36 MONTHS PANGAEA- A 5-YEAR NON-INTERVENTIONAL STUDY OF SAFETY, EFFICACY AND PHARMACOECONOMIC DATA FOR FINGOLIMOD PATIENTS IN DAILY CLINICAL PRACTICE
Author(s)
Ziemssen T1, Albrecht H2, Haas J3, Klotz L4, Lang M5, Lassek C6, Schmidt S7, Tackenberg B8, Cornelissen C9
1University Clinic Carl Gustav Carus, Dresden, Germany, 2Praxis für Neurologie München, Munich, Germany, 3Jüdisches Krankenhaus Berlin, Berlin, Germany, 4Uniklinik Münster, Münster, Germany, 5NTD study group, Ulm, Germany, 6Neurologische Gemeinschaftspraxis Kassel und Vellmar, Kassel, Germany, 7NTD study group, Bonn, Germany, 8Philipps-Universität Giessen und Marburg, Marburg, Germany, 9Novartis Pharma GmbH, Nuremberg, Germany
OBJECTIVES: Once daily oral fingolimod (FTY720; Gilenya®, Novartis Pharma AG), is approved for the treatment of relapsing remitting multiple sclerosis(RRMS) in over 80 countries. As of February 2015, it is estimated that Gilenya® has been used to treat approximately 119,000 patients. The total patient exposure is approximately 218,500 patient years. PANGAEA (Post-Authorization Non-interventional German sAfety study of GilEnyA in RRMS patients) is a non-interventional study, conducted in Germany, to investigate long-term safety, tolerability and effectiveness of fingolimod in daily clinical practice. Here we present data of the 36 months interim-analysis. METHODS: Recruitment into PANGAEA finished in December 2013. 4229 patients were enrolled. In this interim-analysis we present data from patients that are treated with fingolimod for up to 36 months. RESULTS: The proportion of female patients was 71.6% and the mean age was 39.4 ±10.0 years. The annualized relapse rate of all PANGAEA patients improved from 1.5 (baseline) to 0.43 (month 12), 0.41 (month 24) and 0.37 (month 36). Of all enrolled PANGAEA patients 67.9% in the first, 68.3% in the second and 70.1% in the third year were relapse free. The mean EDSS of all PANGAEA patients was stable over 36 months at 3.0. In year 3 of PANGAEA 70.5% of the patients had no clinical disease activity measured by relapses and sustained EDSS progression. 10.8% of the patients discontinued the Fingolimod therapy in the first year (9.1% second year), 4,3% (2.3% second year) because of adverse events. 45.4% of the patients experienced no adverse events. Patients treatment satisfaction measured by the TSQM (Treatment Satisfaction Questionnaire for Medication)-9 Score, improved by 3 points over 24 months. CONCLUSIONS: The results of the 36 months interim analysis of PANGAEA support the positive safety and effectiveness profile demonstrated in phase the III clinical trials. PANGAEA is a valuable source data for patients treated with fingolimod in daily clinical routine.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PND2
Topic
Clinical Outcomes, Epidemiology & Public Health
Topic Subcategory
Comparative Effectiveness or Efficacy, Safety & Pharmacoepidemiology
Disease
Neurological Disorders