Teriflunomide Real-World Outcomes from the US Cohort of the Phase 4 Teri-PRO Study

Background: Teriflunomide is a once-daily oral immunomodulator for relapsing-remitting MS. Teri-PRO (NCT01895335), a global, prospective, single-arm, open-label study in patients with relapsing forms of MS, investigated patient-reported outcomes (PROs) and the effectiveness, safety, and tolerability of teriflunomide in routine clinical practice.

Objectives: To report PROs, effectiveness, safety, and tolerability for Teri-PRO patients enrolled in the US cohort.

Methods: Patients received once-daily teriflunomide 7 mg or 14 mg for 48 weeks, per US labeling. The primary outcome was global treatment satisfaction at Week 48, measured using the Treatment Satisfaction Questionnaire for Medication (TSQM, v 1.4). TSQM scores were measured at baseline (patients switching from a prior disease-modifying therapy [DMT] within the previous 6 months), and at Week 4 and Week 48/end of treatment (all patients). Secondary outcomes included Expanded Disability Status Scale (EDSS) score and annualized treated relapse rate. Adverse events (AEs) were reported at each study visit.

Results: A total of 545 patients from the US were included in Teri-PRO, of which 316 (58.0%) switched from another DMT. In the US cohort, mean (SD) age was 50.6 (10.5) years and mean (SD) time since first MS symptoms was 14.7 (9.8) years. Treatment satisfaction remained high over the study period (Global Satisfaction, mean [95% confidence interval, CI]: Week 4, 72.2 [70.4, 74.0]; Week 48, 67.9 [65.2, 70.6]). In switchers, Global Satisfaction significantly improved from baseline to Week 4, and then remained stable up to Week 48 (mean [95% CI]: baseline, 52.2 [49.1, 55.2]; Week 4, 74.9 [72.7, 77.1], P<0.0001; Week 48, 69.1 [65.6, 72.6], P<0.0001). Although mean (95% CI) baseline EDSS score for the US cohort (3.7 [3.6, 3.9]) was higher than the worldwide cohort (3.1 [2.9, 3.2]), scores remained stable over the course of the study (US cohort, Week 48, 3.7 [3.5, 3.9]). The mean treated relapse rate was also low over the course of the study (0.17). Treatment-emergent AEs and serious AEs were reported in 438 (80.4%) and 68 (12.5%) patients, respectively, and were of a mild to moderate intensity.

Conclusions: Overall, high levels of treatment satisfaction were observed, particularly in patients who switched from another DMT in whom treatment satisfaction had significantly improved. Effectiveness and safety outcomes in the US cohort were consistent with those observed in other teriflunomide clinical studies, with no new or unexpected AEs.