International Delphi Consensus on the Management of AQP4-IgG+ NMOSD
Recommendations for Eculizumab, Inebilizumab, and Satralizumab
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Article Information
- Received August 17, 2022
- Accepted in final form March 27, 2023
- First Published May 31, 2023.
Author Disclosures
- Friedemann Paul, MD,
- Romain Marignier, PhD,
- Jacqueline Palace, MD, PhD,
- Georgina Arrambide, MD, PhD,
- Nasrin Asgari, MD, PhD, DMSc,
- Jeffrey L. Bennett, MD, PhD,
- Bruce Anthony Campbell Cree, MD, PhD, MAS,
- Jérôme De Sèze, MD, PhD,
- Kazuo Fujihara, MD,
- Ho Jin Kim, MD, PhD,
- Rebecca Hornby, PhD,
- Saif Huda, MD, DPhil,
- Najib Kissani, MD,
- Ingo Kleiter, MD,
- Satoshi Kuwabara, MD, PhD,
- Marco Lana-Peixoto, MD, PhD,
- Lisa Law, MSc,
- M. Isabel Leite, MD, DPhil,
- Lekha Pandit, MD, PhD,
- Sean J. Pittock, MD,
- Chao Quan, MD, PhD,
- Sudarshini Ramanathan, FRACP, PhD,
- Dalia Rotstein, MD, MPH,
- Albert Saiz, MD, PhD,
- Douglas Kazutoshi Sato, MD, PhD and
- Adi Vaknin-Dembinsky, MD
- Friedemann Paul, MD,
Novartis OCTIMS study steering committeeMedImmune / Viela Bio steering committee
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br>speaker honoraria and travel grants from Bayer, Novartis, Biogen Idec, Teva, Sanofi-Aventis / Genzyme, and Merck Serono, Alexion, Chugai, MedImmune, Shire, Roche, Actelion, Celgene
Academic Editor, PLoS ONEAssociate Editor, Neurology Neuroimmunology andNeuroinflammation
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consultancies for SanofiGenzyme, BiogenIdec, MedImmune, Shire, Alexion, Hoffmann-La Roche, Celegene, Horizon Therapeutics, Merck, Neurogenesis Ltd.
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Research support from from Bayer, Novartis, Biogen Idec, Teva, Sanofi-Aventis / Genzyme, Alexion and Merck Serono
German Research Council (DFG Exc 257), Werth Stiftung of the City of Cologne, German Ministry ofEducation and Research (BMBF Competence Network MultipleSclerosis), Arthur Arnstein Stiftung Berlin, EU FP7Framework Program (combims.eu)
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Arthur Arnstein Foundation Berlin, Guthy JacksonCharitable Foundation, National Multiple Sclerosis Societyof the USA
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- Romain Marignier, PhD,
Dr Marignier is serving on a scientific advisory board ofAlexion, Horizon Therapeutics, Roche and UCB
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Romain Marignier has received lecturing fees and travel grants from Biogen, Horizon Therapeutics, Novartis, Roche, Sanofi, Alexion, UCB
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- Jacqueline Palace, MD, PhD,
1) Merck Serono 2) Roche 3) ARGENX 4) Novartis 5) UCB 6) Alexion 7)Janssen8) Sanofi
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All commercial (speakers/meetings honorarium last two years)1) Roche 2) Alexion 3) Chugai
Lancet Neurology editorial advisorry committee member
ISIS Innovation Ltd. To protect for the use ofmetabolomics as a method to diagnose and stage disease inmultiple sclerosis. Patent ref P37347WO and licence agreement Numares multimarker MS diagnostics
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Amplo
Please see 3 (speaker/meetings)
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All commercial (support for research)1) Amplo 2) UCB3) Alexion4)Medimmune
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Grant for research:1) Multiple Sclerosis Society4) SPARKS Great Ormond Street
Astra Zenica shares
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Patent ref P37347WO and licence agreement Numares multimarker MS diagnostics
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- Georgina Arrambide, MD, PhD,
(1) Sanofi advisory board on BTK inhibitors.(2) Merck advisory board on evobrutinib.(3) Roche advisory board on satralizumab.(4) Horizon Therapeutics advisory board on inebilizumab.
