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January 2023; 10 (1) Research ArticleOpen Access

Long-term Efficacy of Satralizumab in AQP4-IgG–Seropositive Neuromyelitis Optica Spectrum Disorder From SAkuraSky and SAkuraStar

View ORCID ProfileIngo Kleiter, View ORCID ProfileAnthony Traboulsee, Jacqueline Palace, Takashi Yamamura, Kazuo Fujihara, Albert Saiz, Adil Javed, David Mayes, H-Christian von Büdingen, Gaelle Klingelschmitt, Daniela Stokmaier, Jeffrey L. Bennett
First published December 8, 2022, DOI: https://doi.org/10.1212/NXI.0000000000200071
Ingo Kleiter
From the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
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Anthony Traboulsee
From the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
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Jacqueline Palace
From the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
DM
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Takashi Yamamura
From the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
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Kazuo Fujihara
From the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
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Albert Saiz
From the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
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Adil Javed
From the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
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David Mayes
From the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
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H-Christian von Büdingen
From the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
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Gaelle Klingelschmitt
From the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
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Daniela Stokmaier
From the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
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Jeffrey L. Bennett
From the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
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Citation
Long-term Efficacy of Satralizumab in AQP4-IgG–Seropositive Neuromyelitis Optica Spectrum Disorder From SAkuraSky and SAkuraStar
Ingo Kleiter, Anthony Traboulsee, Jacqueline Palace, Takashi Yamamura, Kazuo Fujihara, Albert Saiz, Adil Javed, David Mayes, H-Christian von Büdingen, Gaelle Klingelschmitt, Daniela Stokmaier, Jeffrey L. Bennett
Neurol Neuroimmunol Neuroinflamm Jan 2023, 10 (1) e200071; DOI: 10.1212/NXI.0000000000200071

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    Figure 1 Flowchart of AQP4-IgG Seropositive Patients in the SAkura Studies

    *One patient joined directly into the OLE and remained in the trial at the cutoff for the current analysis (February 22, 2021). Where patients withdrew consent, this applied to all data collection from that point onward, not prior. AQP4-IgG = aquaporin-4-immunoglobulin G; CCOD = clinical cutoff date; DB = double-blind; OLE = open-label extension; R = randomization.

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    Figure 2 Kaplan-Meier Analysis of Time to First iPDR in the Total Satralizumab Treatment Periods of (A) SAkuraSky and (B) SAkuraStar

    PBO = placebo; SAT = satralizumab.

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    Figure 3 Swim Plot of iPDR Events in All Patients Who Received Satralizumab in SAkuraSky and SAkuraStar

    iPDR = investigator-reported protocol-defined relapse.

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    Figure 4 Kaplan-Meier Analysis of Time to First Severe iPDR in the Total Satralizumab Treatment Periods of (A) SAkuraSky and (B) SAkuraStar

    iPDR = investigator-reported protocol-defined relapse; PBO = placebo; SAT = satralizumab.

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    Figure 5 Kaplan-Meier Analysis of Time to First Sustained EDSS Worsening in the Total Satralizumab Treatment Periods of (A) SAkuraSky and (B) SAkuraStar

    EDSS = Expanded Disability Status Scale; PBO = placebo; SAT = satralizumab.

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