2 New Drugs May Fight Multiple Sclerosis
Study Shows Cladribine and Fingolimod Cut Relapse Rate in MS Patients
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Cladribine Cuts Relapse Rate
Compared with patients who were taking a placebo, those taking cladribine were 55% to 58% less likely to suffer a relapse in a year and 33% less likely to suffer worsening in their disability, such as having more trouble walking.
MRI scans showed that patients taking cladribine also had significantly fewer lesions in the deep parts of the brain or spinal cord that are characteristic of MS.
The drug was relatively safe. The most commonly reported side effects were headaches, colds and the flu, and nausea.
Still, the long-term concern is that "we need T cells to fight infections, particularly viral infections. So we'll have to keep an eye on this," Yung says.
"These results are really exciting," Giovannoni tells WebMD. "They have the potential to make a big difference in the lives of patients with MS."
Manufacturer Merck Serono, which funded the study, says it plans to seek FDA approval in the coming months.
Fingolimod Fights MS
Fingolimod also suppresses the autoimmune responses thought to cause MS, but in a different way. It's a molecule that locks T cells inside the lymph nodes, so they can't float around in the bloodstream and make their way to the brain and spinal cord. It was originally designed to help prevent organ rejection in kidney transplant patients, but that didn't work out very well, Jung says.
In that phase III study, more than 1,200 patients with the relapsing form of MS received one of two doses of fingolimod or Avonex daily for one year.
They suffered from the disease for an average of seven years, and all had an average of two relapses in the two years before entering the study.
Compared with patients who were taking Avonex, those taking fingolimod were 38% to 52% less likely to suffer a relapse in a year. They also had fewer new lesions and fewer lesions overall than those on the injectable drug.
The study wasn't long enough to show an effect on disability, says study head Jeffrey Cohen, MD, of the Cleveland Clinic.
The most common side effects were head colds, headache, and fatigue. But there were also eight cases of skin cancer and four cases of breast cancer. It is unclear whether the drug was responsible for the events.
Jung again cautions that longer-term data are needed. Fingolimod is a potent inhibitor of immune responses and patients are being watched carefully, she notes.
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.