Phase 4 Study Dives into Real-World MS Outcomes with Teriflunomide

SEPTEMBER 15, 2016
Caitlyn Fitzpatrick
neurology, multiple sclerosis, MS, ECTRIMS 2016, pharmacy, teriflunomide
Studies tend to yield better results than those found in a real-world setting. So to find “real” clinical outcomes with teriflunomide in patients with multiple sclerosis (MS), researchers conducted a phase 4 trial and presented the findings at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2016) in London, England.

Teriflunomide is indicated for relapsing-remitting MS once per day. In addition to efficacy and safety profiles, the study set out to uncover quality of life outcomes.

The cohort consisted of 1,000 patients – of which, 594 switches from another disease-modifying therapy (DMT) within the previous six months and 285 had not been on a DMT for the previous two years. During this 48-week single-arm study, patients received teriflunomide 7 mg (US patients only) or 14 mg – administered depending on guidelines in the US, Canada, Europe, and Chile. Patients filled out the Multiple Sclerosis International Quality of Life (MusiQoL) Questionnaire to score different aspects of life from 0 to 100.

Scores were comparable at baseline and Week 48, with the median being 68.1 and 70.3, respectively. However, scores did slightly increase between the two time periods in three of the nine subscales.
  • Activities of daily living: 58.9 and 62.5
  • Psychological well-being: 62.5 and 68.8
  • Relationships with friends: 58.3 and 66.7
The median scores for the other six subscales – symptoms, relationships with family, sentimental and sexual life, coping, rejection, and relationship with healthcare system – remained stable from baseline to Week 48.

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