Contributions
Abstract: EP1696
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Fingolimod is a sphingosine 1-phosphate receptor modulator approved by the European Medicines Agency (EMA) in 2011. Fingolimod has been reimbursed in Hungary since 2014 for second-line and for first-line treatment of patients (by reference to the summary of product characteristics ) with relapsing-remitting multiple sclerosis (RRMS) to reduce disease activity.
Objective: This non-interventional study aims to collect long term data on real-world effectiveness in patients treated with fingolimod in Hungary.
Design and methods: This study combines retrospective and prospective methods from fingolimod treated patients in order to obtain long term 5 year datasets from 21 multiple sclerosis centers. The interim analysis on the dataset was available on 31 October 2016.
Results: 475 patients were entered in the registry until 31 October 2016; 70% of patients were female. The mean disease duration of total patients is 10.56±6.69 years. 92.10% patients were treated with previous immunomodulatory therapy. 276 (58.10 %) and 177 (37.26 %) patients had received fingolimod for at least 1 or 2 years, respectively. The annual relapse rate (ARR) of patients treated with fingolimod was substantially reduced from 0.90±0.75 (baseline) to 0.21±0.55 (p< 0.001) during the first year of treatment and to 0.36±0.69 (p< 0.001) by the end of the second year. The mean baseline Expanded Disability Status Scale (EDSS) score was 2.82±1.58 at baseline. The EDSS score did not change substantially over time, by the end of the first year the mean score was 2.84±1.68 (p=0.423), by the end of the second year it was 2.97±1.80 (p=0.423).
Conclusions: The results of the 2 year interim analysis of Hungarian fingolimod registry support the positive effectiveness profile of fingolimod demonstrated in phase III clinical trials with real world evidence data.
Disclosure:
K. Bencsik: This study was sponsored by Novartis Hungary Ltd.
T. Biernacki: This study was sponsored by Novartis Hungary Ltd.
J. Füvesi: This study was sponsored by Novartis Hungary Ltd.
Cs. Rózsa: This study was sponsored by Novartis Hungary Ltd.
S. Komoly: This study was sponsored by Novartis Hungary Ltd.
L. Bors: This study was sponsored by Novartis Hungary Ltd.
P. Ács: This study was sponsored by Novartis Hungary Ltd.
A. Trauninger: This study was sponsored by Novartis Hungary Ltd.
E. Dobos: This study was sponsored by Novartis Hungary Ltd.
B. Cseh: This study was sponsored by Novartis Hungary Ltd.
J. Nikl: This study was sponsored by Novartis Hungary Ltd.
Sz. Péntek: This study was sponsored by Novartis Hungary Ltd.
J. Kasza: This study was sponsored by Novartis Hungary Ltd.
G. Rum: This study was sponsored by Novartis Hungary Ltd.
L. Jávor: This study was sponsored by Novartis Hungary Ltd.
A. Csányi: This study was sponsored by Novartis Hungary Ltd.
G. Tóth: This study was sponsored by Novartis Hungary Ltd.
A. Mike: This study was sponsored by Novartis Hungary Ltd.
Á. Köves: This study was sponsored by Novartis Hungary Ltd.
Gy. Györök: This study was sponsored by Novartis Hungary Ltd.
Zs. Simon: This study was sponsored by Novartis Hungary Ltd.
K. Kovács: This study was sponsored by Novartis Hungary Ltd.
A. Rózsa: This study was sponsored by Novartis Hungary Ltd.
G. Jakab: This study was sponsored by Novartis Hungary Ltd.
Á.Gyulai: This study was sponsored by Novartis Hungary Ltd.
I. Mayer: This study was sponsored by Novartis Hungary Ltd.
B. Szabó: This study was sponsored by Novartis Hungary Ltd.
M. Simó: This study was sponsored by Novartis Hungary Ltd.
N. Tegze: This study was sponsored by Novartis Hungary Ltd.
A. Iljicsov: This study was sponsored by Novartis Hungary Ltd.
Z. Jobbágy: This study was sponsored by Novartis Hungary Ltd.
A. Szentesi: This study was sponsored by Novartis Hungary Ltd.
L. Vécsei : This study was sponsored by Novartis Hungary Ltd.
Abstract: EP1696
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Fingolimod is a sphingosine 1-phosphate receptor modulator approved by the European Medicines Agency (EMA) in 2011. Fingolimod has been reimbursed in Hungary since 2014 for second-line and for first-line treatment of patients (by reference to the summary of product characteristics ) with relapsing-remitting multiple sclerosis (RRMS) to reduce disease activity.
