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Efficacy of glatiramer acetate in neuromyelitis optica spectrum disorder: a multicenter retrospective study

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Abstract

Glatiramer acetate (GA) is an approved therapy for relapsing–remitting multiple sclerosis, but its efficacy for the prevention of attacks in neuromyelitis optica spectrum disorder (NMOSD) remains unknown. We did a multicenter retrospective analysis of GA-treated patients with NMOSD, identified through a national registry. Annualized relapse rate and expanded disability status scale (EDSS) were the main outcome measures. We identified 23 GA-treated patients (21 female, 16 aquaporin-4 antibody-positive). GA was given for <6 months in seven patients; reasons for stopping were relapses (n = 3), confirmation of NMOSD (n = 2) and side effects (n = 2). Of 16 patients treated ≥6 months with GA (15 female, 11 aquaporin-4 antibody-positive), 14 experienced at least one relapse. There was no reduction in the mean annualized relapse rate in the total group (1.9 ± 1.1 before vs. 1.8 ± 1.4 during GA therapy), as well as in those patients who were aquaporin-4 antibody-positive, or had a history of prior immunotherapy or not. The median EDSS increased (2.5 start vs. 3.5 finish of GA, P < 0.05). GA therapy was discontinued in 15/16 patients; reasons were therapeutic inefficacy in 13 and post-injection skin reactions in two patients. We conclude that GA is not beneficial for preventing attacks in most patients with NMOSD, particularly in aquaporin-4 antibody-positive cases.

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Acknowledgments

There was no specific funding for this study.

Members of the Neuromyelitis Optica Study Group (NEMOS) in alphabetical order. All institutions are in Germany, unless otherwise indicated

P. Albrecht, University of Düsseldorf; O. Aktas, University of Düsseldorf; K. Angstwurm, University of Regensburg; I. Ayzenberg, Ruhr-University Bochum; A. Berthele, Technical University Munich; F. Bischof, University of Tübingen; N. Borisow, Charité University Medicine Berlin; T. Böttcher, Bonhoeffer Klinikum Neubrandenburg; J. Brettschneider, Klinikum Herford; M. Buttmann, University of Würzburg; B. Ettrich, University of Leipzig; J. Faiss, Asklepios Klinik Teupitz; A. Gass, University Hospital Mannheim; C. Geis, University of Jena; K. Guthke, Klinikum Görlitz; J. Havla, Ludwig Maximilians University Munich; H-P. Hartung, University of Düsseldorf; K. Hellwig, Ruhr-University Bochum; B. Hemmer, Technical University Munich; F. Hoffmann, Krankenhaus Martha-Maria Halle; U. Hofstadt-van Oy, Klinikum Westfalen Dortmund; S. Jarius, University of Heidelberg; M. Kaste, Nordwest-Krankenhaus Sanderbusch; P. Kermer, Nordwest-Krankenhaus Sanderbusch; P. Kern, Asklepios Klinik Teupitz; C. Kleinschnitz, University of Würzburg; I. Kleiter, Ruhr-University Bochum; W. Köhler, Fachkrankenhaus Hubertusburg; E. Kolesilova, Asklepios Klinik Teupitz; M. Krumbholz, Ludwig Maximilians University Munich; T. Kümpfel, Ludwig Maximilians University Munich; S. Langel, Landeskrankenhaus Rheinhessen; F. Lauda, University of Ulm; M. Liebetrau, Evangelische Bathildiskrankenhaus Bad Pyrmont gGmbH; R. Linker, University of Erlangen; W. Marouf, Heliosklinik Stralsund; M. Marziniak, Isar-Amper Klinik Ost Munich; A. Melms, University of Erlangen; I. Metz, University of Göttingen; C. Mayer, University of Frankfurt; C. Münch, Charité University Medicine Berlin; O. Neuhaus, SRH Krankenhaus Sigmaringen; S. Niehaus, Klinikum Dortmund; F. Pache, Charité University Medicine Berlin; F. Paul, Charité University Medicine Berlin, H. Pellkofer, University of Göttingen; A. Riedlinger, Asklepios Klinik Teupitz; M. Ringelstein, University of Düsseldorf; L. Röpke, University of Jena; S.P. Rommer, University of Vienna (Austria); K. Ruprecht, Charité University Medicine Berlin; C. Ruschil, University of Tübingen; S. Schippling, University of Zürich (Switzerland); S. Schuster, University of Hamburg; M. Schwab, University of Jena; M. Stangel, Hannover Medical School, J. Stellmann, University of Hamburg; M. Stoppe, University of Leipzig; F. Then-Bergh, University of Leipzig; C. Trebst, Hannover Medical School; J. Tünnerhoff, University of Tübingen; H. Tumani, University of Ulm; C. Veauthier, Charité University Medicine Berlin; A. Walter, Klinikum Herford; KP. Wandinger, University of Schleswig–Holstein; M. Weber, University of Göttingen; R. Weissert, University of Regensburg; B. Wildemann, University of Heidelberg; C. Wilke, Nervenzentrum Potsdam; A. Winkelmann, University of Rostock; K. Young, University of Hamburg; L. Zeltner, University of Tübingen; C. Zentner, Martha Maria, University of Halle; U. Zettl, University of Rostock; U. Ziemann, University of Tübingen.

