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1. Severity of COVID19 infection among patients with multiple sclerosis treated with interferon-β.

Author

Simpson-Yap S, Pirmani A, De Brouwer E, Peeters LM, Geys L, Parciak T, Helme A, Hillert J, Moreau Y, Edan G, Spelman T, Sharmin S, McBurney R, Schmidt H, Bergmann A, Braune S, Stahmann A, Middleton R, Salter A, Bebo B, van der Walt A, Butzkueven H, Ozakbas S, Karabudak R, Boz C, Alroughani R, Rojas JI, van der Mei I, Sciascia do Olival G, Magyari M, Alonso R, Nicholas R, Chertcoff A, Zabalza A, Arrambide G, Nag N, Descamps A, Costers L, Dobson R, Miller A, Rodrigues P, Prčkovska V, Comi G, and Kalincik T

Subjects
Acetates, Dimethyl Fumarate therapeutic use, Glatiramer Acetate therapeutic use, Humans, Immunosuppressive Agents adverse effects, Interferon-beta therapeutic use, COVID-19, Multiple Sclerosis chemically induced, Multiple Sclerosis complications, Multiple Sclerosis drug therapy, Multiple Sclerosis, Relapsing-Remitting chemically induced
Abstract

Background: Interferon-β, a disease-modifying therapy (DMT) for MS, may be associated with less severe COVID-19 in people with MS., Results: Among 5,568 patients (83.4% confirmed COVID-19), interferon-treated patients had lower risk of severe COVID-19 compared to untreated, but not to glatiramer-acetate, dimethyl-fumarate, or pooled other DMTs., Conclusions: In comparison to other DMTs, we did not find evidence of protective effects of interferon-β on the severity of COVID-19, though compared to the untreated, the course of COVID19 was milder among those on interferon-β. This study does not support the use of interferon-β as a treatment to reduce COVID-19 severity in MS., Competing Interests: Declaration of Competing Interest Steve Simpson-Yap has no conflicts of interests to disclose. Ashkan Pirmani has no conflicts of interests to disclose. Edward De Brouwer has no conflicts of interests to disclose. Liesbet M. Peeters has no personal pecuniary interests to disclose, other than being the chair of The MS Data Alliance (MSDA), which received income from a range of corporate sponsors, recently including Biogen, BristolMyersSquibb (formerly Celgene), Janssen Pharmaceuticals, Merck, Novartis, QMENTA, and Roche. Lotte Geys has no other conflicts of interests to disclose than that she is funded by the Flemish Government under the “Onderzoeksprogramma Artificiële Intelligentie Vlaanderen”. Tina Parciak has no conflicts of interests to disclose. Anne Helme has no personal pecuniary interests to disclose, other than being an employee of the MS International Federation, which receives income from a range of corporate sponsors, recently including: Biogen, BristolMyersSquibb, Janssen, Sanofi, Merck, Mylan, Novartis, and Roche – all of which is publicly disclosed. Jan Hillert has received honoraria for serving on advisory boards for Biogen, Celgene, Sanofi-Genzyme, Merck KGaA, Novartis and Sandoz and speaker's fees from Biogen, Novartis, Merck KGaA, Teva and Sanofi-Genzyme, has served as principal investigator for projects, or received unrestricted research support from Biogen, Celgene, Merck KGaA, Novartis, Roche and Sanofi-Genzyme, and his MS research was funded by the Swedish Research Council and the Swedish Brain foundation. Yves Moreau has no conflicts of interests to disclose. Gilles Edan has received consulting/speaking fees and research support from Bayer, Novartis, Teva, Sanofi Genzyme, Merck Serono, Biogen Idec, and Roche. Tim Spelman served on scientific advisory boards for Biogen. Sifat Sharmin has no conflicts of interests to disclose. Robert McBurney works for the Accelerated Cure Project for MS (ACP), which has received grants, collaboration funding, payments for use of assets, or in-kind contributions from the following companies: EMD Serono, Sanofi/Genzyme, Biogen, Genentech, AbbVie, Octave, GlycoMinds, Pfizer, MedDay, AstraZeneca, Teva, Mallinckrodt, MSDx, Regeneron Genetics Center, BC Platforms, and Celgene. ACP has also received funding from the Patient-Centered Outcomes Research Institute (PCORI) and the National MS Society (NMSS). RMcB. has received consulting payments from EMD Serono, which have been donated to ACP. Hollie Schmidt works for the Accelerated Cure Project for MS (ACP), which has received grants, collaboration funding, payments for use of assets, or in-kind contributions from the following companies: EMD Serono, Sanofi/Genzyme, Biogen, Genentech, AbbVie, Octave, GlycoMinds, Pfizer, MedDay, AstraZeneca, Teva, Mallinckrodt, MSDx, Regeneron Genetics Center, BC Platforms, and Celgene. ACP has also received funding from the Patient-Centered Outcomes Research Institute (PCORI) and the National MS Society (NMSS). Arnfin Bergmann has received consulting fees from and is an advisory board/speaker/other activities for NeuroTransData, and has worked on project management/clinical studies for and received travel expenses from Novartis and Servier. Stefan Braune receives fees for consulting, clinical studies and lectures from NeuroTransData, Novartis, Celgene, Biogen, CSl Behring. Alexander