Objective: This non-interventional study aims to collect long term data on real-world effectiveness in patients treated with fingolimod in Hungary.
Design and methods: This study combines retrospective and prospective methods from fingolimod treated patients in order to obtain long term 5 year datasets from 21 multiple sclerosis centers. The interim analysis on the dataset was available on 31 October 2016.
Results: 475 patients were entered in the registry until 31 October 2016; 70% of patients were female. The mean disease duration of total patients is 10.56±6.69 years. 92.10% patients were treated with previous immunomodulatory therapy. 276 (58.10 %) and 177 (37.26 %) patients had received fingolimod for at least 1 or 2 years, respectively. The annual relapse rate (ARR) of patients treated with fingolimod was substantially reduced from 0.90±0.75 (baseline) to 0.21±0.55 (p< 0.001) during the first year of treatment and to 0.36±0.69 (p< 0.001) by the end of the second year. The mean baseline Expanded Disability Status Scale (EDSS) score was 2.82±1.58 at baseline. The EDSS score did not change substantially over time, by the end of the first year the mean score was 2.84±1.68 (p=0.423), by the end of the second year it was 2.97±1.80 (p=0.423).
Conclusions: The results of the 2 year interim analysis of Hungarian fingolimod registry support the positive effectiveness profile of fingolimod demonstrated in phase III clinical trials with real world evidence data.
Disclosure:
K. Bencsik: This study was sponsored by Novartis Hungary Ltd.
T. Biernacki: This study was sponsored by Novartis Hungary Ltd.
J. Füvesi: This study was sponsored by Novartis Hungary Ltd.
Cs. Rózsa: This study was sponsored by Novartis Hungary Ltd.
S. Komoly: This study was sponsored by Novartis Hungary Ltd.
L. Bors: This study was sponsored by Novartis Hungary Ltd.
P. Ács: This study was sponsored by Novartis Hungary Ltd.
A. Trauninger: This study was sponsored by Novartis Hungary Ltd.
E. Dobos: This study was sponsored by Novartis Hungary Ltd.
B. Cseh: This study was sponsored by Novartis Hungary Ltd.
J. Nikl: This study was sponsored by Novartis Hungary Ltd.
Sz. Péntek: This study was sponsored by Novartis Hungary Ltd.
J. Kasza: This study was sponsored by Novartis Hungary Ltd.
G. Rum: This study was sponsored by Novartis Hungary Ltd.
L. Jávor: This study was sponsored by Novartis Hungary Ltd.
A. Csányi: This study was sponsored by Novartis Hungary Ltd.
G. Tóth: This study was sponsored by Novartis Hungary Ltd.
A. Mike: This study was sponsored by Novartis Hungary Ltd.
Á. Köves: This study was sponsored by Novartis Hungary Ltd.
Gy. Györök: This study was sponsored by Novartis Hungary Ltd.
Zs. Simon: This study was sponsored by Novartis Hungary Ltd.
K. Kovács: This study was sponsored by Novartis Hungary Ltd.
A. Rózsa: This study was sponsored by Novartis Hungary Ltd.
G. Jakab: This study was sponsored by Novartis Hungary Ltd.
Á.Gyulai: This study was sponsored by Novartis Hungary Ltd.
I. Mayer: This study was sponsored by Novartis Hungary Ltd.
B. Szabó: This study was sponsored by Novartis Hungary Ltd.
M. Simó: This study was sponsored by Novartis Hungary Ltd.
N. Tegze: This study was sponsored by Novartis Hungary Ltd.
A. Iljicsov: This study was sponsored by Novartis Hungary Ltd.
Z. Jobbágy: This study was sponsored by Novartis Hungary Ltd.
A. Szentesi: This study was sponsored by Novartis Hungary Ltd.
L. Vécsei : This study was sponsored by Novartis Hungary Ltd.