Effectiveness of Fingolimod Compared with Interferons and Glatiramer Acetate for the Treatment of Multiple Sclerosis: A Matched Comparison of Treatments from the PANGAEA and PEARL Studies (P3.253)

OBJECTIVE: To compare clinical outcomes in matched cohorts of patients receiving fingolimod or BRACE (interferons or glatiramer acetate) following previous BRACE treatment, who had active MS (蠅1 relapse in the year before the study), using follow-up data from two German observational studies, PANGAEA and PEARL, respectively. BACKGROUND: PANGAEA is a 5-year study investigating the safety and effectiveness of fingolimod in daily practice. PEARL is a completed 2-year study that collected analogous data for BRACE. DESIGN/METHODS: Patients with active MS from the PANGAEA and PEARL registries were included if they had received BRACE before participating in the studies and did not have missing relapse data in the previous year. Patients in the PANGAEA cohort were excluded if they had participated in PEARL. Patients who met the inclusion/exclusion criteria were propensity-score matched (3:1) according to baseline and clinical characteristics using a greedy, nearest neighbor method according to the probability of receiving fingolimod (versus BRACE). Annualized relapse rates (ARRs) and 3-month and 6-month confirmed disability progression (CDP) were compared between cohorts. RESULTS: This analysis included 2842 patients (PANGAEA, n=2255; PEARL, n=587); 1716 were retained after propensity-score matching. There were no clinically important differences in baseline characteristics between the propensity-score-matched cohorts. ARRs were significantly lower in the PANGAEA cohort versus the matched PEARL cohort (48[percnt] reduction; ARR ratio: 0.52; 95[percnt] CI: 0.43-0.61; p<0.001). The risk of CDP was significantly reduced in patients in PANGAEA compared with those in PEARL (3-month: 37[percnt] reduced risk; HR, 0.63; 95[percnt] CI, 0.48-0.83; 6-month: 47[percnt] reduced risk; HR, 0.53; 95[percnt] CI, 0.39-0.74; p<0.001 for both). CONCLUSIONS: These results demonstrate that in clinical practice in patients with active MS, fingolimod is more effective than BRACE in reducing relapses and delaying CDP. Study Supported by: Analyses were supported by Novartis Pharma AG, Basel, Switzerland. Disclosure: Dr. Duerr has received personal compensation for activities with Numerus Ltd as an employee. Dr. Duerr9s employer has received research support from Novartis. Dr. Alsop has received personal compensation for activities with Numerus Ltd. as an employee. Dr. Alsop9s employer has received research support from Novartis. Dr. Bergvall has received personal compensation for activities with Novartis as an employee. Dr. Cornelissen has received personal compensation for activities with Novartis as an employee. I am a paid employee of Novartis Pharma GmbH, Dr. Ziemssen has nothing to disclose.