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COVID-19 SEVERITY A...
COVID-19 SEVERITY AND VACCINE BREAKTHROUGH INFECTIONS IN IDIOPATHIC INFLAMMATORY MYOPATHIES, OTHER SYSTEMIC AUTOIMMUNE AND INFLAMMATORY DISEASES, AND HEALTHY INDIVIDUALS : RESULTS FROM THE COVID-19 VACCINATION IN AUTOIMMUNE DISEASES (COVAD) STUDY.
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- Gupta, L. (author)
- Royal Wolverhampton Hospitals NHS Trust, Department of Rheumatology, Wolverhampton, United Kingdom; Sanjay Gandhi Postgraduate Institute of Medical Sciences, Department of Clinical Immunology and Rheumatology, Lucknow, India
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- Hoff, L. S. (author)
- Universidade de Sao Paulo Faculdade de Medicina FMUSP, Division of Rheumatology, Sao Paulo, Brazil
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- R, N. (author)
- Sanjay Gandhi Postgraduate Institute of Medical Sciences, Department of Clinical Immunology and Rheumatology, Lucknow, India
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- Sen, P. (author)
- Maulana Azad Medical College, Undergraduate, New Delhi, India
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- Katsuyuki Shinjo, S. (author)
- Universidade de Sao Paulo Faculdade de Medicina FMUSP, Division of Rheumatology, Sao Paulo, Brazil
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- Day, J. (author)
- Royal Melbourne Hospital, Department of Rheumatology, Parkville, Australia; Walter and Eliza Hall Institute of Medical Research, Parkville, Australia; University of Melbourne, Department of Medical Biology, Parkville, Australia
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- Lilleker, J. B. (author)
- School of Biological Sciences, The University of Manchester, Division of Musculoskeletal and Dermatological Sciences, Manchester, United Kingdom; Manchester Centre for Clinical Neurosciences, Neurology, Salford, United Kingdom
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- Agarwal, V. (author)
- Mahatma Gandhi Mission Medical College, Navi Mumbai, India
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- Kardes, S. (author)
- Istanbul University Faculty of Medicine, Department of Medical Ecology and Hydroclimatology, Istanbul, Turkey
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- Kim, M. (author)
- University of Illinois College of Medicine at Peoria, Department of Internal Medicine, Peoria, United States of America
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- Makol, A. (author)
- Mayo Clinic, Division of Rheumatology, Rochester, United States of America
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- Milchert, M. (author)
- Pomeranian Medical University in Szczecin, Department of Internal Medicine, Rheumatology, Geriatrics and Clinical Immunology, Szczecin, Poland
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- Gheita, T. A. (author)
- Kasr Al Ainy School of Medicine, Cairo University, Department of Rheumatology, Cairo, Egypt
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- Salim, B. (author)
- Fauji Foundation Hospital, Department of Clinical Immunology, Rawalpindi, Pakistan
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- Velikova, T. (author)
- University Hospital “Lozenetz”, Sofia University, Department of Clinical Immunology, Sofia, Bulgaria
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- Gracia-Ramos, A. E. (author)
- General Hospital, National Medical Center “La Raza”, Instituto Mexicano del Seguro Social, Department of Internal Medicine, Mexico City, Mexico
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- Parodis, Ioannis, 1981- (author)
- Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Stockholm, Sweden; Örebro University Faculty of Medicine and Health, Department of Rheumatology, Örebro, Sweden
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- Selva-O'callaghan, A. (author)
- Vall D’hebron General Hospital, Universitat Autonoma de Barcelona, Department of Internal Medicine, Barcelona, Spain
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- Nikiphorou, E. (author)
- King’s College London, Centre for Rheumatic Diseases, London, United Kingdom; King’s College Hospital, Department of Rheumatology, London, United Kingdom
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- Chatterjee, T. (author)
- University of Illinois College of Medicine at Peoria, Department of Internal Medicine, Peoria, United States of America
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- Tan, A. L. (author)
- Leeds Teaching Hospitals Trust, NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom; University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom
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- Nune, A. (author)
- Southport and Ormskirk Hospital NHS Trust, Southport, United Kingdom
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- Cavagna, L. (author)
- Fondazione I.R.C.C.S. Policlinico San Matteo, Division of Rheumatology, Pavia, Italy; University of Pavia, Department of Internal Medicine and Medical Therapeutics, Pavia, Italy
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- Saavedra, M. A. (author)
- Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, IMSS, Department of Rheumatology, Mexico City, Mexico
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- Ziade, N. (author)
- Saint-Joseph University, Department of Rheumatology, Beirut, Lebanon; Hotel-Dieu de France Hospital, Department of Rheumatology, Beirut, Lebanon
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- Knitza, J. (author)
- Friedrich-Alexander-Universität Erlangen-Nürnberg, Department of Rheumatology and Immunology, Erlangen, Germany
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- Kuwana, M. (author)
- Nippon Medical School Graduate School of Medicine, Department of Allergy and Rheumatology, Tokyo, Japan
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- Distler, O. (author)
- University Hospital Zurich, University of Zurich, Department of Rheumatology, Zurich, Switzerland
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- Chinoy, H. (author)
- School of Biological Sciences, The University of Manchester, Division of Musculoskeletal and Dermatological Sciences, Manchester, United Kingdom; The University of Manchester, National Institute for Health Research Manchester Biomedical Research Centre, Manchester, United Kingdom; Manchester Academic Health Science Centre, Department of Rheumatology, Salford, United Kingdom
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- Agarwal, V. (author)
- Sanjay Gandhi Postgraduate Institute of Medical Sciences, Department of Clinical Immunology and Rheumatology, Lucknow, India
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- Aggarwal, R. (author)
- University of Pittsburgh School of Medicine, Division of Rheumatology and Clinical Immunology, Pittsburgh, United States of America
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(creator_code:org_t)
- 2022-05-23
- 2022
- English.