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Authors and Affiliations

  1. Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Gudrunstr. 56, 44791, Bochum, Germany

    Ilya Ayzenberg, Joanna Schöllhammer, Robert Hoepner, Kerstin Hellwig & Ingo Kleiter

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

    Marius Ringelstein & Orhan Aktas

  3. Institute of Clinical Neuroimmunology, Faculty of Medicine, Ludwig Maximilians University, Munich, Germany

    Tania Kümpfel & Markus Krumbholz

  4. Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany

    Markus Krumbholz

  5. Department of Neurology, Hannover Medical School, Hannover, Germany

    Corinna Trebst

  6. Neurocure Clinical Research Center and Clinical and Experimental Multiple Sclerosis Research Center, Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany

    Friedemann Paul & Florence Pache

  7. Department of Neurology, University of Essen, Essen, Germany

    Mark Obermann

  8. Department of Neurology and Stroke, University of Tübingen, Tübingen, Germany

    Lena Zeltner

  9. Department of Neurology, Jena University Hospital, Jena, Germany

    Matthias Schwab

  10. Department of Neurology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany

    Achim Berthele

  11. Molecular Neuroimmunology Group, Department of Neurology, University of Heidelberg, Heidelberg, Germany

    Sven Jarius

  12. Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Berlin, Germany

    Friedemann Paul

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  1. Ilya Ayzenberg
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Neuromyelitis Optica Study Group (NEMOS)

Corresponding author

Correspondence to Ingo Kleiter.

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Conflicts of interest

Ilya Ayzenberg has received travel grants from the International Headache Society. Joanna Schöllhammer has no conflicts of interest. Robert Hoepner has no conflicts of interest. Kerstin Hellwig has received grants from the German Research Foundation. She received honoraria for speaking and research grants from Biogen Idec, Bayer, Teva, Merck, Novartis, and Genzyme. Marius Ringelstein has received speaker honoraria from Novartis and travel reimbursement from Bayer Schering, Biogen Idec and Genzyme. Orhan Aktas has received honoraria for speaking/consultation and travel grants from Bayer Healthcare, Biogen Idec, Chugai, Novartis, Merck Serono, and Teva and research grants from Bayer Healthcare, Biogen Idec, Novartis, and Teva as well as from the German Science Foundation (DFG) and the Federal Ministry of Education and Research (BMBF, EDEN/EU-FP7). None of this interfered with the current report. Markus Krumbholz has received grant support, traveling expenses and scientific advisory board honoraria from Novartis, the Novartis foundation and Genzyme. Tania Kümpfel has received travel expenses and speaking honoraria from Bayer Healthcare, Genzyme, Teva Pharma, Merck-Serono, Novartis, Sanofi-Aventis, and Biogen-Idec as well as grant support from Bayer-Schering AG and Novartis. Corinna Trebst has received honoraria for speaking, consultation and expert testimony and participation in advisory boards from Bayer Vital GmbH, Biogen Idec, Genzyme GmbH, Novartis Pharmaceuticals and Sanofi Aventis Deutschland GmbH. None of this interfered with the current report. Friedemann Paul has received honoraria for speaking/consultation and travel grants from Bayer Healthcare, Biogen Idec, Novartis, MedImmune, Merck Serono, Genzyme, and Teva, and research grants from the German Research Foundation, the German Ministry of Education and Research (BMBF/KKNMS, Competence Network Multiple Sclerosis), and the Guthy Jackson Charitable Foundation. Florence Pache was supported by the German Ministry of Education and Research (BMBF/KKNMS, Competence Network Multiple Sclerosis) and has received funding from a research grant from Novartis Pharmaceuticals and travel grants from the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and Genzyme, a Sanofi Company. None of this interfered with the current report. Mark Obermann was supported by the German Ministry of Education and Research (BMBF/KKNMS, Competence Network Multiple Sclerosis) and has received funding from a research grant from Novartis Pharmaceuticals and travel grants from the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and Genzyme, a Sanofi Company. None of this interfered with the current report. Lena Zeltner has no conflicts of interest. Matthias Schwab has no conflicts of interest. Achim Berthele has received a research grant on NMO from Bayer Healthcare and participates in a clinical phase III study on NMO sponsored by Alexion Pharmaceuticals. He has received honoraria for speaking/consultation and travel grants from Bayer Healthcare, Biogen Idec, Merck Serono, Genzyme, Novartis, and Teva. Ingo Kleiter has received honoraria for speaking/consultation and/or travel grants from Bayer Healthcare, Biogen Idec, Chugai, Merck Serono, and the Guthy Jackson Charitable Foundation, and research grants from Bayer Healthcare, Biogen Idec, and Novartis Pharmaceuticals, as well as from the MERCUR Foundation.

Ethical Standards

This study has been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. Ethics approval was obtained from the institutional review board of the Ruhr University Bochum (#4573-13) and by the institutional review boards of the participating academic centers.

Additional information

The members of the Neuromyelitis Optica Study Group (NEMOS) are given in acknowledgments.

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Ayzenberg, I., Schöllhammer, J., Hoepner, R. et al. Efficacy of glatiramer acetate in neuromyelitis optica spectrum disorder: a multicenter retrospective study. J Neurol 263, 575–582 (2016). https://doi.org/10.1007/s00415-015-7991-1

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