Teriflunomide real-world evidence: Global differences in the phase 4 Teri-PRO study

Area of Science:

• Neurology
• Immunology
• Pharmacology

Background:

• Multiple sclerosis (MS) patient demographics and management vary globally, potentially impacting treatment outcomes.
• Real-world data on teriflunomide use and its effectiveness across different geographical regions are limited.
• The Teri-PRO study investigated teriflunomide in relapsing MS patients across the US and ROW.

Purpose of the Study:

• To compare teriflunomide use and patient-reported outcomes (PROs) between the United States (US) and the rest of the world (ROW).
• To assess treatment satisfaction and disease status in MS patients receiving teriflunomide in a real-world setting.
• To explore potential differences in teriflunomide effectiveness based on geographical variations.

Main Methods:

• A post-hoc analysis of the phase 4, real-world Teri-PRO study (NCT01895335) involving patients with relapsing MS treated with teriflunomide for 48 weeks.
• Primary endpoint: Treatment satisfaction assessed by the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4).
• Secondary endpoints: Expanded Disability Status Scale (EDSS), Multiple Sclerosis Performance Scale (MSPS), Patient-Determined Disease Steps (PDDS), and adverse events (AEs). Exploratory analysis of Black patients.

Main Results:

• The US cohort (n=545) and ROW cohort (n=455) showed significant differences in baseline age, disease duration, and EDSS scores (all p<0.0001).
• Black patients comprised 9% of the US cohort versus 0.2% of the ROW cohort.
• Significant improvements in TSQM scores (global satisfaction, effectiveness, convenience, side effects) were observed from baseline to Week 48 (all p<0.0001) in both groups. Disability measures remained stable.
• AEs were similar between groups; hair thinning was reported less frequently in the US (16.1%) vs ROW (31.2%). Black patients showed comparable PRO changes to the overall US group.

Conclusions:

• Baseline demographic and clinical differences between US and ROW patients suggest variations in teriflunomide prescribing practices.
• Teriflunomide demonstrated comparable improvements in treatment satisfaction and stable disability measures in both US and ROW patient groups.
• The findings suggest teriflunomide is effective across diverse geographical regions, irrespective of baseline differences and potential cultural or management variations.