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In: Annals of the Rheumatic Diseases. - : HighWire Press. - 0003-4967 .- 1468-2060. ; 81:Suppl. 1, s. 334-336
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Abstract
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- Significant gaps are present in the evidence of the spectrum and severity of COVID-19 infection in idiopathic inflammatory myopathies (IIM). IIM patients typically require immunosuppressive therapy, may have multiple disease sequelae, and frequent comorbidities, and thus may be more susceptible to severe COVID-19 infection and complications (1). The possibility of attenuated immunogenicity and reduced efficacy of COVID-19 vaccines due to concomitant immunosuppressive medication is a major concern in these patients, and there is little data available on COVID-19 vaccine breakthrough infections (BI) in IIM (2).ObjectivesThis study aimed to compare disease spectrum and severity and COVID-19 BI in patients with IIM, other systemic autoimmune and inflammatory diseases (SAIDs) and healthy controls (HCs).MethodsWe developed an extensive self-reporting electronic-survey (COVAD survey) featuring 36 questions to collect respondent demographics, SAID details, COVID-19 infection history, COVID-19 vaccination details, 7-day post vaccination adverse events and patient reported outcome measures using the PROMIS tool. After pilot testing, validation, translation into 18 languages on the online platform surveymonkey.com, and vetting by international experts, the COVAD survey was circulated in early 2021 by a multicenter study group of >110 collaborators in 94 countries. BI was defined as COVID-19 infection occurring more than 2 weeks after receiving 1st or 2nd dose of a COVID-19 vaccine. We analyzed data from the baseline survey for descriptive and intergroup comparative statistics based on data distribution and variable type.Results10900 respondents [mean age 42 (30-55) years, 74% females and 45% Caucasians] were analyzed. 1,227 (11.2%) had IIM, 4,640 (42.6%) had other SAIDs, and 5,033 (46.2%) were HC. All respondents included in the final analysis had received a single dose of the vaccine and 69% had received 2 primary doses. Pfizer (39.8%) was the most common vaccine received, followed by Oxford/AstraZeneca (13.4%), and Covishield (10.9%). IIM patients were older, had a higher Caucasian representation and higher Pfizer uptake than other SAIDs, and HC. A higher proportion of IIM patients received immunosuppressants than other SAIDs.IIMs were at a lower risk of symptomatic pre-vaccination COVID-19 infection compared to SAIDs [multivariate OR 0.6 (0.4-0.8)] and HCs [multivariate OR 0.39 (0.28-0.54)], yet at a higher risk of hospitalization due to COVID-19 compared to SAIDs [univariate OR 2.3 (1.2-3.5)] and HCs [multivariate OR 2.5 (1.1-5.8)]. BIs were very uncommon in IIM patients, with only 17 (1.4%) reporting BI. IIM patients were at a higher risk of contracting COVID-19 prior to vaccination than ≤2 weeks of vaccination [univariate OR 8 (4.1-15)] or BI [univariate OR 4.6 (2.7-8.0)]. BIs were equally severe compared to when they occurred prior to vaccination in IIMs, and were comparable between IIM, SAIDs, and HC (Figure 1), though BI disease duration was shorter in IIMs than SAIDs (7 vs 11 days, p 0.027). 13/17 IIM patients with BI were on immunosuppressants.ConclusionIIM patients experienced COVID-19 infection less frequently prior to vaccination but were at a higher risk of hospitalization and requirement for oxygen therapy compared with patients with HC. Breakthrough COVID-19 infections were rare (1.4%) in vaccinated IIM patients, and were similar to HC and SAIDs, except for shorter disease duration in IIM.References[1]Brito-Zerón P, Sisó-Almirall A, Flores-Chavez A, Retamozo S, Ramos-Casals M. SARS-CoV-2 infection in patients with systemic autoimmune diseases. Clin Exp Rheumatol. 2021 Jun;39(3):676–87.[2]Wack S, Patton T, Ferris LK. COVID-19 vaccine safety and efficacy in patients with immune-mediated inflammatory disease: Review of available evidence. J Am Acad Dermatol. 2021 Nov;85(5):1274–84.AcknowledgementsThe authors thank all members of the COVAD study group for their invaluable role in the collection of data. The authors thank all respondents for filling the questionnaire. The authors thank The Myositis Association, Myositis India, Myositis UK, the Myositis Global Network, Cure JM, Cure IBM, Sjögren’s India Foundation, EULAR PARE, and various other patient support groups and organizations for their invaluable contribution in the dissemination of this survey among patients which made the data collection possible. The authors also thank all members of the COVAD study group.Disclosure of InterestsLatika Gupta: None declared, Leonardo Santos Hoff: None declared, Naveen R: None declared, Parikshit Sen: None declared, Samuel Katsuyuki Shinjo: None declared, Jessica Day Grant/research support from: JD has received research funding from CSL Limited, James B. Lilleker: None declared, Vishwesh Agarwal: None declared, Sinan Kardes: None declared, Minchul Kim: None declared, Ashima Makol: None declared, Marcin Milchert: None declared, Tamer A Gheita: None declared, Babur Salim: None declared, Tsvetelina Velikova: None declared, Abraham Edgar