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Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies: results from the COVAD study

Doskaliuk B 1 , Ravichandran N 2 , Sen P 3 , Day J 4 , Joshi M 5 , Nune A 6 Show all authors , Nikiphorou E 7 , Saha S 8 , Tan AL 9 , Shinjo SK 10 , Ziade N 11 , Velikova T 12 , Milchert M 13 , Jagtap K 14 , Parodis I 15 , Gracia-Ramos AE 16 , Cavagna L 17 , Kuwana M 18 , Knitza J 19 , Chen YM 20 , Makol A 21 , Agarwal V 22 , Patel A 23 , Pauling JD 24 , Wincup C 25 , Barman B 26 , Tehozol EAZ 27 , Serrano JR 28 , La Torre IG 29 , Colunga-Pedraza IJ 30 , Merayo-Chalico J 31 , Chibuzo OC 32 , Katchamart W 33 , Goo PA 34 , Shumnalieva R 35 , Hoff LS 36 , Kibbi LE 37 , Halabi H 38 , Vaidya B 39 , Shaharir SS 40 , Hasan ATMT 41 , Dey D 42 , Gutiérrez CET 43 , Caballero-Uribe CV 44 , Lilleker JB 45 , Salim B 46 , Gheita T 47 , Chatterjee T 48 , Distler O 49 , Saavedra MA 50 , COVAD study group , Chinoy H 45 , Agarwal V 2 , Aggarwal R 51 , Gupta L 52

