Real World Effectiveness of First-Line Use of Gilenya: A Two-Site Retrospective Study (P5.361)

Objective: To assess the baseline characteristics and clinical effectiveness, of Fingolimod (FTY) in DMT-naive patients versus those previously treated with IFN-1b or Glatiramer Acetate, in a relapsing MS population over 18 months. Background: This observational, retrospective study at two large academic MS centers (Cleveland Clinic and University of Colorado) was designed to examine differences between first line and second line fingolimod use. Design/Methods: All patients starting fingolimod were identified. Participant records were assigned to First-line (FL) (no prior DMT use) or second-line (SL) (use of single injectable DMT prior to fingolimod) cohorts. Clinical and demographic data were manually extracted into REDCap databases. Patients were followed for 18 months on FTY. Baseline was defined as the start date of the FTY in each cohort. De-identified data from each site were combined and analyzed in SAS. Results: A total of 168 records were eligible (66 FL cohort, 102 SL cohort). In the FL cohort there was a significant reduction in the proportion of patients with relapses (42.4% vs.10.6%), proportion of patients with gadolinium enhancing lesions (36.0% vs. 2.3%) and new T2 lesions (16.3%, 10.8%) when compared to baseline. Demographic characteristics between the cohorts were similar (age, gender, race). Disease duration prior to FTY start was longer in the SL cohort (4.0 years [SL] vs. 1.7 [FL] years). Clinical activity between the cohorts was not significantly different at 18 months for annualized relapse rate, time to first relapse, MRI measures, and no evidence of disease activity (MRI activity and relapses). Propensity adjusted outcomes will be presented. Conclusions: FTY use as a first-line agent decreases clinical activity in RRMS. Patients on FTY as a SL agent demonstrated a similar decrease in activity compared to those using FTY as a FL agent. The use of FTY as a first line agent is supported by retrospective, real-world data. Study Supported by: Novartis Pharmaceuticals Corporation Disclosure: Dr. Planchon has nothing to disclose. Dr. Vollmer has nothing to disclose. Dr. Kim has nothing to disclose. Dr. Sillau has nothing to disclose. Dr. Li has nothing to disclose. Dr. Rastogi has nothing to disclose. Dr. Dattanand has nothing to disclose. Dr. Vieira has received personal compensation for activities with Novartis. Dr. Nair has received personal compensation for activities with Astellas. Dr. Nair has received research support from Novartis, Biogen, Gilead Sciences, and Genentech. Dr. Ontaneda has received personal compensation for activities with Teva Neuroscience, Mallincrkodt, and Genzyme Corporation. Dr. Alvarez has received personal compensation from Teva Neuroscience, Biogen, Genzyme, Genentech, and Novartis. Dr. Alvarez has received research support from Biogen, Teva, and Novartis.