Baseline Characteristics of Patients Enrolled in the Teri-PRO Phase 4 Study in the United States Vs Canada, Europe, and Latin America

Background: Teriflunomide is a once-daily oral immunomodulator that has shown consistent efficacy in phase 3 studies in patients with relapsing forms of multiple sclerosis (RMS). It has a well-characterized safety profile. The ongoing, global phase 4 Teri-PRO study (NCT01895335) is examining efficacy and tolerability of, and satisfaction with, teriflunomide in routine clinical practice using patient-reported outcomes (PROs) in patients with RMS.

Objectives: To describe demographics and baseline disease characteristics of patients enrolled in Teri-PRO in the USA and rest of the world (ROW).

Methods: Teri-PRO is a prospective, single-arm, open-label study in 1001 patients with RMS receiving once-daily teriflunomide 14mg or 7mg for 48 weeks, with doses given according to local labeling in Europe, North America, and Latin America. Primary outcome is global satisfaction, measured by scores on the Treatment Satisfaction Questionnaire for Medication (version 1.4) assessed at 48 weeks (or end of treatment). Secondary outcomes include other PRO metrics over the study period, relapse and disability assessment, and safety.

Results: Enrollment within the USA is complete: 609 patients were screened, and 545 included in the study; 472 (86.8%) and 72 (13.2%) received teriflunomide 14mg and 7mg, respectively. Mean (SD) age was 50.7 (10.5) years; 76.1% were female. Mean (SD) time since first symptom was 14.7 (9.7) years, baseline mean (SD) Expanded Disability Status Scale (EDSS) score was 3.74 (1.95), and 70.8% reported use of ≥1 disease-modifying therapy (DMT) in the last 2 years.

As of November 14, 2014 (recruitment ongoing), 391 ROW patients (Canada, Europe, and Latin America) had been screened, 369 were included in the study, and 334 had begun receiving teriflunomide 14mg. Mean (SD) age was 42.6 (10.0) years; 72.5% of patients were female. Mean (SD) time since first symptom was 11.2 (8.7) years, baseline mean (SD) EDSS score was 2.29 (1.57), and 70.7% reported use of ≥1 DMT in the last 2 years.

Enrollment was completed on December 5, 2014. Data on all included patients (N=1001) will be presented in the poster.

Conclusions: Teri-PRO will provide valuable information on the use of teriflunomide in routine clinical practice, including patient treatment satisfaction, safety, and efficacy. Comparison of baseline characteristics indicate some differences between US patients and those from other regions, which may reflect differences in prescribing practices and overall disease management.