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May 2019; 6 (3) ArticleOpen Access

Real-world persistence and benefit–risk profile of fingolimod over 36 months in Germany

Tjalf Ziemssen, Michael Lang, Björn Tackenberg, Stephan Schmidt, Holger Albrecht, Luisa Klotz, Judith Haas, Christoph Lassek, C. Anne-Marie Couto, John A. Findlay, Christian Cornelissen, on behalf of the PANGAEA study group
First published March 7, 2019, DOI: https://doi.org/10.1212/NXI.0000000000000548
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Article Information

vol. 6 no. 3 e548
DOI: 
https://doi.org/10.1212/NXI.0000000000000548
PubMed: 
30882022
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Online ISSN: 
2332-7812
History: 
  • Received July 27, 2018
  • Accepted in final form January 8, 2019
  • First Published March 7, 2019.
Copyright & Usage: 
Copyright © 2019 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Author Disclosures

    1. Tjalf Ziemssen, MD, PhD,
    2. Michael Lang, MD,
    3. Björn Tackenberg, MD,
    4. Stephan Schmidt, MD,
    5. Holger Albrecht, MD,
    6. Luisa Klotz, MD,
    7. Judith Haas, MD,
    8. Christoph Lassek, MD,
    9. C. Anne-Marie Couto, DPhil,
    10. John A. Findlay, PhD,
    11. Christian Cornelissen, PhD;
    12. on behalf of the PANGAEA study group
  1. Tjalf Ziemssen, MD, PhD,
    2. Scientific Advisory Boards:

    1. (1) Bayer Healthcare (2) Biogen Idec (3) Novartis (4) Merck Serono (5) Teva (6) Genzyme (7) Roche (8) Celgene; all commercial

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Speaker honorarium for all commercial entities (1) Bayer Healthcare (2) Biogen Idec (3) Sanofi Genzyme (4) Celgene (5) Roche (6) Novartis (7) Teva (8) Almirall (o) Merck

    Editorial Boards:

    1. (1) BMC Neurology, Section editor, demyelinating disorders, since 2016

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. (1) Biogen Idec (2) Sanofi Genzyme (3) Novartis (4) Teva

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. Expert witness for glatiramer acetate, 2015-2016

  2. Michael Lang, MD,
    3. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  3. Björn Tackenberg, MD,
    4. Scientific Advisory Boards:

    1. Served on scientific advisory boards for (1) Biogen-idec Germany and USA, (2) Bayer Healthcare Germany and USA, (3) Novartis Germany and Int(4) Merck-Serono Germany and Int, (5) Octapharma Germany, (6) CSL Behring Germany, (7) GRIFOLS Germany and Int, (8) Alexion Int, (9) Celgene Int, (10) Sanofi Genzyme Int

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. received speaker honoraria from (1) Biogen-idec Germany and USA, (2) Bayer Healthcare Germany and USA, (3) Novartis Germany and Int(4) Merck-Serono Germany and Int, (5) Octapharma Germany, (6) CSL Behring Germany, (7) GRIFOLS Germany and Int, (8) Alexion Int, (9) Celgene Int, (10) Sanofi Genzyme Int

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. received Consultancy fees from (1) Biogen-idec Germany and USA, (2) Bayer Healthcare Germany and USA, (3) Novartis Germany and Int(4) Merck-Serono Germany and Int, (5) Octapharma Germany, (6) CSL Behring Germany, (7) GRIFOLS Germany and Int, (8) Alexion Int, (9) Celgene Int, (10) Sanofi Genzyme Int

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. (1) Bayer Healthcare, (2) Biogen-idec Int, (3) Novartis Germany, (4) Sanofi-Aventis Germany

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. (1) Marburg University Trust

    Research Support, Foundations and Societies:

    1. F?rderverein Neurologie e. V. (FN) German Myasthenia gravis Society (DMG) German Society of Neurology (DGN)

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  4. Stephan Schmidt, MD,
    5. Scientific Advisory Boards:

    1. (1) Novartis; (2) Merck Serono; (3) Bayer Vital; (4) Biogen Idec; (5) Genzyme; (6) TEVA

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. (1) Novartis; (2) Merck Serono; (3) Bayer Vital; (4) Biogen Idec; (5) Genzyme; (6) TEVA

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Bayer Vital. Grant for a clinical study entitled: Aerobic endurance exercise in mildly disabled MS patients

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  5. Holger Albrecht, MD,
    6. Scientific Advisory Boards:

