Early Results Promising for MS Drug
Multiple Sclerosis Patients on Oral Drug Fingolimod Had Few Relapses
Trapping T Cells continued...
In the patients switched from a placebo to fingolimod, the relapse rate was reduced by at least 70% during the second six-month study phase, compared with the first six months on a placebo.
The researchers also reported that the number of MS-related brain lesions seen on MRI scans was much lower in the actively treated patients than among those on a placebo.
Among the 227 patients who remained in the trial for a year, brain lesions and relapse rates remained low in the group taking fingolimod the entire time, and lesions and relapse rates decreased with active treatment in the group switched from a placebo.
Although fingolimod was well tolerated by most patients, the drug's long-term safety in the treatment of MS will not be known until studies that include thousands of patients are complete, Harvard University professor of pathology Ulrich von Andrian, MD, tells WebMD.
The most common side effects reported in fingolimod users included shortness of breath, inflammation of the nose and throat, headache, diarrheadiarrhea, and nausea. Fingolimod users also had more cases of elevation in a liver enzyme test. More adverse side effects were noted in the group receiving the higher dose of fingolimod. One case of a serious neurological syndrome was reported in a 52-year-old woman taking the 5-milligram dose for 10 weeks. Although she had improvement of symptoms after the drug was stopped, she had some residual effects after 15 months.
Concerns about the MS drug Tysabri, which acts in a different way to suppress the immune system, led to an FDA warning earlier this year. The drug was temporarily withdrawn from the market early in 2005 after three patients developed a rare and serious brain disease.
In an editorial accompanying the study, von Andrian wrote that long-term suppression of the migration of T cell lymphocytes could have "undesired consequences."
Enrollment for a worldwide phase III trial of fingolimod to include around 2,000 MS patients, began in June.
Novartis spokeswoman Denise Brashear tells WebMD that if all goes well in the phase III studies, the company hopes to petition the FDA by 2009 to approve the drug for sale in the U.S.