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.
Results showed that global satisfaction significantly increased between baseline and the two-year time point in both the U.S. and the ROW group. High TSQM scores were also seen in all three of the questionnaire’s sub-categories — treatment effectiveness, perceived side effects, and convenience of use. The ROW group, however, showed a greater mean change in satisfaction linked to side effects than did the U.S. group.
To assess and compare disability scores, researchers used three different established scales, including EDSS, which assesses such functions as muscle strength, balance, cognitive abilities, vision, and bowel and bladder control. They found that MS patients in the U.S. had higher disability at baseline compared with the ROW group in all three scales used. But mean scores were stable between study start and its two-year conclusion in both groups.
Results also showed that U.S. patients had higher rates of cognitive impairment scores at baseline compared with those in ROW. Still, similar to the disability scores, no significant difference between the two groups when analyzing changes in cognition scores between the study’s start and end. In other words, disability scores were stable throughout the study.
Patients in both groups were similar in reports of experienced side effects with Aubagio use — 80.4% and 84.6% in the U.S. and ROW groups, respectively. Most of these adverse effects were also found to be mild among the two groups (62.4% in the U.S. and 72.3% in ROW group).
The most common side effects reported by U.S patients and those elsewhere included hair-thinning (16.1% and 31.2%, respectively), diarrhea (15.8% and 19.1%), and nausea (9.2% and 7%).
Thinning hair, the main adverse effect of treatment, rarely led to discontinuation (0.9% in both groups), and few of these cases were considered severe (0.7% in the U.S., 1.1% in the ROW), the analysis found.
Black patients were part of a subgroup analysis — they were 9% of the U.S. group and 0.2% of ROW — and no significant differences in patient-reported outcomes were found.
An “improvement in treatment satisfaction and stability of disability measures were comparable between patients in the U.S. and ROW” groups, the researchers concluded. Aubagio, they added, is an effective therapy “despite differences in baseline demographics and possible cultural and management differences between these geographical regions.”
Given that “the progression of clinical and cognitive disability in MS can significantly impact a patient’s quality of life … treatment satisfaction is therefore an important consideration for physicians when selecting a medication,” they noted.
Six of the 10 researchers conducting this study reported not receiving any “honoraria” (financial support) for this work; the four others were employees of Sanofi Genzyme or Sanofi.
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