Albert Gil-Vila1, Naveen Ravichandran2, Albert Selva-O'Callaghan1, Parikshit Sen3, Arvind Nune4, Prithvi Sanjeevkumar Gaur5, Raquel Arànega Gonzalez6, James B Lilleker7,8, Mrudula Joshi9, Vishwesh Agarwal10, Sinan Kardes11, Minchul Kim12, Jessica Day13,14,15, Ashima Makol16, Marcin Milchert17, Tamer Gheita18, Babur Salim19, Tsvetelina Velikova20, Abraham Edgar Gracia-Ramos21, Ioannis Parodis22,23, Elena Nikiphorou24,25, Ai Lyn Tan26,27, Tulika Chatterjee12, Lorenzo Cavagna28,29, Miguel A Saavedra30, Samuel Katsuyuki Shinjo31, Nelly Ziade32,33, Johannes Knitza34, Masataka Kuwana35, Oliver Distler36, Hector Chinoy7,37,38, Vikas Agarwal2, Rohit Aggarwal39, Latika Gupta2,7,40,41. 1. Systemic Autoimmune Diseases Unit, Vall d'Hebron General Hospital, Medicine Department, Universitat Autónoma de Barcelona, Barcelona, Spain. 2. Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. 3. Maulana Azad Medical College, Delhi, India. 4. Southport and Ormskirk Hospital NHS Trust, Southport, UK. 5. Smt. Kashibai Navale Medical and General Hospital, Pune, India. 6. Internal Medicine Department, Hospital Clinic, Barcelona, Spain. 7. Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. 8. Neurology, Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Salford, UK. 9. Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India. 10. Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India. 11. Department of Medical Ecology and Hydroclimatology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey. 12. Center for Outcomes Research, Department of Internal Medicine, University of Illinois College of Medicine Peoria, Peoria, Illinois. 13. Department of Rheumatology, Royal Melbourne Hospital, Parkville, Victoria, Australia. 14. Walter and Eliza Hall Institute of Medical Research, Parkville, Victoria, Australia. 15. Department of Medical Biology, University of Melbourne, Parkville, Victoria, Australia. 16. Division of Rheumatology, Mayo Clinic, Rochester, Minnesota. 17. Department of Internal Medicine, Rheumatology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, Szczecin, Poland. 18. Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt. 19. Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan. 20. Department of Clinical Immunology, Medical Faculty, University Hospital "Lozenetz," Sofia University St. Kliment Ohridski, Sofia, Bulgaria. 21. Department of Internal Medicine, General Hospital, National Medical Center "La Raza," Instituto Mexicano del Seguro Social, Mexico City, Mexico. 22. Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden. 23. Department of Rheumatology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden. 24. Centre for Rheumatic Diseases, King's College London, London, UK. 25. Rheumatology Department, King's College Hospital, London, UK. 26. NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK. 27. Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK. 28. Department of Rheumatology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 29. Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Università degli studi di Pavia, Pavia, Lombardy, Italy. 30. Departamento de Reumatología Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico. 31. Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, Brazil. 32. Rheumatology Department, Saint-Joseph University, Beirut, Lebanon. 33. Rheumatology Department, Hotel-Dieu de France Hospital, Beirut, Lebanon. 34. Medizinische Klinik 3-Rheumatologie und Immunologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany. 35. Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan. 36. Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. 37. National Institute for Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, University of Manchester, Manchester, UK. 38. Department of Rheumatology, Salford Royal Hospital Northern Care Alliance NHS Foundation Trust, Salford, UK. 39. Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. 40. Department of Rheumatology, Royal Wolverhampton Hospital NHS Trust, Wolverhampton, UK. 41. City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK.
