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Interim data from the Hungarian Fingolimod Registry (CFTY720DHU01)
Author(s): ,
K. Bencsik
Affiliations:
Department of Neurology, University of Szeged, Szeged
,
T. Biernacki
Affiliations:
Department of Neurology, University of Szeged, Szeged
,
J. Füvesi
Affiliations:
Department of Neurology, University of Szeged, Szeged
,
C. Rózsa
Affiliations:
Department of Neurology, Jahn Ferenc Teaching Hospital, Budapest
,
S. Komoly
Affiliations:
Department of Neurology, University of Pécs, Pécs
,
P. Ács
Affiliations:
Department of Neurology, University of Pécs, Pécs
,
E. Dobos
Affiliations:
Department of Neurology, Szent Imre Hospital, Budapest
,
B. Cseh
Affiliations:
Department of Neurology, Borsod-Abaúj-Zemplén County and Teaching Hospital, Miskolc
,
J. Nikl
Affiliations:
Department of Neurology, Zala County Teaching Hospital, Zalaegerszeg
,
S. Péntek
Affiliations:
Department of Neurology, Zala County Teaching Hospital, Zalaegerszeg
,
G. Rum
Affiliations:
Department of Neurology, Petz Aladár County Teaching Hospital, Győ
,
A. Csányi
Affiliations:
Department of Neurology, Petz Aladár County Teaching Hospital, Győ
,
Á. Köves
Affiliations:
Department of Neurology, Bajcsy-Zsilinszky Street Hospital
,
K. Kovács
Affiliations:
Department of Neurology, Péterfy Sándor Street Hospital
,
G. Jakab
Affiliations:
Department of Neurology, Uzsoki Street Hospital
,
M. Simó
Affiliations:
Department of Neurology, Semmelweis University, Budapest
,
T. Csépány
Affiliations:
Department of Neurology, University of Debrecen, Debrecen
,
K. Bihari
Affiliations:
Department of Neurology, Bács-Kiskun County and Teaching Hospital, Kecskemét
,
Z. Jobbágy
Affiliations:
Department of Neurology, Bács-Kiskun County and Teaching Hospital, Kecskemét
,
A. Szentesi
Affiliations:
Medical Department, Novartis Hungary Ltd, Budapest
L. Vécsei
Affiliations:
Department of Neurology, University of Szeged, Szeged; MTA-SZTE Neuroscience Research Group, Szeged, Hungary
ECTRIMS Online Library. Bencsik K. Oct 12, 2018; 228158; P1780
Krisztina Bencsik
Krisztina Bencsik
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Abstract: P1780

Type: Poster Sessions

Abstract Category: N/A

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 2017.
Results: 535 patients were entered in the registry until 31 October 2017; 70% of patients were female. The mean disease duration of total patients is 10.31±6.634 years. 491 (91.8%) patients were treated with previous immunomodulatory therapy. 404 (75.51 %), 280 (52.33 %) and 171 (31.96 %) patients had received fingolimod for at least 1, 2 or 3 years, respectively. The annual relapse rate (ARR) of patients treated with fingolimod was substantially reduced from 0.84±0.69 (baseline) to 0.19±0.55 (p< 0.001) during the first-, to 0.36±0.69 (p< 0.001) during the 2nd and to 0.12±0.384 (p< 0.001) by the end of the 3rd year of treatment. The mean Expanded Disability Status Scale (EDSS) score was 2.80±1.55 at baseline. The EDSS score did not change substantially over time, by the end of the first year the mean score was 2.80±1.68 (p=0.819), by the end of the second year it was 2.92±1.76 (p=0.156).
Conclusions: The results of the 3rd year interim analysis of Hungarian fingolimod registry supports the positive effectiveness profile of fingolimod demonstrated in phase III clinical trials with real world evidence data.
Disclosure: Dr. Krisztina Bencsik: This study was sponsored by Novartis Hungary Ltd.
Dr. Tamás Biernacki: This study was sponsored by Novartis Hungary Ltd.
Dr. Judit Füvesi: This study was sponsored by Novartis Hungary Ltd.
Dr. Csilla Rózsa: This study was sponsored by Novartis Hungary Ltd.
Dr. Sámuel Komoly: This study was sponsored by Novartis Hungary Ltd.
Dr. Péter Ács: This study was sponsored by Novartis Hungary Ltd.
Dr. Enikő Dobos: This study was sponsored by Novartis Hungary Ltd.
Dr. Botond Cseh: This study was sponsored by Novartis Hungary Ltd.
Dr. János Nikl: This study was sponsored by Novartis Hungary Ltd.
Dr. Szilvia Péntek: This study was sponsored by Novartis Hungary Ltd.
Dr. Gábor Rum: This study was sponsored by Novartis Hungary Ltd.
Dr. Attila Csányi: This study was sponsored by Novartis Hungary Ltd.
Dr. Ágnes Köves: This study was sponsored by Novartis Hungary Ltd.
Dr. Krisztina Kovács: This study was sponsored by Novartis Hungary Ltd.
Dr. Gábor Jakab: This study was sponsored by Novartis Hungary Ltd.
Dr. Magdolna Simó: This study was sponsored by Novartis Hungary Ltd.
Dr. Tünde Csépány: This study was sponsored by Novartis Hungary Ltd.
Dr. Katalin Bihari: This study was sponsored by Novartis Hungary Ltd.
Dr. Zita Jobbágy: This study was sponsored by Novartis Hungary Ltd.
Annamária Szentesi: This study was sponsored by Novartis Hungary Ltd.
Prof. Dr. László Vécsei: This study was sponsored by Novartis Hungary Ltd.

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