Affiliations 

  • 1 Department of Pathophysiology, Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine
  • 2 Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
  • 3 Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi, 110002, India
  • 4 Department of Rheumatology, Royal Melbourne Hospital, Parkville, VIC, 3050, Australia
  • 5 Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India
  • 6 Southport and Ormskirk Hospital NHS Trust, Southport, PR8 6PN, UK
  • 7 Centre for Rheumatic Diseases, King's College London, London, UK
  • 8 Mymensingh Medical College, Mymensingh, Bangladesh
  • 9 NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK
  • 10 Division of RheumatologyFaculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil
  • 11 Rheumatology Department, Saint-Joseph University, Beirut, Lebanon
  • 12 Medical Faculty, Sofia University St. Kliment Ohridski, 1 Kozyak Str, 1407, Sofia, Bulgaria
  • 13 Department of Internal Medicine, Rheumatology, Diabetology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, Ul Unii Lubelskiej 1, 71-252, Szczecin, Poland
  • 14 Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital, Mumbai, Maharashtra, India
  • 15 Division of RheumatologyDepartment of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden
  • 16 Department of Internal Medicine, General Hospital, National Medical Center "La Raza", Instituto Mexicano del Seguro Social, Av. Jacaranda S/N, Col. La Raza, Del. Azcapotzalco, C.P. 02990, Mexico City, Mexico
  • 17 Rheumatology UnitDipartimento Di Medicine Interna E Terapia Medica, Università Degli Studi Di Pavia, Pavia, Lombardy, Italy
  • 18 Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, 1-1-5 Sendagi, Bunkyo-Ku, Tokyo, 113-8602, Japan
  • 19 Medizinische Klinik 3-Rheumatologie und Immunologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Ulmenweg 18, 91054, Erlangen, Deutschland
  • 20 Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung City, Taiwan
  • 21 Division of Rheumatology, Mayo Clinic, Rochester, MN, USA
  • 22 Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India
  • 23 Bon Secours Rheumatology Center and Division of Pediatric RheumatologyDepartment of Pediatrics, University of Virginia School of Medicine, Charlottesville, VA, USA
  • 24 Bristol Medical School Translational Health Sciences, University of Bristol, Bristol, UK
  • 25 Division of Medicine, Rayne InstituteDepartment of Rheumatology, University College London, London, UK
  • 26 Department of General Medicine, All India Institute of Medical Sciences (AIIMS), Guwahati, India
  • 27 Rheumatology, Medical Care & Research, Centro Medico Pensiones Hospital, Instituto Mexicano del Seguro Social Delegación Yucatán, Yucatán, Mexico
  • 28 Rheumatologist and Clinical InvestigatorInterstitial Lung Disease and Rheumatology Unit, Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico
  • 29 Departamento de Inmunología Y Reumatología, Hospital General de Occidente and Universidad de Guadalajara, Guadalajara, Jalisco, Mexico
  • 30 Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey, Mexico
  • 31 Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Mexico City, Mexico
  • 32 Department of Medicine, University of Nigeria Teaching Hospital, Ituku-Ozalla/University of Nigeria, Enugu Campus, Enugu, Nigeria
  • 33 Division of RheumatologyDepartment of MedicineFaculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
  • 34 Department of Medicine, Queen Savang Vadhana Memorial Hospital, Chonburi, Thailand
  • 35 Department of RheumatologyClinic of Rheumatology, University Hospital "St. Ivan Rilski", Medical University-Sofia, Sofia, Bulgaria
  • 36 School of Medicine, Universidade Potiguar (UnP), Natal, Brazil
  • 37 Internal Medicine Department, Rheumatology Unit, Specialized Medical Center, Riyadh, Saudi Arabia
  • 38 Department of Internal MedicineSection of Rheumatology, King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia
  • 39 National Center for Rheumatic Diseases (NCRD), Ratopul, Kathmandu, Nepal
  • 40 Faculty of Medicine, Universiti Kebangsaan Malaysia, 56000, Cheras, Kuala Lumpur, Malaysia
  • 41 Department of Rheumatology, Enam Medical College & Hospital, Dhaka, Bangladesh
  • 42 Department of Medicine and Therapeutics, Rheumatology Unit, University of Ghana Medical SchoolCollege of Health Sciences, Korle-Bu, Accra, Ghana
  • 43 Reference Center for Osteoporosis, Rheumatology and Dermatology, Pontifica Universidad Javeriana Cali, Cali, Colombia
  • 44 Department of Medicine, Hospital Universidad del Norte, Barranquilla, Atlantico, Colombia
  • 45 Division of Musculoskeletal and Dermatological Sciences, Centre for Musculoskeletal Research, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK
  • 46 Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan
  • 47 Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt
  • 48 Department of Internal Medicine, University of Illinois College of Medicine at Peoria, Peoria, IL, USA
  • 49 Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland
  • 50 Departamento de Reumatología Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico
  • 51 Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
  • 52 Division of Musculoskeletal and Dermatological Sciences, Centre for Musculoskeletal Research, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK. drlatikagupta@gmail.com
Rheumatol Int, 2023 Sep;43(9):1651-1664.
PMID: 37351634 DOI: 10.1007/s00296-023-05345-y

Abstract

Limited evidence on long-term COVID-19 vaccine safety in patients with idiopathic inflammatory myopathies (IIMs) continues to contribute to vaccine hesitancy. We studied delayed-onset vaccine adverse events (AEs) in patients with IIMs, other systemic autoimmune and inflammatory disorders (SAIDs), and healthy controls (HCs), using data from the second COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. A validated self-reporting e-survey was circulated by the COVAD study group (157 collaborators, 106 countries) from Feb-June 2022. We collected data on demographics, comorbidities, IIM/SAID details, COVID-19 history, and vaccination details. Delayed-onset (> 7 day) AEs were analyzed using regression models. A total of 15165 respondents undertook the survey, of whom 8759 responses from vaccinated individuals [median age 46 (35-58) years, 74.4% females, 45.4% Caucasians] were analyzed. Of these, 1390 (15.9%) had IIMs, 50.6% other SAIDs, and 33.5% HCs. Among IIMs, 16.3% and 10.2% patients reported minor and major AEs, respectively, and 0.72% (n = 10) required hospitalization. Notably patients with IIMs experienced fewer minor AEs than other SAIDs, though rashes were expectedly more than HCs [OR 4.0; 95% CI 2.2-7.0, p 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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