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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
Tjalf Ziemssen
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.
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Michael Lang
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.
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Björn Tackenberg
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.
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Stephan Schmidt
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.
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Holger Albrecht
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.
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Luisa Klotz
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.
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Judith Haas
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.
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Christoph Lassek
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.
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C. Anne-Marie Couto
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.
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John A. Findlay
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.
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Christian Cornelissen
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.
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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.
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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
Neurol Neuroimmunol Neuroinflamm May 2019, 6 (3) e548; DOI: 10.1212/NXI.0000000000000548

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    Figure 1 Relapsea outcomes during 36 months of fingolimod treatment

    (A) Mean ARR during the 12-month prebaseline period before fingolimod initiation and during each 12-month follow-up period and in the overall 36-month follow-up period following fingolimod initiation. (B) Proportion of patients with relapse(s) during the 12-month prebaseline period before fingolimod initiation and during each 12-month follow-up period and in the overall 36-month follow-up period following fingolimod initiation. aRelapses were assessed in accordance with the clinical judgment of physicians in the real world. Relapses were not included in this analysis if they occurred within 30 days of a previous relapse that had already been included. Error bars show 95% CI. ARR = annualized relapse rate; n = number of patients. Data relating to the ARR for the 12-month prebaseline and 0–12-month periods were taken from Ziemssen T, Lang M, Tackenberg B et al. Clinical and demographic profile of patients receiving fingolimod in clinical practice in Germany and the benefit–risk profile of fingolimod after 1 year of treatment: initial results from the observational, noninterventional study PANGAEA. Neurotherapeutics 2018;15:190–199, with the permission of the copyright holders (authors).

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    Figure 2 Disability outcomes during 36 months of fingolimod treatment

    (A) Mean change in the EDSS score during each 12-month follow-up period and in the overall 36-month follow-up period following fingolimod initiation. (B) Mean proportion of patients with 6-month confirmed disability improvement or 6-month confirmed disability worsening during each 12-month follow-up period and in the overall 36-month follow-up period following fingolimod initiation. aConfirmed disability improvement was assessed in accordance with the decreases in the EDSS score from baseline, with confirmation of the decrease in disability made at a visit in the absence of a relapse: a decrease of at least 1 point regardless of baseline EDSS scores. bConfirmed disability worsening was assessed in accordance with the increases in EDSS score from baseline, with confirmation of the increase in disability made at a visit in the absence of a relapse: a 1.5-point increase from a baseline EDSS score of 0; a 1-point increase from baseline EDSS scores of 1–5.0; and a 0.5-point increase in baseline EDSS scores of 5.5 or more. Patients for whom MS was a cause of death were considered to have confirmed disability worsening irrespective of baseline EDSS score or change in the EDSS score. Error bars show 95% CI. EDSS = Expanded Disability Status Scale; n = number of patients. Data for the 0–12-month change in the EDSS score were taken from Ziemssen T, Lang M, Tackenberg B et al. Clinical and demographic profile of patients receiving fingolimod in clinical practice in Germany and the benefit–risk profile of fingolimod after 1 year of treatment: initial results from the observational, noninterventional study PANGAEA. Neurotherapeutics 2018;15:190–199, with the permission of the copyright holders (authors).

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    Figure 3 Freedom from clinical disease activity during 36 months of fingolimod treatment

    Mean proportion of patients who were free from relapses and 6-month confirmed disability progression during each 12-month follow-up period and in the overall 36-month follow-up period following fingolimod initiation. Error bars show 95% CI. N = number of patients. Data for the 0–12-month period were taken from Ziemssen T, Lang M, Tackenberg B et al. Clinical and demographic profile of patients receiving fingolimod in clinical practice in Germany and the benefit–risk profile of fingolimod after 1 year of treatment: initial results from the observational, noninterventional study PANGAEA. Neurotherapeutics 2018;15:190–199, with the permission of the copyright holders (authors).

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