P033 - PANGAEA: Post-authorization Noninterventional German Safety Study of GilEnyA in relapsing-remitting multiple sclerosis (RRMS) patients: A 24-month interim analysis of a German five-year fingolimod registry study

Abstract

Background/objective Fingolimod is a first-in-class, oral sphingosine-1-phosphate receptor modulator approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). PANGAEA investigates the safety, efficacy and pharmacoeconomic data from patients treated with fingolimod over five years. Here, we present 24-month interim data on disease progression and therapeutic compliance from fingolimod patients, formerly treatment-naïve, on baseline therapy (IFN-β and/or glatiramer acetate [GA]) or on natalizumab. Design/methods In addition to long-term safety and efficacy data, pharmacoeconomic aspects of fingolimod in routine clinical practice were assessed using questionnaires covering quality of life, treatment satisfaction, treatment compliance and consumption of resources. Results At the end of 2013, more than 4100 patients were enrolled in PANGAEA. An analysis at month 18 (n=406) revealed an improvement in EDSS in 16.0% of patients (sustained for at least 6 months). 73.7% had a stable EDSS and 10.3% of patients experienced a sustained EDSS progression. All patients showed a significant reduction in ARR, independent of former disease-modifying therapy (baseline ARR/ARR at month 12:all patients 1.5/0.4; former IFN-patients 1.6/0.4; former GA-patients: 1.6/0.4; former natalizumab patients: 1.1/0.4). Within the first 12 months of fingolimod treatment (n=2239), 3.8% of patients discontinued the study due to adverse events (11.5% total discontinuation). The ARR of former natalizumab patients, in the first year of fingolimod treatment (n=295), correlates with duration of natalizumab washout (?60 to ?120 days: ARR=0.88; >120 days: ARR=1.19). Conclusion The results of the 24-month interim-analysis of PANGAEA confirm the positive benefit-to-risk profile of fingolimod shown in phase III clinical trials, under real-world conditions. Fingolimod is a first-in-class, oral sphingosine-1-phosphate receptor modulator approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). PANGAEA investigates the safety, efficacy and pharmacoeconomic data from patients treated with fingolimod over five years. Here, we present 24-month interim data on disease progression and therapeutic compliance from fingolimod patients, formerly treatment-naïve, on baseline therapy (IFN-β and/or glatiramer acetate [GA]) or on natalizumab. In addition to long-term safety and efficacy data, pharmacoeconomic aspects of fingolimod in routine clinical practice were assessed using questionnaires covering quality of life, treatment satisfaction, treatment compliance and consumption of resources. At the end of 2013, more than 4100 patients were enrolled in PANGAEA. An analysis at month 18 (n=406) revealed an improvement in EDSS in 16.0% of patients (sustained for at least 6 months). 73.7% had a stable EDSS and 10.3% of patients experienced a sustained EDSS progression. All patients showed a significant reduction in ARR, independent of former disease-modifying therapy (baseline ARR/ARR at month 12:all patients 1.5/0.4; former IFN-patients 1.6/0.4; former GA-patients: 1.6/0.4; former natalizumab patients: 1.1/0.4). Within the first 12 months of fingolimod treatment (n=2239), 3.8% of patients discontinued the study due to adverse events (11.5% total discontinuation). The ARR of former natalizumab patients, in the first year of fingolimod treatment (n=295), correlates with duration of natalizumab washout (?60 to ?120 days: ARR=0.88; >120 days: ARR=1.19). The results of the 24-month interim-analysis of PANGAEA confirm the positive benefit-to-risk profile of fingolimod shown in phase III clinical trials, under real-world conditions.