Studies Find Two New Drugs Reduce Relapses of Multiple Sclerosis

Two new drugs have been shown to slash by as much as half the rate of relapse in people with multiple sclerosis (MS), according to researchers.

The drugs, cladribine and fingolimod, are oral medications already approved for other treatments. If given the go-ahead by the Food and Drug Administration to treat MS, they would become the first treatments for that disease which do not require regular infusions or injections. Many MS sufferers either cannot or do not want to inject drugs to treat the condition.

Recent studies have found the drugs are effective in keeping MS sufferers relapse-free for years compared to other treatments. The findings recently were presented at the annual meeting of the American Academy of Neurology.

In one study, about 80 percent of MS patients taking the chemotherapy drug cladribine avoided relapse, compared to just 61 percent of patients who were given placebo.

Another study found that between 80 percent and 84 percent of people taking fingolimod, an immune-suppressing drug, were relapse-free one year after treatment, compared to 67 percent who were taking the standard MS drug Avonex, researchers said.

Cladribine (Leustatin) Lowers Relapse Rate

Cladribine, the generic form of the Ortho Biotech Products LP leukemia drug Leustatin, suppresses the autoimmune responses which are thought to cause MS. The drug prevents T cells from reproducing and attacking the myelin sheaths that surround and protect brain cells.

In the clinical study of the drug, MS patients taking cladribine were 55 percent to 58 percent less likely to suffer a relapse of the disorder within a year compared to others given placebo pills. They also were one-third less likely to have more difficulty walking or develop other worsening of their conditions, the researchers said.

Also, MRI scans showed that MS patients taking cladribine had significantly fewer lesions in the deep parts of the brain or spinal cord, which are a sign of MS.

Another benefit of using cladribine to treat MS was that the drug appears safe, with side effects including headaches, colds and the flu, and nausea. Merck, the drug company behind cladribine, reportedly expects to seek FDA approvals for the drug to treat MS sometime in 2009.

Fingolimod Suppresses Immune System to Fight MS

Fingolimod, made by Novartis, suppresses the autoimmune responses suspected of causing MS like cladribine, but in a different way. The drug is a molecule that contains T cells inside the lymph nodes, preventing them from entering the bloodstream and reaching the brain and spinal cord, researchers said.

In a study of more than 1,200 MS patients, people taking fingolimod were 38 percent to 52 percent less likely to suffer a relapse in a year, compared to others taking the MS drug Avonex. Fingolimod patients also had fewer lesions than those using Avonex.

Two other large studies of fingolimod are still ongoing, with results expected later this year. Drugmaker Novartis, which funded the current trial, hopes to apply for FDA approval by the end of 2009.

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