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(1) Speaking honoraria from Merck.(2) Travel support for scientific meetings from Novartis.(3) Travel support for scientific meetings from Roche.(4) Travel support for scientific meetings from ECTRIMS.
(1) Multiple Sclerosis Journal - Experimental, Translational and Clinical editor for Europe(2) Acta Neurológica Colombiana (editorial advisory board member)
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(1) Instituto de Salud Carlos III, ayudas de investigación en salud, FIS number PI19/01590, principal investigator, 2019-2022, extended to June 2024(2) Instituto de Salud Carlos III, ayudas de investigación en salud, FIS number PI22/01570, principal investigator, 2022-2025
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- Nasrin Asgari, MD, PhD, DMSc,
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The University of Southern Denmark, 2022
The University of Southern Denmark
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- Jeffrey L. Bennett, MD, PhD,
(1) Alexion (2) Roche (3) IMCYSE SA (4) Genentech (5) Horizon Therapeutics (6) TG Therapeutics (7) EMD Serono
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Editorial Board, Journal of Neuro-ophthalmologyEditorial Board, Multiple Sclerosis JournalEditorial Board, Neurology: Neuroimmunology & Neuroinflammation
(1) Compositions and Methods for the Treatment of Neuromyelitis Optica; novel blocking monoclonal therapy for neuromyelitis optica: US Patent: 10,654,916
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(1) Reistone-Bio. (2) Horizon Therapeutics, (3) Chugai Pharma USA, (4) Mitsubishi Tanabe, (5) Alexion Pharmaceuticals, (6) Genentech, (7) Roche, (8) Antigenomycs, (9) EMD Serono, (10) Beigene
(1) Alexion Pharmaceuticals
(1) Clene Nanomedicine, data safety monitoring board, (2) Roche, data safety monitoring board
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(1) Alexion
(1) National Institutes of Health, R01NS115488, R01EY022936, R21EY032399, Principal investigator, 2020-2022
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(1) Guthy Jackson Charitable Foundation
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(1) Aquaporumab, rights for future royalty payments
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- Bruce Anthony Campbell Cree, MD, PhD, MAS,
Data safety monitoring board: Immunic AG
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Alexion, Atara, Autobahn, Avotres, Biogen, Boston Pharma, EMD Serono, Gossamer Bio, Hexal/Sandoz, Horizon, Neuron23, Novartis, Sanofi, Siemens, TG Therapeutics
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Genentech
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- Jérôme De Sèze, MD, PhD,
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Revue Neurologique
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- Kazuo Fujihara, MD,
Serves on scientific advisory boards for Biogen, Mitsubishi-Tanabe, Novartis, Roche/Chugai, Alexion, VielaBio/Horizon Therapeutics, UCB, Abbvie and Japan Tobacco.
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has received funding for travel or speaker honoraria from Roche/Chugai, Biogen, Novartis, Alexion, Teijin, Mitsubishi-Tanabe, AsahiKasei Medical, Merck, Eisai,and Takeda.
Serve as an editorial board member of Clinical and Experimental Neuroimmunology (2009-present), Frontiers in Neurology (2017-present), Neurology: Neuroimmunology and Neuroinflammation (2018-present), Multiple Sclerosis (2019-present), Multiple Sclerosis and Related Disorders (2020-present) and Neuroimmunology Reports (2021-present) and advisory board member of Sri Lanka journal of Neurology.
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funded as the investigator by the Grants-in-Aid for Scientific Research from the Ministry of Health, Welfare and Labor of Japan (2010–present).