Stahmann has no personal pecuniary interests to disclose, other than being the lead of the German MS-Registry, which receives (project) funding from a range of public and corporate sponsors, recently including The German Innovation Fund (G-BA), The German MS Trust, Biogen, German MS Society, Celgene (BMS), Merck, Novartis, Roche, and Sanofi. Rodden Middleton has received no personal funding from any sources, the UK MS Register is funded by the MS Society and has received funding for specific projects from Novartis, Sanofi-Genzyme and Merck KGaA. Amber Salter is on the editorial board for Neurology and received research funding from the Department of Defense, National MS Society and the Consortium of MS Centers. Bruce Bebo has no conflicts of interests to disclose. Anneke van der Walt has received honoraria and unrestricted research funding from Novartis, Biogen, Roche, Merck and Sanofi. Helmut Butzkueven's institution receives compensation for Advisory Board, Steering Committee and Educational activities from Biogen, Roche, Merck, and Novartis. His-institution receives research support from Roche, Novartis, Biogen, NHMRC and MRFF Australia, MS Research Australia and the Trish MS Foundation. He receives personal compensation from Oxford HPF for serving on the steering group of MS Brain Health. Serkan Ozakabas has no conflicts of interests to disclose. Rana Karabudak has received honoraria for educational lectures, consultancy fees for participating advisory boards, and travel grants for attending scientific congresses or symposia from Roche, Sanofi-Genzyme, Merck-Serono, Novartis, Teva, Biogen Idec/Gen Pharma of Turkey, Abdi İbrahim İlaç, Deva and ARIS. Cavit Boz received conference travel support from Biogen, Novartis, Roche, Merck and Teva, and has participated in clinical trials by Sanofi Aventis, Roche and Novartis. Raed Alroughani has received honoraria as a speaker and for serving in scientific advisory boards from Bayer, Novartis, Roche, Sanofi, Merck and Biogen. Juan I Rojas has received honoraria from Novartis as a scientific advisor, and has received travel grants and attended courses and conferences on behalf of Merck-Serono Argentina, Novartis Argentina. Ingrid van der Mei has no conflicts of interests to disclose. Guilherme Sciascia do Olival has no relevant conflicts of interests to disclose. Melinda Magyari has served on scientific advisory board for Biogen, Sanofi, Roche, Novartis, Merck, Abbvie, has received honoraria for lecturing from Biogen, Merck, Novartis, Sanofi, Genzyme, and has received research support and support for congress participation from Biogen, Genzyme, Roche, Merck, Novartis. Ricardo Alonso has received honoraria from Novartis as a scientific advisor, travel grants and attended courses and conferences on behalf of Merck-Serono Argentina, Biogen Argentina, Genzyme Argentina, Roche Argentina and Novartis Argentina. Richard Nicholas has received honoraria from Novartis, Roche and Biogen for advisory boards. Anibal Chertcoff has no conflicts of interests to disclose. Ana Zabalza has received travel expenses for scientific meetings from Biogen, Novartis, and Genzyme, speaking honoraria from Eisai, and a study grant from Novartis. Georgina Arrambide has received compensation for consulting services or participation in advisory boards from Sanofi, Merck and Roche, research support from Novartis, travel expenses for scientific meetings from Novartis, Roche, Stendhal, and ECTRIMS, speaking honoraria from Sanofi and Merck, and is a member of the International Women in Multiple Sclerosis (iWiMS) network executive committee. Nupur Nag has no conflicts of interests to disclose. Annabel Descamps has no conflicts of interests to disclose. Lars Costers has no conflicts of interests to disclose. Ruth Dobson has participated in advisory boards for Merck, Biogen, Janssen, Novartis and Roche. Grant support from Biogen, Merck and Celgene. Aleisha Miller has no conflicts of interests to disclose. Paulo Rodrigues is a shareholder, employee and member of board of directors of QMENTA. Vesna Prchkovska is a shareholder, employee and member of board of directors of QMENTA. Giancarlo Comi has received consulting and speaking fees from Novartis, Teva Pharmaceutical Industries Ltd, Teva Italia Srl, Sanofi Genzyme, Genzyme Corporation, Genzyme Europe, Merck KGgA, Merck Serono SpA, Celgene Group, Biogen Idec, Biogen Italia Srl, F. Hoffman-La Roche, Roche SpA, Almirall SpA, Forward Pharma, Medday and Excemed. Tomas Kalincik has served on scientific advisory boards for Roche, Sanofi-Genzyme, Novartis, Merck and Biogen, steering committee for Brain Atrophy Initiative by Sanofi-Genzyme, received conference travel support and/or speaker honoraria from WebMD Global, Novartis, Biogen, Sanofi-Genzyme, Teva, BioCSL and Merck and received research support from Biogen., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Published
2022
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2. Updated Results of the COVID-19 in MS Global Data Sharing Initiative: Anti-CD20 and Other Risk Factors Associated With COVID-19 Severity.