Abstract
INTRODUCTION/AIMS: In this study we investigated COVID-19 vaccination-related adverse events (ADEs) 7 days postvaccination in patients with idiopathic inflammatory myopathies (IIMs) and other systemic autoimmune and inflammatory disorders (SAIDs). METHODS: Seven-day vaccine ADEs were collected in an international patient self-reported e-survey. Descriptive statistics were obtained and multivariable regression was performed. RESULTS: Ten thousand nine hundred respondents were analyzed (1227 IIM cases, 4640 SAID cases, and 5033 healthy controls [HCs]; median age, 42 [interquartile range, 30-455] years; 74% female; 45% Caucasian; 69% completely vaccinated). Major ADEs were reported by 76.3% of the IIM patients and 4.6% reported major ADEs. Patients with active IIMs reported more frequent major (odds ratio [OR], 2.7; interquartile range [IQR], 1.04-7.3) and minor (OR, 1.5; IQR, 1.1-2.2) ADEs than patients with inactive IIMs. Rashes were more frequent in IIMs (OR, 2.3; IQR, 1.2-4.2) than HCs. ADEs were not impacted by steroid dose, although hydroxychloroquine and intravenous/subcutaneous immunoglobulins were associated with a higher risk of minor ADEs (OR, 1.9; IQR, 1.1-3.3; and OR, 2.2; IQR, 1.1-4.3, respectively). Overall, ADEs were less frequent in inclusion-body myositis (IBM) and BNT162b2 (Pfizer) vaccine recipients. DISCUSSION: Seven-day postvaccination ADEs were comparable in patients with IIMs, SAIDs, and HCs, except for a higher risk of rash in IIMs. Patients with dermatomyositis with active disease may be at higher risk, and IBM patients may be at lower risk of specific ADEs. Overall, the benefit of preventing severe COVID-19 through vaccination likely outweighs the risk of vaccine-related ADEs. Our results may inform future guidelines regarding COVID-19 vaccination in patients with SAIDs, specifically in those with IIMs. Studies to evaluate long-term outcomes and disease flares are needed to shed more light on developing future COVID-19 vaccination guidelines.
INTRODUCTION/AIMS: In this study we investigated COVID-19 vaccination-related adverse events (ADEs) 7 days postvaccination in patients with idiopathic inflammatory myopathies (IIMs) and other systemic autoimmune and inflammatory disorders (SAIDs). METHODS: Seven-day vaccine ADEs were collected in an international patient self-reported e-survey. Descriptive statistics were obtained and multivariable regression was performed. RESULTS: Ten thousand nine hundred respondents were analyzed (1227 IIM cases, 4640 SAID cases, and 5033 healthy controls [HCs]; median age, 42 [interquartile range, 30-455] years; 74% female; 45% Caucasian; 69% completely vaccinated). Major ADEs were reported by 76.3% of the IIM patients and 4.6% reported major ADEs. Patients with active IIMs reported more frequent major (odds ratio [OR], 2.7; interquartile range [IQR], 1.04-7.3) and minor (OR, 1.5; IQR, 1.1-2.2) ADEs than patients with inactive IIMs. Rashes were more frequent in IIMs (OR, 2.3; IQR, 1.2-4.2) than HCs. ADEs were not impacted by steroid dose, although hydroxychloroquine and intravenous/subcutaneous immunoglobulins were associated with a higher risk of minor ADEs (OR, 1.9; IQR, 1.1-3.3; and OR, 2.2; IQR, 1.1-4.3, respectively). Overall, ADEs were less frequent in inclusion-body myositis (IBM) and BNT162b2 (Pfizer) vaccine recipients. DISCUSSION: Seven-day postvaccination ADEs were comparable in patients with IIMs, SAIDs, and HCs, except for a higher risk of rash in IIMs. Patients with dermatomyositis with active disease may be at higher risk, and IBM patients may be at lower risk of specific ADEs. Overall, the benefit of preventing severe COVID-19 through vaccination likely outweighs the risk of vaccine-related ADEs. Our results may inform future guidelines regarding COVID-19 vaccination in patients with SAIDs, specifically in those with IIMs. Studies to evaluate long-term outcomes and disease flares are needed to shed more light on developing future COVID-19 vaccination guidelines.