    1. (1)Merck Company (2)Biogen (3)Sanofi-Aventis (4)Novartis (5)Mylan

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. (1)Merck, travel refunding for congress and speaker honoraria (2)Novartis, travel refunding for congress (3)Biogen, travel refunding for congress (4)Celgene, travel refunding for congress

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  6. Luisa Klotz, MD,
    7. Scientific Advisory Boards:

    1. (1) Genzyme (2) Novartis (3) Biogen (4) Roche (5) Merck (6) CSL Behring

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. (1) Novartis, speaker honoraria and travel support (2) Merck Serono, speaker honoraria and travel support (3) Biogen, speaker honoraria and travel support (4) Roche, speaker honoraria and travel support (5) Genzyme, speaker honoraria and travel Support (6) CSL Behring, speaker honoraria and travel Support

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. (1) Novartis (2) Biogen

    Research Support, Government Entities:

    1. (1) (CRC) SFB TR-128 Impact of dietary factors on the gut-CNS-axis ? implications for CNS autoimmunity A08, Project leader, 2016-2020 (2) (CRC) SFB 1009 ?Immune-cell interactions with endothelial cells and pericytes at the blood-brain- barrier: mechanisms and consequences? A03, Sub-project Leader, 2012-2020 (3) CRC; ?The role of the nuclear receptor NR4A1 in acute ischemic stroke: pathophysiology, therapy evaluation and human translation';Sub-Project leader, 2018-2020 (4) Federal Ministry of Education and Research (BMBF) Competence Network Multiple Sklerose: ?Multi-parameter immune cell-profiling: identification of biosignatures to understand heterogeneity, prognosis and treatment response factors in MS?, 3.1 Sub-project Leader, 2016-2020

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  7. Judith Haas, MD,
    8. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Honorarium from Biogen Idec, Merck Serrono, Bayer-Schering Pharma, Teva- Aventis, Novartis, Octapharma

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  8. Christoph Lassek, MD,
    9. Scientific Advisory Boards:

    1. (1) Merck Serono 2017 and 2018 (2) Genzyme -Sanofi 2017 and 2018(3) Novartis 2017 and 2018 (4) Roche 2017 and 2018 (5) Biogen Idec 2017 and 2018

    Gifts:

    1. 1) Merck Serono 2017 and 2018 (2) Genzyme -Sanofi 2017 and 2018(3) Novartis 2017 and 2018 (4) Roche 2017 and 2018 (5) Biogen Idec 2017 and 2018

    Funding for travel or speaker honoraria:

    1. 1) Merck Serono 2017 and 2018 (2) Genzyme -Sanofi 2017 and 2018(3) Novartis 2017 and 2018 (4) Roche 2017 and 2018 (5) Biogen Idec 2017 and 2018

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. 1) Merck Serono 2017 and 2018 (2) Genzyme -Sanofi 2017 and 2018(3) Novartis 2017 and 2018 (4) Roche 2017 and 2018 (5) Biogen Idec 2017 and 2018

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  9. C. Anne-Marie Couto, DPhil,
    10. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Oxford PharmaGenesis, Principal Consultant, 5 years

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  10. John A. Findlay, PhD,
    11. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Oxford PharmaGenesis, Consultant, 1 year.

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  11. Christian Cornelissen, PhD;
    12. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Siemens Healthcare GmbH, Erlangen, Germany, Senior Project Manager, 2018 - current Novartis Pharma GmbH, Nuremberg, Germany, Medical Advisor, 2013-2018

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  12. on behalf of the PANGAEA study group
  1. From the Center of Clinical Neuroscience (T.Z.), Neurological University Clinic Carl Gustav Carus, University of Technology, Dresden; NeuroPoint Patient Academy and Neurological Practice (M.L.), Ulm; Department of Neurology (B.T.), Center of Neuroimmunology, Philipps-University, Marburg; Bonn Neurological Practice (S.S.); Neurological Practice (H.A.), Munich; Department of Neurology (L.K.), University Hospital Münster, Münster; Centre for Multiple Sclerosis (J.H.), Jewish Hospital Berlin; Kassel and Vellmar Neurology Practice (C.L.), Vellmar, Germany; Oxford PharmaGenesis (C.A-M.C.); Oxford PharmaGenesis (J.A.F.), United Kingdom; and Novartis Pharma GmbH (C.C.), Nuremberg, Germany.
  1. Correspondence
    Prof. Ziemssen Tjalf.Ziemssen{at}uniklinikum-dresden.de
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