Author

Simpson-Yap S, Pirmani A, Kalincik T, De Brouwer E, Geys L, Parciak T, Helme A, Rijke N, Hillert JA, Moreau Y, Edan G, Sharmin S, Spelman T, McBurney R, Schmidt H, Bergmann AB, Braune S, Stahmann A, Middleton RM, Salter A, Bebo B, Van der Walt A, Butzkueven H, Ozakbas S, Boz C, Karabudak R, Alroughani R, Rojas JI, van der Mei IA, Sciascia do Olival G, Magyari M, Alonso RN, Nicholas RS, Chertcoff AS, de Torres AZ, Arrambide G, Nag N, Descamps A, Costers L, Dobson R, Miller A, Rodrigues P, Prčkovska V, Comi G, and Peeters LM

Subjects
Antigens, CD20, Glatiramer Acetate therapeutic use, Humans, Immunosuppressive Agents therapeutic use, Information Dissemination, Male, Natalizumab therapeutic use, Risk Factors, Rituximab therapeutic use, COVID-19, Multiple Sclerosis drug therapy, Multiple Sclerosis epidemiology, Multiple Sclerosis, Chronic Progressive drug therapy
Abstract

Background and Objectives: Certain demographic and clinical characteristics, including the use of some disease-modifying therapies (DMTs), are associated with severe acute respiratory syndrome coronavirus 2 infection severity in people with multiple sclerosis (MS). Comprehensive exploration of these relationships in large international samples is needed., Methods: Clinician-reported demographic/clinical data from 27 countries were aggregated into a data set of 5,648 patients with suspected/confirmed coronavirus disease 2019 (COVID-19). COVID-19 severity outcomes (hospitalization, admission to intensive care unit [ICU], requiring artificial ventilation, and death) were assessed using multilevel mixed-effects ordered probit and logistic regression, adjusted for age, sex, disability, and MS phenotype. DMTs were individually compared with glatiramer acetate, and anti-CD20 DMTs with pooled other DMTs and with natalizumab., Results: Of 5,648 patients, 922 (16.6%) with suspected and 4,646 (83.4%) with confirmed COVID-19 were included. Male sex, older age, progressive MS, and higher disability were associated with more severe COVID-19. Compared with glatiramer acetate, ocrelizumab and rituximab were associated with higher probabilities of hospitalization (4% [95% CI 1-7] and 7% [95% CI 4-11]), ICU/artificial ventilation (2% [95% CI 0-4] and 4% [95% CI 2-6]), and death (1% [95% CI 0-2] and 2% [95% CI 1-4]) (predicted marginal effects). Untreated patients had 5% (95% CI 2-8), 3% (95% CI 1-5), and 1% (95% CI 0-3) higher probabilities of the 3 respective levels of COVID-19 severity than glatiramer acetate. Compared with pooled other DMTs and with natalizumab, the associations of ocrelizumab and rituximab with COVID-19 severity were also more pronounced. All associations persisted/enhanced on restriction to confirmed COVID-19., Discussion: Analyzing the largest international real-world data set of people with MS with suspected/confirmed COVID-19 confirms that the use of anti-CD20 medication (both ocrelizumab and rituximab), as well as male sex, older age, progressive MS, and higher disability are associated with more severe course of COVID-19., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.)