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Authors: Sebastian Eduardo Sattui; Jean W Liew; Jonathan S Hausmann; Julia F Simard; Jeffrey A Sparks; Kevin Kennedy; Emily Sirotich; Michael Putman; Tarin T Moni; Akpabio Akpabio; Deshiré Alpízar-Rodríguez; Francis Berenbaum; Inita Bulina; Richard Conway; Aman Dev Singh; Eimear Duff; Karen L Durrant; Tamer A Gheita; Catherine L Hill; Richard A Howard; Bimba F Hoyer; Evelyn Hsieh; Lina El Kibbi; Adam Kilian; Alfred Hyoungju Kim; David F L Liew; Chieh Lo; Bruce Miller; Serena Mingolla; Michal Nudel; Candace A Palmerlee; Jasvinder A Singh; Namrata Singh; Manuel Francisco Ugarte-Gil; John Wallace; Kristen J Young; Suleman Bhana; Wendy Costello; Rebecca Grainger; Pedro M Machado; Philip C Robinson; Paul Sufka; Zachary S Wallace; Jinoos Yazdany; Carly Harrison; Maggie Larché; Mitchell Levine; Gary Foster; Lehana Thabane; Lisa G Rider Journal: RMD Open Date: 2021-09
Authors: Parikshit Sen; Latika Gupta; James B Lilleker; Vishwesh Aggarwal; Sinan Kardes; Marcin Milchert; Tamer Gheita; Babur Salim; Tsvetelina Velikova; Abraham Edgar Gracia-Ramos; Ioannis Parodis; Albert Selva O'Callaghan; Elena Nikiphorou; Ai Lyn Tan; Lorenzo Cavagna; Miguel A Saavedra; Samuel Katsuyuki Shinjo; Nelly Ziade; Johannes Knitza; Masataka Kuwana; Giovanni Cagnotto; Arvind Nune; Oliver Distler; Hector Chinoy; Vikas Aggarwal; Rohit Aggarwal Journal: Rheumatol Int Date: 2021-11-15 Impact factor: 2.631
Authors: Samuel K Shinjo; Fernando H C de Souza; Isabela B P Borges; Alexandre M Dos Santos; Renata Miossi; Rafael G Misse; Ana C Medeiros-Ribeiro; Carla G S Saad; Emily F N Yuki; Sandra G Pasoto; Léonard V K Kupa; Carina Ceneviva; Júlia C Seraphim; Tatiana N Pedrosa; Margarete B G Vendramini; Clóvis A Silva; Nádia E Aikawa; Eloisa Bonfá Journal: Rheumatology (Oxford) Date: 2022-08-03 Impact factor: 7.046
Authors: Laura Boekel; Laura Y Kummer; Koos P J van Dam; Femke Hooijberg; Zoé van Kempen; Erik H Vogelzang; Luuk Wieske; Filip Eftimov; Ronald van Vollenhoven; Taco W Kuijpers; S Marieke van Ham; Sander W Tas; Joep Killestein; Maarten Boers; Mike T Nurmohamed; Theo Rispens; Gertjan Wolbink Journal: Lancet Rheumatol Date: 2021-06-18
Authors: Albert Gil-Vila; Naveen Ravichandran; Albert Selva-O'Callaghan; Parikshit Sen; Arvind Nune; Prithvi Sanjeevkumar Gaur; Raquel Arànega Gonzalez; James B Lilleker; Mrudula Joshi; Vishwesh Agarwal; Sinan Kardes; Minchul Kim; Jessica Day; Ashima Makol; Marcin Milchert; Tamer Gheita; Babur Salim; Tsvetelina Velikova; Abraham Edgar Gracia-Ramos; Ioannis Parodis; Elena Nikiphorou; Ai Lyn Tan; Tulika Chatterjee; Lorenzo Cavagna; Miguel A Saavedra; Samuel Katsuyuki Shinjo; Nelly Ziade; Johannes Knitza; Masataka Kuwana; Oliver Distler; Hector Chinoy; Vikas Agarwal; Rohit Aggarwal; Latika Gupta Journal: Muscle Nerve Date: 2022-08-08 Impact factor: 3.852