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Switching from natalizumab to fingolimod treatment in multiple sclerosis: real life data from the Austrian MS Treatment Registry

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A Correction to this article was published on 17 September 2019

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Abstract

Objectives

To compare the efficacy of natalizumab (NTZ) and fingolimod (FTY) in the treatment of relapsing–remitting multiple sclerosis (MS) in sequential use in common and as a function of transition periods in a nationwide observational cohort using prospectively collected data from a real-life setting.

Materials and methods

We included 195 patients from the Austrian MS Treatment Registry, who had started treatment with NTZ at any time since 2006 and stayed on NTZ for at least 24 months, switched afterwards within 1 year to FTY and stayed on FTY for at least another 12 months. Transition periods between NTZ and FTY were grouped into three different intervals: < 3 months (135 patients), 3–6 months (44 patients), and 6–12 months (16 patients).

Results

Estimated mean annualized relapse rates (ARR) over a mean treatment period of 44 months were 0.26 for NTZ and 0.32 for FTY (p = 0.381) over 46 months. In the treatment gap, differences were found concerning the relapse probability, seven (5.2%) patients in the < 3 months group, six (13.6%) in thef 3–6 months group, and seven (43.8%) in the 6–12 months group (p < 0.001). After this treatment gap, no significant differences concerning ARR, EDSS change, EDSS progression, and regression were observed regardless the proceeding transition periods. Significantly higher efficacy of NTZ compared to FTY in sequential use was found regarding EDSS change, EDSS progression, and EDSS regression sustained for 12 and 24 weeks.

Conclusions

First, we here show an increased short-time risk for relapses during the treatment gap between NTZ and FTY therapy, dependent on the length of transition time. Second, the disease course after switching to FTY remained stable in the long-term evaluation. Therefore, switching from NTZ to FTY in a real-world setting appears efficacious and safe, but this data advocate for a short switching gap of 3 months or less.

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Change history

  • 17 September 2019

    The original version of this article unfortunately contained a mistake. First and last names of the authors were interchanged. The correct author names are given below.

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Acknowledgements

The Steering Group wishes to thank all Austrian MS centres (https://www.oegn.at/neurologie-in-oesterreich/ms-zentren/) for contributing data to the registry and to the patients for providing written informed consent.

Funding

The Austrian MS Treatment Registry is supported by unrestricted grants of Biogen Austria, Novartis Pharma Austria and Genzyme Austria.

Author information

Authors and Affiliations

  1. Clinic for Neurology 2, Med Campus III, Kepler University Clinic, Krankenhausstrasse 9, 4021, Linz, Austria

    Michael Guger

  2. Department of Neurology, Medical University of Graz, Graz, Austria

    Christian Enzinger

  3. Department of Neurology, Medical University of Vienna, Vienna, Austria

    Fritz Leutmezer & Thomas Berger

  4. Department of Laboratory Medicine, Paracelsus Medical University and Salzburger Landeskliniken, Salzburg, Austria

    Jörg Kraus

  5. Department of Neurology, Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany

    Jörg Kraus

  6. Hermesoft, Data management, Graz, Austria

    Stefan Kalcher

  7. Hermesoft, Statistics, Graz, Austria

    Erich Kvas

Authors
  1. Michael Guger
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  2. Christian Enzinger
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  3. Fritz Leutmezer
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  4. Jörg Kraus
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  5. Stefan Kalcher
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  6. Erich Kvas
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  7. Thomas Berger
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Consortia

on behalf of the Austrian MS Treatment Registry (AMSTR)

Corresponding author

Correspondence to Michael Guger.

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Conflicts of interest

Michael Guger received support and honoraria for research, consultation, lectures, and education from Almirall, Bayer, Biogen, Celgene, Genzyme, MedDay, Merck, Novartis, Octapharma, Roche, Sanofi Aventis, Shire, and TEVA ratiopharm. Christian Enzinger received funding for travel and speaker honoraria from Biogen, Bayer, Celgene, Merck, Novartis, Roche, Shire, Sanofi-Genzyme, and Teva Pharmaceutical Industries Ltd./sanofi-aventis, research support from Merck Serono, Biogen, Sanofi-Genzyme, and Teva Pharmaceutical Industries Ltd./sanofi-aventis and serving on scientific advisory boards for Bayer Schering, Biogen, Merck Serono, Novartis, Roche, and Teva Pharmaceutical Industries Ltd./sanofi-aventis. Fritz Leutmezer has received funding for travel and speaker honoraria from Biogen, Bayer Schering Pharma, Merck Serono, Novartis, Genzyme, Santhera, and Teva Pharmaceutical Industries Ltd./sanofi-aventis. Jörg Kraus received consulting and/or research funding and/or educational support from Almirall, Bayer, Biogen, Celgene, MedDay, Medtronic, Merck, Novartis, Roche, Sanofi-Aventis, Shire, TEVA ratiopharm. Stefan Kalcher declares that there is no conflict of interest. Erich Kvas declares that there is no conflict of interest. Thomas Berger has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for multiple sclerosis: Almirall, Bayer, Biogen, Biologix, Bionorica, Genzyme, MedDay, Merck, Novartis, Octapharma, Roche, Sanofi/Genzyme, TG Pharmaceuticals, TEVA-ratiopharm, and UCB. His institution has received financial support in the last 12 months by unrestricted research grants (Biogen, Bayer, Merck, Novartis, Sanofi/Genzyme, and TEVA ratiopharm) and for participation in clinical trials in multiple sclerosis sponsored by Alexion, Bayer, Biogen, Merck, Novartis, Octapharma, Roche, Sanofi/Genzyme, and TEVA.

Ethical standards

The AMSTR is compliant with Austrian laws on bioethics and it was also approved by the ethical committee of the Medical University of Vienna (EC number 2096/2013).

Additional information

The original version of this article was revised: First and last names of the authors were interchanged.

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Guger, M., Enzinger, C., Leutmezer, F. et al. Switching from natalizumab to fingolimod treatment in multiple sclerosis: real life data from the Austrian MS Treatment Registry. J Neurol 266, 2672–2677 (2019). https://doi.org/10.1007/s00415-019-09464-0

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  • DOI: https://doi.org/10.1007/s00415-019-09464-0

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