Published
2022
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3. Associations of Disease-Modifying Therapies With COVID-19 Severity in Multiple Sclerosis.

Author

Simpson-Yap S, De Brouwer E, Kalincik T, Rijke N, Hillert JA, Walton C, Edan G, Moreau Y, Spelman T, Geys L, Parciak T, Gautrais C, Lazovski N, Pirmani A, Ardeshirdavanai A, Forsberg L, Glaser A, McBurney R, Schmidt H, Bergmann AB, Braune S, Stahmann A, Middleton R, Salter A, Fox RJ, van der Walt A, Butzkueven H, Alroughani R, Ozakbas S, Rojas JI, van der Mei I, Nag N, Ivanov R, Sciascia do Olival G, Dias AE, Magyari M, Brum D, Mendes MF, Alonso RN, Nicholas RS, Bauer J, Chertcoff AS, Zabalza A, Arrambide G, Fidao A, Comi G, and Peeters L

Subjects
Adolescent, Adult, Aged, Antibodies, Monoclonal, Humanized adverse effects, Antibodies, Monoclonal, Humanized therapeutic use, COVID-19 pathology, COVID-19 physiopathology, Cross-Sectional Studies, Dimethyl Fumarate adverse effects, Dimethyl Fumarate therapeutic use, Female, Humans, Male, Middle Aged, Natalizumab adverse effects, Natalizumab therapeutic use, Respiration, Artificial statistics & numerical data, Rituximab adverse effects, Rituximab therapeutic use, SARS-CoV-2, Young Adult, COVID-19 complications, Hospitalization statistics & numerical data, Multiple Sclerosis complications, Multiple Sclerosis drug therapy
Abstract

Background and Objectives: People with multiple sclerosis (MS) are a vulnerable group for severe coronavirus disease 2019 (COVID-19), particularly those taking immunosuppressive disease-modifying therapies (DMTs). We examined the characteristics of COVID-19 severity in an international sample of people with MS., Methods: Data from 12 data sources in 28 countries were aggregated (sources could include patients from 1-12 countries). Demographic (age, sex), clinical (MS phenotype, disability), and DMT (untreated, alemtuzumab, cladribine, dimethyl fumarate, glatiramer acetate, interferon, natalizumab, ocrelizumab, rituximab, siponimod, other DMTs) covariates were queried, along with COVID-19 severity outcomes, hospitalization, intensive care unit (ICU) admission, need for artificial ventilation, and death. Characteristics of outcomes were assessed in patients with suspected/confirmed COVID-19 using multilevel mixed-effects logistic regression adjusted for age, sex, MS phenotype, and Expanded Disability Status Scale (EDSS) score., Results: Six hundred fifty-seven (28.1%) with suspected and 1,683 (61.9%) with confirmed COVID-19 were analyzed. Among suspected plus confirmed and confirmed-only COVID-19, 20.9% and 26.9% were hospitalized, 5.4% and 7.2% were admitted to ICU, 4.1% and 5.4% required artificial ventilation, and 3.2% and 3.9% died. Older age, progressive MS phenotype, and higher disability were associated with worse COVID-19 outcomes. Compared to dimethyl fumarate, ocrelizumab and rituximab were associated with hospitalization (adjusted odds ratio [aOR] 1.56, 95% confidence interval [CI] 1.01-2.41; aOR 2.43, 95% CI 1.48-4.02) and ICU admission (aOR 2.30, 95% CI 0.98-5.39; aOR 3.93, 95% CI 1.56-9.89), although only rituximab was associated with higher risk of artificial ventilation (aOR 4.00, 95% CI 1.54-10.39). Compared to pooled other DMTs, ocrelizumab and rituximab were associated with hospitalization (aOR 1.75, 95% CI 1.29-2.38; aOR 2.76, 95% CI 1.87-4.07) and ICU admission (aOR 2.55, 95% CI 1.49-4.36; aOR 4.32, 95% CI 2.27-8.23), but only rituximab was associated with artificial ventilation (aOR 6.15, 95% CI 3.09-12.27). Compared to natalizumab, ocrelizumab and rituximab were associated with hospitalization (aOR 1.86, 95% CI 1.13-3.07; aOR 2.88, 95% CI 1.68-4.92) and ICU admission (aOR 2.13, 95% CI 0.85-5.35; aOR 3.23, 95% CI 1.17-8.91), but only rituximab was associated with ventilation (aOR 5.52, 95% CI 1.71-17.84). Associations persisted on restriction to confirmed COVID-19 cases. No associations were observed between DMTs and death. Stratification by age, MS phenotype, and EDSS score found no indications that DMT associations with COVID-19 severity reflected differential DMT allocation by underlying COVID-19 severity., Discussion: Using the largest cohort of people with MS and COVID-19 available, we demonstrated consistent associations of rituximab with increased risk of hospitalization, ICU admission, and need for artificial ventilation and of ocrelizumab with hospitalization and ICU admission. Despite the cross-sectional design of the study, the internal and external consistency of these results with prior studies suggests that rituximab/ocrelizumab use may be a risk factor for more severe COVID-19., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.)

