Outcomes in the African-American Subpopulation from the Phase 4 Teri-PRO Study of Teriflunomide

Background: Teriflunomide is a once-daily oral immunomodulator approved for relapsing-remitting MS. The global, prospective, phase 4 Teri-PRO study (NCT01895335) evaluated patient-reported outcomes (PROs), effectiveness, safety, and tolerability of teriflunomide in a real-world setting. Teri-PRO enrolled a number of African-American (AA) patients. Given that AA patients tend to have a poorer prognosis than Caucasian patients, we evaluated treatment outcomes in this population enrolled in Teri-PRO.

Objectives: To report PROs and other treatment outcomes in the AA population of the Teri-PRO study.

Methods: Patients with relapsing forms of MS in Teri-PRO received teriflunomide 7 mg or 14 mg, per local labeling. The primary outcome was Global Satisfaction at Week 48 (W48), measured using the Treatment Satisfaction Questionnaire for Medication (TSQM; v1.4). TSQM was measured at baseline (patients switching from prior disease-modifying therapy [DMT] only), and Week 4 (W4) and W48/end of treatment (all patients). Secondary outcomes presented here include Expanded Disability Status Scale (EDSS) score and annualized treated relapse rate.

Results: For the US-based AA patients in Teri-PRO (n=49), mean (SD) age was 45.0 (10.9) vs 50.6 (10.5) years for all US patients (N=545), and time since first MS symptoms was 11.2 (8.2) vs 14.7 (9.8) years. For AA patients, mean (95% CI) TSQM Global Satisfaction scores for W4/W48 were 69.9 (63.6, 76.2)/64.3 (55.1, 73.5). In AA patients switching from another DMT (n=27), statistically significant increases in mean (95% CI) Global Satisfaction scores from baseline were reported at W4 and maintained at W48; baseline/W4/W48: 50.0 (40.1, 59.9)/74.0 (65.7, 82.3), P<0.0001/73.6 (65.7, 81.5), P=0.0001. Baseline mean (95% CI) EDSS score was similar (3.6 [3.0, 4.2]) to the US cohort (3.7 [3.6, 3.9]) and remained stable over the treatment period (W48: 3.7 [3.0, 4.5]). Relapse rate was higher in this group (0.35 in all patients, 0.50 in switchers) vs the overall US Teri-PRO population (0.17 in all patients, 0.21 in switchers).

Conclusions: AA patients with MS are known to exhibit a more aggressive disease course, which is supported by the higher relapse rate observed in the AA cohort of Teri-PRO. Despite this, AA patients reported high levels of treatment satisfaction with teriflunomide, with significant increases in those switching from other DMTs, consistent with the overall Teri-PRO study cohort.