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- Ho Jin Kim, MD, PhD,
Roche, Sanofi Genzyme and Horizon Therapeutics (formerly Viela Bio)
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Received travel expenses and/or honoraria for lectures or educational activities from Alexion, Biogen, Celltrion, Eisai, GC Pharma, Mitsubishi Tanabe Pharma, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva-Handok
Multiple Sclerosis Journal, Coeditor, 2019Journal of Clinical Neurology, Associate Editor, 2016
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Aprilbio, Daewoong, HanAll BioPharma, MDimune, Merck Serono, Roche, Sanofi Genzyme, and UCB
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National Research Foundation of Korea, 2018R1A5A2023127, , Co-Principal Investigator, 2018
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- Rebecca Hornby, PhD,
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Rebecca Hornby is an employee of Oxford PharmaGenesis Ltd which has received funding from F. Hoffmann-La Roche Ltd for medical writing support.
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- Saif Huda, MD, DPhil,
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(1) AlphaSights (2) Atheneum
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- Najib Kissani, MD,
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- Ingo Kleiter, MD,
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Alexion, Biogen, Celgene, Horizon, Merck, Roche
BMC Neurology, associate editor, since 2018Neuroimmunology Reports, editorial board member, since 2020Frontiers in Neurology, associate editor, since 2022Frontiers in Immunology, associate editor, since 2022
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Alexion, Almirall, Bayer, Biogen, Hexal, Horizon, Merck, Neuraxpharm, Roche, Sanofi
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- Satoshi Kuwabara, MD, PhD,
(1) non-profit entity: Deputy Editor, Journal of Neurology, Neurosurgery, and Psychiatry.(2) non-profit entity: Editorial Board member, Journal of the Neurological Sciences.
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(1)Associate Editor, Journal of Neurology, Neurosurgery, and Psychiatry, since 2010 to present.(2)Editorial board member, Journal of the Neurological Sciences, since 2013 to present.
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(1) The the Health and Labour SciencesResearch Grant on Intractable Diseases (Neuroimmunological Diseases) from the Ministry of Health, Labour and Welfare of Japan (20FC1030).
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- Marco Lana-Peixoto, MD, PhD,
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Funding for travel from Novartis Funding for travel from Biogen
(1)Arquivos de Neuro-Psiquiatria - Member of the Advisory Editorial Board(2) Frontiers in Medicine - Member of the Editorial Board
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Support for paper publication from Roche
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- Lisa Law, MSc,
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Lisa Law is an employee of Oxford PharmaGenesis, which has received funding from F. Hoffmann-La Roche Ltd for medical writing support
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- M. Isabel Leite, MD, DPhil,
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Dr. Maria Isabel Leite is supported by NHS National Specialised Commissioning Group for Neuromyelitis Optica, UK, and by NIHR Oxford Biomedical Research Centre, and has received travel grant and speaking honoraria from Biogen Idec and travel grant from Novartis.
Neuromuscular Disorders, editorial board member, from January 2014
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- Lekha Pandit, MD, PhD,
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- Sean J. Pittock, MD,
Alexion Pharmaceutical Advisory Board - Compensation to Mayo Clinic Medimmune/Viele Bio Advisory Board - Compensation to Mayo ClinicUCB pharmaceuticals - Personal compensationHoffman/LaRoche - Personal compensationRoche/Genentech - Personal compensation
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Dr. Pittock has a patent Patent# 8,889,102 (Application#12-678350) - Neuromyelitis Optica Autoantibodies as a Marker for Neoplasia issued, and a patent Patent# 9,891,219B2 (Application#12-573942) - Methods for Treating Neuromyelitis Optica (NMO) by Administration of Eculizumab to an individual that is Aquaporin-4 (AQP4)-IgG Autoantibody positive issued. Dr Pittock has received royalies relating to this patent. Dr Pittock has a patent pending for GFAP, Septin-5, Kelch11, LUZP4, Cav4 and MAP1B autoantibodies as biomarkers of neurological autoimmunity.