Published
2021
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4. Longitudinal machine learning modeling of MS patient trajectories improves predictions of disability progression.

Author

De Brouwer E, Becker T, Moreau Y, Havrdova EK, Trojano M, Eichau S, Ozakbas S, Onofrj M, Grammond P, Kuhle J, Kappos L, Sola P, Cartechini E, Lechner-Scott J, Alroughani R, Gerlach O, Kalincik T, Granella F, Grand'Maison F, Bergamaschi R, José Sá M, Van Wijmeersch B, Soysal A, Sanchez-Menoyo JL, Solaro C, Boz C, Iuliano G, Buzzard K, Aguera-Morales E, Terzi M, Trivio TC, Spitaleri D, Van Pesch V, Shaygannejad V, Moore F, Oreja-Guevara C, Maimone D, Gouider R, Csepany T, Ramo-Tello C, and Peeters L

Subjects
Humans, Neural Networks, Computer, Machine Learning, Multiple Sclerosis
Abstract

Background and Objectives: Research in Multiple Sclerosis (MS) has recently focused on extracting knowledge from real-world clinical data sources. This type of data is more abundant than data produced during clinical trials and potentially more informative about real-world clinical practice. However, this comes at the cost of less curated and controlled data sets. In this work we aim to predict disability progression by optimally extracting information from longitudinal patient data in the real-world setting, with a special focus on the sporadic sampling problem., Methods: We use machine learning methods suited for patient trajectories modeling, such as recurrent neural networks and tensor factorization. A subset of 6682 patients from the MSBase registry is used., Results: We can predict disability progression of patients in a two-year horizon with an ROC-AUC of 0.85, which represents a 32% decrease in the ranking pair error (1-AUC) compared to reference methods using static clinical features., Conclusions: Compared to the models available in the literature, this work uses the most complete patient history for MS disease progression prediction and represents a step forward towards AI-assisted precision medicine in MS., Competing Interests: Declaration of Competing Interest The authors declare the following conflicts of interest., (Copyright © 2021. Published by Elsevier B.V.)

Published
2021
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5. Multiple Sclerosis Data Alliance - A global multi-stakeholder collaboration to scale-up real world data research.

Author

Peeters LM, Parciak T, Kalra D, Moreau Y, Kasilingam E, van Galen P, Thalheim C, Uitdehaag B, Vermersch P, Hellings N, Stinissen P, Van Wijmeersch B, Ardeshirdavani A, Pirmani A, De Brouwer E, Bauer CR, Krefting D, Ribbe S, Middleton R, Stahmann A, and Comi G

Subjects
Ecosystem, Humans, Research Design, Multiple Sclerosis epidemiology, Multiple Sclerosis therapy
Abstract

The Multiple Sclerosis Data Alliance (MSDA), a global multi-stakeholder collaboration, is working to accelerate research insights for innovative care and treatment for people with multiple sclerosis (MS) through better use of real-world data (RWD). Despite the increasing reliance on RWD, challenges and limitations complicate the generation, collection, and use of these data. MSDA aims to tackle sociological and technical challenges arising with scaling up RWD, specifically focused on MS data. MSDA envisions a patient-centred data ecosystem in which all stakeholders contribute and use big data to co-create the innovations needed to advance timely treatment and care of people with MS., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

Published
2021
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6. COVID-19 in people with multiple sclerosis: A global data sharing initiative.

