Teriflunomide Slows Brain Atrophy in People With Relapsing MS

BARCELONA—Teriflunomide significantly slows brain-volume loss, compared with placebo, over two years in people with relapsing-remitting multiple sclerosis (MS), according to new data presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). In this analysis, researchers examined MRI data from the TEMSO study using Structural Image Evaluation Using Normalization of Atrophy (SIENA).

In the phase III TEMSO study, 1,088 participants with relapsing-remitting MS between ages 18 and 55 were randomly assigned to daily oral doses of placebo, 7 mg of teriflunomide, or 14 mg of teriflunomide for 108 weeks. The treatment arms were approximately equal in size, and randomization was stratified according to the baseline Expanded Disability Status Scale score and according to trial site, with a block size of six. Researchers regularly assessed the patients’ change in brain volume from baseline. The study’s primary end point was the annualized relapse rate, and the key secondary end point was confirmed progression of disability for at least 12 weeks. A total of 796 patients completed the study, with similar proportions of patients in the three study groups.

By month 12, median reduction from baseline in brain volume was 0.39%, 0.40%, and 0.61% for patients receiving 14 mg of teriflunomide, 7 mg of teriflunomide, and placebo, respectively. This change was lower for both teriflunomide groups, compared with placebo. For patients receiving 14 mg of teriflunomide, the change in volume was 36.9% lower than that for placebo. For patients receiving 7 mg of teriflunomide, the change in volume was 34.4% lower than that for placebo.

The significant difference in reduction of brain atrophy for teriflunomide versus placebo was maintained at month 24. Median reduction in brain volume from baseline was 0.90%, 0.94%, and 1.29% for 14 mg of teriflunomide, 7 mg of teriflunomide, and placebo, respectively. This change was lower for both teriflunomide groups versus placebo. For patients receiving 14 mg of teriflunomide, the change was 30.6% lower than that for placebo. For patients receiving 7 mg of teriflunomide, the change was 27.6% lower than that for placebo. In the MS clinical studies of teriflunomide, including TEMSO, the incidence of serious adverse events was similar between patients who received teriflunomide and those treated with placebo.

“Control or prevention of brain atrophy is an important target for MS treatment,” said Ludwig Kappos, MD, Chair of Neurology at University Hospital Basel in Switzerland. “These data help provide further insight into teriflunomide’s potential effects.”

BARCELONA—Teriflunomide significantly slows brain-volume loss, compared with placebo, over two years in people with relapsing-remitting multiple sclerosis (MS), according to new data presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). In this analysis, researchers examined MRI data from the TEMSO study using Structural Image Evaluation Using Normalization of Atrophy (SIENA).

In the phase III TEMSO study, 1,088 participants with relapsing-remitting MS between ages 18 and 55 were randomly assigned to daily oral doses of placebo, 7 mg of teriflunomide, or 14 mg of teriflunomide for 108 weeks. The treatment arms were approximately equal in size, and randomization was stratified according to the baseline Expanded Disability Status Scale score and according to trial site, with a block size of six. Researchers regularly assessed the patients’ change in brain volume from baseline. The study’s primary end point was the annualized relapse rate, and the key secondary end point was confirmed progression of disability for at least 12 weeks. A total of 796 patients completed the study, with similar proportions of patients in the three study groups.

By month 12, median reduction from baseline in brain volume was 0.39%, 0.40%, and 0.61% for patients receiving 14 mg of teriflunomide, 7 mg of teriflunomide, and placebo, respectively. This change was lower for both teriflunomide groups, compared with placebo. For patients receiving 14 mg of teriflunomide, the change in volume was 36.9% lower than that for placebo. For patients receiving 7 mg of teriflunomide, the change in volume was 34.4% lower than that for placebo.

The significant difference in reduction of brain atrophy for teriflunomide versus placebo was maintained at month 24. Median reduction in brain volume from baseline was 0.90%, 0.94%, and 1.29% for 14 mg of teriflunomide, 7 mg of teriflunomide, and placebo, respectively. This change was lower for both teriflunomide groups versus placebo. For patients receiving 14 mg of teriflunomide, the change was 30.6% lower than that for placebo. For patients receiving 7 mg of teriflunomide, the change was 27.6% lower than that for placebo. In the MS clinical studies of teriflunomide, including TEMSO, the incidence of serious adverse events was similar between patients who received teriflunomide and those treated with placebo.

“Control or prevention of brain atrophy is an important target for MS treatment,” said Ludwig Kappos, MD, Chair of Neurology at University Hospital Basel in Switzerland. “These data help provide further insight into teriflunomide’s potential effects.”

BARCELONA—Teriflunomide significantly slows brain-volume loss, compared with placebo, over two years in people with relapsing-remitting multiple sclerosis (MS), according to new data presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). In this analysis, researchers examined MRI data from the TEMSO study using Structural Image Evaluation Using Normalization of Atrophy (SIENA).

In the phase III TEMSO study, 1,088 participants with relapsing-remitting MS between ages 18 and 55 were randomly assigned to daily oral doses of placebo, 7 mg of teriflunomide, or 14 mg of teriflunomide for 108 weeks. The treatment arms were approximately equal in size, and randomization was stratified according to the baseline Expanded Disability Status Scale score and according to trial site, with a block size of six. Researchers regularly assessed the patients’ change in brain volume from baseline. The study’s primary end point was the annualized relapse rate, and the key secondary end point was confirmed progression of disability for at least 12 weeks. A total of 796 patients completed the study, with similar proportions of patients in the three study groups.

By month 12, median reduction from baseline in brain volume was 0.39%, 0.40%, and 0.61% for patients receiving 14 mg of teriflunomide, 7 mg of teriflunomide, and placebo, respectively. This change was lower for both teriflunomide groups, compared with placebo. For patients receiving 14 mg of teriflunomide, the change in volume was 36.9% lower than that for placebo. For patients receiving 7 mg of teriflunomide, the change in volume was 34.4% lower than that for placebo.

The significant difference in reduction of brain atrophy for teriflunomide versus placebo was maintained at month 24. Median reduction in brain volume from baseline was 0.90%, 0.94%, and 1.29% for 14 mg of teriflunomide, 7 mg of teriflunomide, and placebo, respectively. This change was lower for both teriflunomide groups versus placebo. For patients receiving 14 mg of teriflunomide, the change was 30.6% lower than that for placebo. For patients receiving 7 mg of teriflunomide, the change was 27.6% lower than that for placebo. In the MS clinical studies of teriflunomide, including TEMSO, the incidence of serious adverse events was similar between patients who received teriflunomide and those treated with placebo.

“Control or prevention of brain atrophy is an important target for MS treatment,” said Ludwig Kappos, MD, Chair of Neurology at University Hospital Basel in Switzerland. “These data help provide further insight into teriflunomide’s potential effects.”