Phase IV Study Reports Multiple Sclerosis Success with Teriflunomide

OCTOBER 07, 2015
Caitlyn Fitzpatrick
The results from an on-going phase 4 trial add to the growing evidence that teriflunomide is effective for relapsing-remitting multiple sclerosis, according to Patricia K. Coyle, MD, of Stony Brook University in New York.

Teriflunomide is an oral immunomodulatory which is approved to be taken once a day for patients with relapsing forms of multiple sclerosis (RMS). Time and time again it has proven to display benefits against a placebo in clinical trials. Coyle and her colleagues are scheduled to present their analysis in a poster session at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2015) in Barcelona, Spain.

A total of 1,001 patients with RMS are included in the Teri-PRO global study, but this specific section of the analysis consisted of 545 Americans (76% female) with an average age of 50.6. Of those, 473 (86.8%) received 14 mg of teriflunomide and the other 72 (13.2%) took 7 mg once a day for 48 weeks. Notably, 385 patients (70.6%) had used at least one other disease-modifying therapy (DMT) within two years before the start of the study, and the average baseline Expanded Disability Status Scale score was 3.74 (standard deviation of 1.94). Halfway through the research, 463 patients out of the original 545 were still enrolled.

From baseline to week 24, the following changes were observed in patients who switched from another DMT to teriflunomide within six months of the start of the study:
  • Treatment Satisfaction Questionnaire for Medication (TSQM): 52.2 vs 74.9 (22.7 improvement)
  • Multiple Sclerosis Performance Scale (MSPS): 13.4 vs 14.1 (0.7 improvement)
The team noted that 384 patients (70.5%) reported an adverse effect, and 49 (9%) left the study as a result.

“In this real-world clinical practice study, interim results illustrate that teriflunomide is associated with high levels of treatment satisfaction and a substantial increase in satisfaction in patients who switched to teriflunomide from other DMTs,” the authors verified.


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