Author

Peeters LM, Parciak T, Walton C, Geys L, Moreau Y, De Brouwer E, Raimondi D, Pirmani A, Kalincik T, Edan G, Simpson-Yap S, De Raedt L, Dauxais Y, Gautrais C, Rodrigues PR, McKenna L, Lazovski N, Hillert J, Forsberg L, Spelman T, McBurney R, Schmidt H, Bergmann A, Braune S, Stahmann A, Middleton R, Salter A, Bebo BF, Rojas JI, van der Walt A, Butzkueven H, van der Mei I, Ivanov R, Hellwig K, Sciascia do Olival G, Cohen JA, Van Hecke W, Dobson R, Magyari M, Brum DG, Alonso R, Nicholas R, Bauer J, Chertcoff A, de Sèze J, Louapre C, Comi G, and Rijke N

Subjects
Betacoronavirus, COVID-19, Coronavirus Infections complications, Coronavirus Infections therapy, Data Collection, Humans, Information Dissemination, International Cooperation, Multiple Sclerosis complications, Pandemics, Pneumonia, Viral complications, Pneumonia, Viral therapy, Risk Factors, SARS-CoV-2, Treatment Outcome, Coronavirus Infections physiopathology, Multiple Sclerosis therapy, Pneumonia, Viral physiopathology, Registries
Abstract

Background: We need high-quality data to assess the determinants for COVID-19 severity in people with MS (PwMS). Several studies have recently emerged but there is great benefit in aligning data collection efforts at a global scale., Objectives: Our mission is to scale-up COVID-19 data collection efforts and provide the MS community with data-driven insights as soon as possible., Methods: Numerous stakeholders were brought together. Small dedicated interdisciplinary task forces were created to speed-up the formulation of the study design and work plan. First step was to agree upon a COVID-19 MS core data set. Second, we worked on providing a user-friendly and rapid pipeline to share COVID-19 data at a global scale., Results: The COVID-19 MS core data set was agreed within 48 hours. To date, 23 data collection partners are involved and the first data imports have been performed successfully. Data processing and analysis is an on-going process., Conclusions: We reached a consensus on a core data set and established data sharing processes with multiple partners to address an urgent need for information to guide clinical practice. First results show that partners are motivated to share data to attain the ultimate joint goal: better understand the effect of COVID-19 in PwMS.

Published
2020
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7. Associations of Disease-Modifying Therapies With COVID-19 Severity in Multiple Sclerosis

Author

Georgina Arrambide, Ingrid van der Mei, Raed Alroughani, Lars Forsberg, Rodden M. Middleton, Guilherme Sciascia do Olival, Nikola Lazovski, Rumen Ivanov, Alexander Stahmann, Tomas Kalincik, Helmut Butzkueven, Richard S. Nicholas, J. Hillert, Alice Estavo Dias, Edward De Brouwer, Amber Salter, Serkan Ozakbas, Nupur Nag, Doralina Guimarães Brum, Alexander Fidao, Anna Zabalza, Yves Moreau, Ricardo Alonso, Anneke Van Der Walt, Nick Rijke, Lotte Geys, Anibal Chertcoff, Arnfin Bergmann, Robert N. McBurney, Clare Walton, Anna Glaser, Tina Parciak, Gilles