo group to suffer adverse events such as abdominal pain and hot flush. Dose-related adverse events in patients taking the drug included headache, fatigue and feeling hot, the researchers said.

"Longer-term (phase III) studies of BG00012 in larger patient populations are underway to define its place in the future of relapsing-remitting multiple sclerosis treatment. If these studies show similar relapse rate reductions with BG00012, interferon beta, and glatiramer acetate, BG00012 could be a suitable initial treatment for relapsing-remitting multiple sclerosis," wrote Professor Ludwig Kappos, of University Hospital Basel, in Switzerland, and colleagues.

The study was published in the Oct. 24 issue of the The Lancet.

In an accompanying comment in the journal, Professor Per Soelberg Sorensen and Dr. Finn Sellebjerg of the Danish Multiple Sclerosis Research Center, noted that "BG00012 might have a favorable benefit-to-risk ratio profile compared with its oral competitors and the currently available first-line injectable drugs. However, we will have to await the results from the ongoing large phase III trials to establish the place of BG00012 and of other oral drugs in the treatment of relapsing-remitting multiple sclerosis."

The study of the leukemia drug alemtuzumab, which temporarily depletes white blood cells and is part of a class of drugs called monoclonal antibodies, included 334 patients. Patients were randomly assigned to get either alemtuzumab or interferon beta, a standard MS therapy, for three years.

Alemtuzumab reduced by 74 percent the risk of MS relapse, the researchers reported in the Oct. 23 issue of the New England Journal of Medicine.

"The ability of an MS drug to promote brain repair is unprecedented," Alasdair Coles, of Cambridge University in England, and one of the study's leaders, told the AFP news service. "We are witnessing a drug which, if given early enough, might effectively stop the advancement of the disease and also restore lost function by promoting repair of the damaged brain tissue."

However, in an accompanying journal editorial, Dr. Stephen L. Hauser, a neurologist at the University of California, San Francisco, said the "toxic effects associated with alemtuzumab considerably dampen any enthusiasm for its routine use in patients with multiple sclerosis until more is known about its long-term safety and sustained efficacy."

More information
The U.S. National Institute of Neurological Disorders and Stroke has more about multiple sclerosis.

MS Patients at Higher Risk for Restless Legs Syndrome

(HealthDay News) -- People with mltiple sclerosis is are at a greater risk than the general population for developing rstless legs syndrome (RLS), a new Italian study suggests.

"This is important, because RLS is one of the symptoms that can seriously affect an MS patient's quality of life, even more than a lot of other problems MS patients face," said lead researcher Dr. Giovanni Cossu, a neurologist at Brudzu Hospital in Cagliari, Italy. "Therapies for RLS [such as] dopamine agonists are normally very effective and can restore this quality of life, " he added.

Cossu and his colleagues were expected to present their findings this week at the Movement Disorder Society's International Congress of Parkinson's disease and Movement Disorders, in Chicago.

The authors delved into a possible association between MS and RLS by analyzing questionnaires completed by a little more than 200 Italian male and female MS patients throughout 2007, as well as a similar number of people without MS.

Those indicating symptoms of possible RLS were further examined by a neurologist.

According to the study, almost 15 percent of the MS patients were diagnosed with RLS, while less than 3 percent of those without MS had the syndrome.

Based on these results, MS patients run a significantly higher risk for RLS than the general population, the team concluded. They said MS should be "definitively" noted as being highly associated with RLS.

Cossu said that further research -- focused on crunching MRI and neurological data -- is ongoing in order to "better define the clinical profile of those MS patients who are also likely candidates for RLS."

However, Dr. John Richert, executive vice president of research and clinical programs with the National Multiple Sclerosis Society, New York City, expressed some reservations about the findings.

"A lot of people with MS have involuntary movement of the legs, related to spasticity and jerks during sleep," he observed. "So, my question would be whether or not there is any confusion on the part of the investigators as to what is actually RLS versus what is the kind of abnormal movement that MS patients can have that is not RLS? And so, it would be important to see this study replicated by MS experts to be sure what were looking at."

"But if we assume that this finding is, in fact, accurate, then the obvious message would be that health care professionals taking care of patients with MS need to be alert to the possibility that their patients may be experiencing symptoms of RLS," added Richert. "And be ready to apply the appropriate therapeutic options."

More information
There's more on restless legs syndrome at the RLS Foundation.