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Dr. Pittock has provided consultation to Alexion Pharmaceuticals and Medimmune/Viela Bio but has received no personal fees or personal compensation for these consulting activities. All compensation for consulting activities is paid directly to Mayo Clinic.Dr. Pittock provided consultation to Astellas- Compensation to Mayo and personal compensation. Dr. Pittock received personal compensation for consultation services to UCB, Genentech, Arialys Therapeutics, Sage Therapeutics, and Prime Therapeutics.
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No activity to report. I am a salaried employee of Mayo Clinic and salary is fixed specialty dependent and not impacted by test volume or laboratory income.
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Dr Pittock has received research funding from Grifols, Medimmune/Viela Bio, Alexion, the National Institute of Health (NIH), NovelMed, and Genentech/F. Hoffman-LaRoche. All compensation is paid directly to Mayo Clinic.
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- Chao Quan, MD, PhD,
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(1) Neuroimmunology Reports, editorial board member,2 years
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National Natural Science Foundation of China, No.82171341, principal investigator,2022-2025
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- Sudarshini Ramanathan, FRACP, PhD,
Dr Ramanathan has served as a consultant on an advisory board for UCB.
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Speaker honoraria from Biogen and Limbic Neurology.
Editorial board member Neurology Neuroimmunology and Neuroinflammation (2022 onwards), and Frontiers in Immunology and Frontiers in Neurology (2021 onwards).
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Dr Ramanathan is the recipient of an National Health and Medical Research Council Investigator Grant, and has received research funding support from the University of Sydney in the form of research grants.
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Dr Ramanathan has received research funding from the Brain Foundation (Australia), the Petre Foundation (Australia), and the Royal Australasian College of Physicians.
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- Dalia Rotstein, MD, MPH,
(1) Biogen(2) Sanofi Aventis(3) EMD Serono(4) Alexion(5) Roche(6) Novartis
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(1) Sanofi Aventis(2) Roche(3) Novartis(4) EMD Serono(5) Alexion (6) Biogen
Frontiers in Neurology, Associate Editor, 2019-2022
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(1) Sanofi Aventis(2) Roche(3) Alexion(4) Biogen(5) EMD Serono(6) Novartis
(1) Alexion(2) Biogen(3) EMD Serono(4) Novartis(5) Roche(6) Sanofi Aventis
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I have received research support from Roche.
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University of Toronto Division of Neurology
I have received research support from the National MS Society, MS Canada, and the Consortium for Multiple Sclerosis Centers (CMSC).
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- Albert Saiz, MD, PhD,
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compensation for consulting services and speaker honoraria from Merck-Serono, Biogen-Idec, Sanofi, Novartis, Roche, Alexion, Janssen, and Horizon Therapeutics
Editorial advisory board member: Neurol Neuroimmunol Neuroinflamm
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- Douglas Kazutoshi Sato, MD, PhD and
(1) Alexion - advisory board; (2) Horizon - advisory board; (3) - Roche - advisoryboard
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(1) Speaker honoraria from Horizon, (2) Speaker honoraria from Merck, (3) Speaker honoraria from Roche
Associate editor of Arquivos de Neuropsiquiatria (2013-2018 and 2022-current), no compensation
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(1) TEVA, (2) Merck, (3) Biogen
CAPES/Brazil (PROEX program 001), CNPq/Brazil (425331/2016-4 and 308636/2019-8), FAPERGS/Brazil (17/2551-0001391-3 and 21/2551-0000077-5),
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- Adi Vaknin-Dembinsky, MD
Served on scientific advisory boards for F. Hoffmann-La Roche, Biogen, Merck-serono and Sanofi-Aventis; Astra Zenica and Novartis
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speaker honoraria for , Biogen, Merck-serono.
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received grants from F. Hoffmann-La Roche, Biogen and Merck-Serono.