Edan, Clément Gautrais, Ashkan Pirmani, Maria Fernanda Mendes, Juan Ignacio Rojas, Melinda Magyari, Liesbet M. Peeters, Robert J. Fox, Hollie Schmidt, Amin Ardeshirdavanai, Steve Simpson-Yap, Stefan Braune, Giancarlo Comi, Johana Bauer, Tim Spelman, Zabalza, Ana/0000-0003-3860-5251, Simpson, Jr., Steve/0000-0001-6521-3056, Kalincik, Tomas/0000-0003-3778-1376, Simpson-Yap, Steve, DE BROUWER, Edward, Kalincik, Tomas, Rijke, Nick, Hillert, Jan A., Walton, Clare, Edan, Gilles, Moreau, Yves, Spelman, Tim, GEYS, Lotte, PARCIAK, Tina, Gautrais, Clement, Lazovski, Nikola, PIRMANI, Ashkan, Ardeshirdavanai, Amin, Forsberg, Lars, Glaser, Anna, McBurney, Robert, Schmidt, Hollie, Bergmann, Arnfin B., Braune, Stefan, Stahmann, Alexander, Middleton, Rodden, Salter, Amber, Fox, Robert J., van der Walt, Anneke, Butzkueven, Helmut, Alroughani, Raed, Ozakbas, Serkan, Rojas, Juan, I, van der Mei, Ingrid, Nag, Nupur, Ivanov, Rumen, do Olival, Guilherme Sciascia, Dias, Alice Estavo, Magyari, Melinda, Brum, Doralina, Mendes, Maria Fernanda, Alonso, Ricardo N., Nicholas, Richard S., Bauer, Johana, Chertcoff, Anibal Sebastian, Zabalza, Anna, Arrambide, Georgina, Fidao, Alexander, Comi, Giancarlo, PEETERS, Liesbet, Institut Català de la Salut, [Simpson-Yap S] Department of Medicine, and Neuroepidemiology Unit, Melbourne School of Population & Global Health, University of Melbourne, Parkville, Australia. Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia [De Brouwer E] University of Tasmania, Hobart, Australia. ESAT-STADIUS, KU Leuven, Belgium. [Kalincik T] Department of Neurology, Melbourne MS Centre, Royal Melbourne Hospital, Parkville, Australia. [Rijke N, Walton C] MS International Federation, London, UK. [Hillert JA] Department of Clinical Neuroscience, Swedish MS Registry, Stockholm, Sweden. [Zabalza A, Arrambide G] Servei de Neurologia-Neuroimmunologia, Centre d'Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain, Vall d'Hebron Barcelona Hospital Campus, and Neuroepidemiology Unit, Melbourne School of Population and Global Health, University of Tasmania, KU Leuven, Royal Melbourne Hospital, MS International Federation, Swedish MS Registry, CHU Pontchaillou, Karolinska Institutet, Hasselt University, University Medical Center, QMENTA, Molecular Unit, Accelerated Cure Project for MS, NeuroTransData, MS Forschungs- und Projektentwicklungs-gGmbH, Swansea University, COViMS, Washington University in St. Louis, Cleveland Clinic, Monash University, Kuwait City, Dokuz Eylul University, Hospital Universitario de CEMIC, RELACOEM, Bulgarian SmartMS COVID-19 Dataset, ABEM-Brazilian MS Patients Association, University Hospital Rigshospitalet, Universidade Estadual Paulista (UNESP), REDONE.br-Brazilian Registry of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders, Irmandade da Santa Casa de Misericórdia de São Paulo, Ramos Mejia Hospital-EMA, Imperial College, Mental Health Area, EMA, Cemcat, Vall d'Hebron Hospital Universitari, Universitat Autònoma de Barcelona, and Ospedale San Raffaele

