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• W3204374402 abstract "Objective: PANGAEA (Post-Authorization Non-interventional GermansAfety of GilEnyA in RRMS patients) is a non-interventional study (NIS), conducted in Germany, to investigate long-term safety, effectiveness and patient reported outcomes in daily clinical practice. Background: Once-daily fingolimod (Gilenya®, Novartis Pharma AG) is a sphingosine 1-phosphate receptor modulator approved for the treatment of relapsing MS. As of July 2015 more than 160.000 patients have been treated with fingolimod; total patient exposure exceeds 368.000 patient-years. Design/Methods: Recruitment into the study finished in December 2013. 4229 patients from 374 centers were enrolled. By Jan 2017 over 300 patients finished the 5 year documentation period of fingolimod treatment. In this Interim analysis we present effectiveness data of fingolimod in daily clinical practice. Results: The proportion of female patients was 71.6 % and the mean age was 39.4 (± 10.0 SD) years. The mean annual relapse rate of PANGAEA patients improved from 1.5 ± 0.13 (95%CI; baseline) to 0.42 ± 0.08 and remained stable over a period of 5 years. The mean baseline EDSS in PANGAEA was 3.0 (±0.03; 95%CI)) and remained stable over 5 years. In each year of treatment more than 90% of the patients had a stable EDSS or experienced a 6 months confirmed improvement. In each year of treatment over 70% of the patients were free of relapses and 6 months confirmed disability progression. 45% of the patients neither had a relapse nor a 6 months confirmed disability progression over 4 years of treatment. Patient reported outcomes (EQ-5D, TSQM-9) evaluated in a substudy (n=830) over a period of 24 months confirmed the good effectiveness and convenience profile of fingolimod from a patient point of view. Conclusions: The results of the 5 year interim analysis of PANGAEA support the positive effectiveness profile of fingolimod demonstrated in phase III clinical trials with real world evidence data. Study Supported by: Novartis Pharma GmbH, Nuremberg, Germany Disclosure: Dr. Ziemssen has received personal compensation for activities with Dr. Albrecht has received personal compensation for activities with Sanofi Genzyme, Novartis, and Biogen. Dr. Haas has received personal compensation for activities with Bayer Schering, Teva Aventis, Merck Serono, Biogen Idec, Allergan, Inc., and Octapharma as a consultant. Dr. Klotz has received personal compensation for activities with Genzyme, Novartis, CSL Behring, and Merck Serono as an advisory board member and a speaker. Dr. Lang has received personal compensation for activities with Novartis, Biogen Idec, Bayer, Teva, Serono and Genzyme. Dr. Lassek has received personal compensation for activities with Teva, Merck Serono, Genzyme -Sanofi, Novartis, Bayer, and Biogen. Dr. Schmidt received personal compensation for activities with Bayer Vital, Biogen Idec, MerckSerono, Teva, Sanofi, and Novartis as a scientific advisory board member and a speaker. Dr. Tackenberg has received personal compensation for activities with Bayer Healthcare, Biogen Idec, Merck Serono, Novartis Pharma, and Teva Pharma as a speaker and consultant. Dr. Cornellissen has received personal compensation for activities with Novartis Pharma GmbH as an employee." @default.
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• W3204374402 date "2017-04-18" @default.
• W3204374402 modified "2023-09-24" @default.
• W3204374402 title "5 years effectiveness of fingolimod in daily clinical practice: results of the non-interventional study PANGAEA documenting RRMS patients treated with fingolimod in Germany (P6.345)" @default.
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