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- From the Experimental and Clinical Research Center (F.P.), Max Delbrueck Center for Molecular Medicine and Charité Universitaetsmedizin Berlin, Germany; Hospices Civils de Lyon (R.M.), Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro Inflammation, and Centre de Référence des Maladies Inflammatoires Rares du Cerveau et de la Moelle (MIRCEM), Hôpital Neurologique Pierre Wertheimer, Bron; Centre des Neurosciences de Lyon—FORGETTING Team (R.M.), INSERM 1028 et CNRS UMR5292; Université Claude Bernard Lyon 1 (R.M.), France; John Radcliff Hospital (J.P.); Clinical Neurology Oxford University (J.P.), Oxford, United Kingdom; Servei de Neurologia-Neuroimmunologia (G.A.), Centre d’Esclerosi Múltiple de Catalunya (Cemcat); Vall d’Hebron Institut de Recerca (G.A.), Vall d’Hebron Hospital Universitari; Universitat Autònoma de Barcelona (G.A.), Spain; Departments of Regional Health Research and Molecular Medicine (N.A.), University of Southern Denmark, Odense, Denmark; Department of Neurology (N.A.), Slagelse Hospital, Denmark; Programs in Neuroscience and Immunology (J.L.B.), Departments of Neurology and Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora; Department of Neurology (B.A.C.C.), UCSF Weill Institute for Neurosciences, University of California San Francisco; Department of Neurology (J.D.S.), Hôpitaux Universitaires de Strasbourg; INSERM U1119 Biopathologie de la Myéline (J.D.S.), Neuroprotection et Stratégies Thérapeutique; Clinical Investigation Center (J.D.S.), Hôpitaux Universitaires de Strasbourg, France; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University School of Medicine, and Multiple Sclerosis and Neuromyelitis Optica Center, Southern TOHOKU Research Institute for Neuroscience, Koriyama, Japan; Department of Neurology (H.J.K.), Research Institute and Hospital of National Cancer Center, Goyang, South Korea; Oxford PharmaGenesis Ltd (R.H., L.L.); Department of Neurology (S.H.), Walton Centre NHS Foundation Trust, Liverpool, United Kingdom; Medical Research Center (N.K.), Marrakesh Medical School, Cadi Ayyad University; Neurology Department (N.K.), University Teaching Hospital Mohammed VI, Marrakesh, Morocco; Department of Neurology (I.K.), St Josef-Hospital, Ruhr-University Bochum; Marianne-Strauß-Klinik (I.K.), Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke, Berg, Germany; Department of Neurology (S.K.), Graduate School of Medicine, Chiba University, Japan; CIEM MS Research Center (M.L.-P.), Federal University of Minas Gerais, Belo Horizonte, Brazil; John Radcliffe Hospital (M.I.L.), University of Oxford, United Kingdom; KS Hegde Medical Academy Director (L.P.), Center for Advanced Neurological Research, Nitte University, Mangalore, India; Neurology (S.J.P.), Laboratory Medicine and Pathology, Center for Multiple Sclerosis and Autoimmune Neurology, Mayo Clinic, Rochester, MN; Department of Neurology and Rare Disease Center (C.Q.), National Center for Neurological Disorders, Huashan Hospital, Shanghai Medical College, Fudan University, China; Translational Neuroimmunology Group (S.R.), Kids Neuroscience Centre, and Brain and Mind Centre, Sydney Medical School, Faculty of Medicine and Health, University of Sydney; Department of Neurology (S.R.), Concord Hospital, Australia; Division of Neurology (D.R.), Department of Medicine, University of Toronto, Ontario, Canada; Neuroimmunology and Multiple Sclerosis Unit (A.S.), Service of Neurology, Hospital Clinic, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), and Universitat de Barcelona, Spain; School of Medicine (D.K.S.), Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil; and Department of Neurology and Laboratory of Neuroimmunology and The Agnes-Ginges Center for Neurogenetics (A.V.-D.), Hadassah-Medical Center, Ein–Kerem, Faculty of Medicine, Hebrew University of Jerusalem, Israel.
- Correspondence
Dr. Paul friedemann.paul{at}charite.de
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