Subjects
Male, Dimethyl Fumarate, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Otros calificadores::Otros calificadores::/complicaciones [Otros calificadores], chemistry.chemical_compound, 0302 clinical medicine, Natalizumab, virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Medicine, 10. No inequality, COVID-19 (Malaltia) - Complicacions, B-Lymphocytes, Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis [DISEASES], Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], Middle Aged, 3. Good health, Hospitalization, enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple [ENFERMEDADES], Cohort, Female, Rituximab, Life Sciences & Biomedicine, Research Article, medicine.drug, Adult, medicine.medical_specialty, Multiple Sclerosis, Adolescent, Clinical Neurology, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Antibodies, Monoclonal, Humanized, Young Adult, 03 medical and health sciences, Internal medicine, Humans, Risk factor, Aged, 030203 arthritis & rheumatology, Science & Technology, Expanded Disability Status Scale, SARS-CoV-2, business.industry, COVID-19, Odds ratio, Respiration, Artificial, Cross-Sectional Studies, Siponimod, chemistry, Ocrelizumab, Neurosciences & Neurology, Neurology (clinical), business, Esclerosi múltiple - Tractament, 030217 neurology & neurosurgery, Other subheadings::Other subheadings::/complications [Other subheadings]
Abstract

Made available in DSpace on 2022-04-28T19:46:29Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-11-09 Background and ObjectivesPeople with multiple sclerosis MS are a vulnerable group for severe coronavirus disease 2019 COVID-19, particularly those taking immunosuppressive disease-modifying therapies DMTs. We examined the characteristics of COVID-19 severity in an international sample of people with MS.MethodsData from 12 data sources in 28 countries were aggregated sources could include patients from 1-12 countries. Demographic age, sex, clinical MS phenotype, disability, and DMT untreated, alemtuzumab, cladribine, dimethyl fumarate, glatiramer acetate, interferon, natalizumab, ocrelizumab, rituximab, siponimod, other DMTs covariates were queried, along with COVID-19 severity outcomes, hospitalization, intensive care unit ICU admission, need for artificial ventilation, and death. Characteristics of outcomes were assessed in patients with suspected/confirmed COVID-19 using multilevel mixed-effects logistic regression adjusted for age, sex, MS phenotype, and Expanded Disability Status Scale EDSS score.ResultsSix hundred fifty-seven 28.1% with suspected and 1,683 61.9% with confirmed COVID-19 were analyzed. Among suspected plus confirmed and confirmed-only COVID-19, 20.9% and 26.9% were hospitalized, 5.4% and 7.2% were admitted to ICU, 4.1% and 5.4% required artificial ventilation, and 3.2% and 3.9% died. Older age, progressive MS phenotype, and higher disability were associated with worse COVID-19 outcomes. Compared to dimethyl fumarate, ocrelizumab and rituximab were associated with hospitalization adjusted odds ratio [aOR] 1.56, 95% confidence interval [CI] 1.01-2.41; aOR 2.43, 95% CI 1.48-4.02 and ICU admission aOR 2.30, 95% CI 0.98-5.39; aOR 3.93, 95% CI 1.56-9.89, although only rituximab was associated with higher risk of artificial ventilation aOR 4.00, 95% CI 1.54-10.39. Compared to pooled other DMTs, ocrelizumab and rituximab were associated with hospitalization aOR 1.75, 95% CI 1.29-2.38; aOR 2.76, 95% CI 1.87-4.07 and ICU admission aOR 2.55, 95% CI 1.49-4.36; aOR 4.32, 95% CI 2.27-8.23, but only rituximab was associated with artificial ventilation aOR 6.15, 95% CI 3.09-12.27. Compared to natalizumab, ocrelizumab and rituximab were associated with hospitalization aOR 1.86, 95% CI 1.13-3.07; aOR 2.88, 95% CI 1.68-4.92 and ICU admission aOR 2.13, 95% CI 0.85-5.35; aOR 3.23, 95% CI 1.17-8.91, but only rituximab was associated with ventilation aOR 5.52, 95% CI 1.71-17.84. Associations persisted on restriction to confirmed COVID-19 cases. No associations were observed between DMTs and death. Stratification by age, MS phenotype, and EDSS score found no indications that DMT associations with COVID-19 severity reflected differential DMT allocation by underlying COVID-19 severity.DiscussionUsing the largest cohort of people with MS and COVID-19 available, we demonstrated consistent associations of rituximab with increased risk of hospitalization, ICU admission, and need for artificial ventilation and of ocrelizumab with hospitalization and ICU admission. Despite the cross-sectional design of the study, the internal and external consistency of these results with prior studies suggests that rituximab/ocrelizumab use may be a risk factor for more severe COVID-19. CORe Department of Medicine and Neuroepidemiology Unit Melbourne School of Population and Global Health Menzies Institute for Medical Research University of Tasmania ESAT-STADIUS KU Leuven Department of Neurology Melbourne MS Centre Royal Melbourne Hospital MS International Federation Department of Clinical Neuroscience Swedish MS Registry Department of Neurology CHU Pontchaillou Karolinska Institutet Biomedical Research Institute-Data Science Institute Hasselt University Department of Medical Informatics University Medical Center Department of Computer Science and AI KU Leuven QMENTA Medpace Reference Laboratories Molecular Unit IConquerMS People-Powered Research Network Accelerated Cure Project for MS NeuroTransData Study Group NeuroTransData German MS-Register by the National MS Society MS Forschungs- und Projektentwicklungs-gGmbH MS Register Swansea University COViMS Division of Biostatistics Washington University in St. Louis Mellen Center for Multiple Sclerosis Cleveland Clinic Department of Neuroscience Central Clinical School Monash University Al-Amiri Hospital Kuwait City Dokuz Eylul University Neurology Department Hospital Universitario de CEMIC RELACOEM Australian MS Longitudinal Study Menzies Institute for Medical Research University of Tasmania Bulgarian SmartMS COVID-19 Dataset ABEM-Brazilian MS Patients Association Danish Multiple Sclerosis Registry Department of Neurology University Hospital Rigshospitalet Universidade Estadual Paulista Unesp Faculdade de Medicina REDONE.br-Brazilian Registry of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders Irmandade da Santa Casa de Misericórdia de São Paulo Multiple Sclerosis University Center Ramos Mejia Hospital-EMA Imperial College Swansea University Mental Health Area MS and Demyelinating Diseases Hospital Británico de Buenos Aires EMA Servei de Neurologia-Neuroimmunologia Centre d'Esclerosi Múltiple de Catalunya Cemcat Vall d'Hebron Institut de Recerca Vall d'Hebron Hospital Universitari Universitat Autònoma de Barcelona Institute of Experimental Neurology Ospedale San Raffaele Universidade Estadual Paulista Unesp Faculdade de Medicina

Published
2021
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