Gracia-Ramos: None declared, Ioannis Parodis Speakers bureau: IP has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia Pharmaceuticals, Elli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis and F. Hoffmann-La Roche AG., Consultant of: IP has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia Pharmaceuticals, Elli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis and F. Hoffmann-La Roche AG., Grant/research support from: IP has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia Pharmaceuticals, Elli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis and F. Hoffmann-La Roche AG., Albert Selva-O’Callaghan: None declared, Elena Nikiphorou Speakers bureau: EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Lilly, Consultant of: EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Lilly, Grant/research support from: EN holds research grants from Pfizer and Lilly., Tulika Chatterjee: None declared, Ai Lyn Tan Speakers bureau: ALT has received honoraria for advisory boards and speaking for Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB., Consultant of: ALT has received honoraria for advisory boards and speaking for Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB., Arvind Nune: None declared, Lorenzo Cavagna: None declared, Miguel A Saavedra: None declared, Nelly Ziade Speakers bureau: NZ has received speaker fees, advisory board fees and research grants from Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, Pierre Fabre; none is related to this manuscript, Consultant of: NZ has received speaker fees, advisory board fees and research grants from Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, Pierre Fabre; none is related to this manuscript, Grant/research support from: NZ has received speaker fees, advisory board fees and research grants from Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, Pierre Fabre; none is related to this manuscript, Johannes Knitza: None declared, Masataka Kuwana: None declared, Oliver Distler Speakers bureau: OD has/had consultancy relationship with and/or has received research funding from or has served as a speaker for the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three years: Abbvie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, Baecon, Blade, Bayer, Boehringer Ingelheim, ChemomAb, Corbus, CSL Behring, Galapagos, Glenmark, GSK, Horizon (Curzion), Inventiva, iQvia, Kymera, Lupin, Medac, Medscape, Mitsubishi Tanabe, Novartis, Roche, Roivant, Sanofi, Serodapharm, Topadur and UCB. Patent issued “mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143)., Consultant of: OD has/had consultancy relationship with and/or has received research funding from or has served as a speaker for the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three years: Abbvie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, Baecon, Blade, Bayer, Boehringer Ingelheim, ChemomAb, Corbus, CSL Behring, Galapagos, Glenmark, GSK, Horizon (Curzion), Inventiva, iQvia, Kymera, Lupin, Medac, Medscape, Mitsubishi Tanabe, Novartis, Roche, Roivant, Sanofi, Serodapharm, Topadur and UCB. Patent issued “mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143)., Grant/research support from: OD has/had consultancy relationship with and/or has received research funding from or has served as a speaker for the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three years: Abbvie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, Baecon, Blade, Bayer, Boehringer Ingelheim, ChemomAb, Corbus, CSL Behring, Galapagos, Glenmark, GSK, Horizon (Curzion), Inventiva, iQvia, Kymera, Lupin, Medac, Medscape, Mitsubishi Tanabe, Novartis, Roche, Roivant, Sanofi, Serodapharm, Topadur and UCB. Patent issued “mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143)., Hector Chinoy Speakers bureau: HC has been a speaker for UCB, Biogen., Consultant of: HC has received consulting fees from Novartis, Eli Lilly, Orphazyme, Astra Zeneca, Grant/research support from: HC has received grant support from Eli Lilly and UCB, Vikas Agarwal: None declared, Rohit Aggarwal Consultant of: RA has/had a consultancy relationship with and/or has received research funding from the following companies-Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, and Abbvie, Janssen, Alexion, Argenx, Q32
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reumatologi och inflammation (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Rheumatology and Autoimmunity (hsv//eng)
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Gupta, L.
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Sen, P.
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Lilleker, J. B.
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Makol, A.
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Milchert, M.
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Gheita, T. A.
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Salim, B.
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Cavagna, L.
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Saavedra, M. A.
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Ziade, N.
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Knitza, J.
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Distler, O.
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