Real World Evidence (RWE) on Long-Term Persistence of Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) in Australia

Abstract

Introduction This study aimed to examine and compare patient persistence of fingolimod to all reimbursed disease modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS) in Australia. Method The Pharmaceutical Benefits Scheme (PBS) 10% sample supplied by the Department of Human Services was used in this study. Eligible patients must have received a script for a reimbursed DMT for RRMS between September 2011 and February 2016. Patient demographics were summarised using mean and standard deviation or frequency percentage. Persistence was defined as a patient that remained on a DMT with a gap in scripts of no longer than 4 months. Individual patients could be included multiple times if they initiated a new DMT during the study period. Persistence was derived using the Kaplan-Meier method and hazard ratios (HR). Persistence to individual treatments was then compared to the average persistence observed across all treatments; p-values were based on the log-rank test. Results 720 unique patients were eligible for the study, contributing 1827 observations that for analysis (2.5 new initiations/patient). Overall the median persistence (MP) to therapy was 29.6 months with 67.7% of patients remaining on therapy for 12 months. The only DMT with significantly better persistence compared to the overall average was fingolimod (HR 0.65 (95%CI 0.57–0.73; p<0.001). Patients had an MP of 60 months on fingolimod with 79.5% of patients persistent at 12 months. Patients were significantly less persistent to interferon Beta-1a, interferon Beta-1b, glatiramer acetate and dimethyl fumarate (hazard ratios above 1.27 (p values all≤0.001) whilst the remaining DMTs, teriflunomide and natalizumab, showed no significant difference from the average persistence. Conclusion In this analysis of PBS sample data, patients were most persistent to fingolimod treatment amongst all DMTs.