TEMSO publication reveals teriflunomide benefits in MS patients
MedWire News: Teriflunomide treatment reduces the rate of relapse and progression of disability among patients with multiple sclerosis (MS) relative to placebo treatment, show the TEMSO results.
The full findings of the randomized TEMSO (Teriflunomide MS Oral) trial appear in this week's issue of the New England Journal of Medicine. It involved 1088 patients with MS who were aged between 18 and 55 years, had a score of no more than 5.5 on the Expanded Disability Status Scale (EDSS), and had at least one relapse in the year before enrollment or at least two relapses in the 2 years before enrollment.
The patients underwent treatment for 108 weeks, during which time those randomly assigned to take a daily placebo tablet had an annualized relapse rate of 0.54. By contrast, patients taking teriflunomide 7 mg had a relapse rate of 0.37, as did those taking teriflunomide 14 mg.
The relative risk reductions were 31.2% for teriflunomide 7 mg and 31.5% for teriflunomide 14 mg versus placebo. Also, the proportion of patients with an increase of at least 1.0 on the EDSS that lasted at least 12 weeks was significantly smaller in the teriflunomide groups versus the placebo group, at 21.7% and 20.2% with teriflunomide 7 and 14 mg, respectively, compared with 27.3% with placebo.
"The magnitude of the benefits observed in patients receiving teriflunomide was modest, but similar to those reported for the existing injectable disease-modifying therapies approved for use in patients with multiple sclerosis," say Paul O'Connor (University of Toronto, Ontario, Canada) and colleagues.
Adverse events occurred in similar proportions of all treatment groups, but diarrhea, nausea, and hair thinning or decreased hair density were more common among patients treated with teriflunomide versus placebo.
Elevated liver enzymes occurred in 12.0% and 14.2% of the teriflunomide 7 and 14 mg groups, respectively, compared with 6.7% of the placebo group.
The investigators also studied the effect of teriflunomide treatment on magnetic resonance imaging (MRI) markers of MS. Changes in the key marker - total lesion volume - were significantly less with teriflunomide than with placebo, at 1.31 and 0.72 ml increases for the teriflunomide 7 and 14 mg doses, respectively, compared with a 2.21 ml increase for placebo.
O'Connor et al note that there was a possible dose response for the effect of teriflunomide on this outcome, as was the case for several other MRI measures and also for progression of disability.
"The findings from our phase III study suggest that teriflunomide is an effective new oral monotherapy for relapsing multiple sclerosis," they conclude.
By Eleanor McDermid