High levels of satisfaction with the efficacy and convenience of Aubagio (teriflunomide), an oral treatment for relapsing multiple sclerosis (MS), were reported by patients across the U.S. and 13 other countries, a post-hoc analysis of data from a real-world Phase 4 study found.
The study “Teriflunomide real-world evidence: Global differences in the phase 4 Teri-PRO study” was published in the journal Multiple Sclerosis and Related Disorders.
A post-approval and -marketing clinical study called Teri-PRO (NCT01895335) assessed patient satisfaction with Aubagio — by Sanofi Genzyme— a once-daily immunomodulator for people with relapsing-remitting MS and secondary progressive MS with relapses.
Previous studies based on data from the Teri-PRO trial showed satisfactory results associated with the therapy, and stable disability scores between the study’s start (called its baseline) and its end about two years later.
But because of differences in treatment guidelines, approvals, availability, and prescribing practices among countries, reported results may not have not reflected such differences.
For this reason, researchers compared patient-reported outcomes from the Teri-PRO trial between the U.S. and other participating countries.
In total, they analyzed data from 14 countries. The study compared 545 MS patients in the U.S. (mean age of 50.6 years), and 455 patients in Canada and 12 European countries (mean age of 42.9 years). Those outside the U.S. were placed in a group titled “rest of world” or ROW. People in this group also had a shorter mean time since MS symptom onset than those in the U.S. (11.3 vs.14.7 years) , the study reported, and lower mean Expanded Disability Status Scale (EDSS) scores at baseline (3.7 vs. 2.2).,
The study’s primary goal was treatment satisfaction after two years of Aubagio use, as measured using the Treatment Satisfaction Questionnaire for Medication (TSQM). Secondary goals included changes between the study’s start and end in disability and cognitive impairments, and reported side effects.
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