Vitamin D and healthcare utilization during long-term treatment with fingolimod in relapsing-remitting multiple sclerosis: PASSAGE world-wide Post-Approval Safety program

Background: PASSAGE is a prospective, multinational study to evaluate long-term (>5 years) safety in relapsing MS patients newly started with fingolimod or receiving another disease-modifying therapy (DMT) in routine medical practice. Methods: The parallel-cohort study will compare patients treated with fingolimod or another DMT. Canadian sub-studies will assess the relationship between serum 25(OH)D levels (including dosage) and disease activity in both treated cohorts, and the effect of fingolimod on healthcare resource utilization (e.g. steroid use, hospitalizations). Patient-reported outcomes will include disability, health-related quality of life and productivity. Results: At last data cut-off, 470 MS patients (mean age 41.5 years) on fingolimod and 133 patients on another DMT were enrolled in 8 countries. For the fingolimod cohort, mean duration of MS was 12.3 years. Mean of 1.0 relapse in the year prior to study entry. Mean baseline EDSS score was 3.2. SAEs were reported in 4.1% and bradycardia in 2.3% of patients. Conclusions: PASSAGE is the first and only prospective, long-term, post-approval study of a large patient cohort that will provide longitudinal data on clinical outcomes, concurrently obtained, for all approved medications used to treat relapsing MS. Results will provide important insights on the use of fingolimod in real-world clinical practice.