Teriflunomide Reduces Active Lesions in MS Patients

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NEW YORK (Reuters Health) Apr 21 - Treatment with teriflunomide, an oral dihydro-orotate dehydrogenase inhibitor, reduces disease activity with a trend towards fewer relapses in patients with multiple sclerosis (MS), according to the results of a phase II trial conducted by North American and European investigators.

Lead researcher Dr. Paul W. O'Connor told Reuters Health: "These findings are exciting in that they move us one step further to developing something that all MS patients on therapy want: an effective oral treatment."

All current MS drugs require administration by injection. However, teriflunomide, which can be given orally, has shown promise in animal models of autoimmune disease, Dr. O'Connor of St. Michael's Hospital, Toronto and colleagues note in the March 28th issue of Neurology.

To investigate further, the researchers studied 157 patients with relapsing-remitting MS and 22 with secondary progressive MS with relapses. The patients were randomized to 36 weeks of teriflunomide 7mg/day, 14 mg/day or placebo. MRI scans were conducted every 6 weeks.

MRI showed that the median number of combined unique active lesions per scan was 0.5 in the placebo group, 0.2 in the 7-mg group and 0.3 in the 14-mg group.

Patients in both teriflunomide groups had significantly fewer T1 enhancing lesions per scan, new or enlarging T2 lesions per scan and new T2 lesions. Patients in the higher-dose group also had a significantly reduced T2 disease burden.

Compared with placebo, significantly fewer patients in the higher-dose group showed a disability increase. These patients also showed a trend towards a lower annualized relapse rate and there were fewer relapsing patients. The treatment was well tolerated and the frequency of adverse events was similar across groups.

"A full phase III trial of this therapy will be necessary to establish a clinical benefit, and this is in progress at present in Canada, Europe, Australia and South Africa," Dr. O'Connor said.

Neurology 2006;66:894-900.

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Reuters Health Information 2006. © 2006 Reuters Ltd.
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