TY - JOUR
T1 - COVID-19 Vaccination in Autoimmune Diseases (COVAD) study
T2 - Vaccine safety in idiopathic inflammatory myopathies
AU - and the COVAD Study Group
AU - Gil-Vila, Albert
AU - Ravichandran, Naveen
AU - Selva-O'Callaghan, Albert
AU - Sen, Parikshit
AU - Nune, Arvind
AU - Gaur, Prithvi Sanjeevkumar
AU - Gonzalez, Raquel Arànega
AU - Lilleker, James B.
AU - Joshi, Mrudula
AU - Agarwal, Vishwesh
AU - Kardes, Sinan
AU - Kim, Minchul
AU - Day, Jessica
AU - Makol, Ashima
AU - Milchert, Marcin
AU - Gheita, Tamer
AU - Salim, Babur
AU - Velikova, Tsvetelina
AU - Gracia-Ramos, Abraham Edgar
AU - Parodis, Ioannis
AU - Nikiphorou, Elena
AU - Tan, Ai Lyn
AU - Chatterjee, Tulika
AU - Cavagna, Lorenzo
AU - Saavedra, Miguel A.
AU - Shinjo, Samuel Katsuyuki
AU - Ziade, Nelly
AU - Knitza, Johannes
AU - Kuwana, Masataka
AU - Distler, Oliver
AU - Chinoy, Hector
AU - Agarwal, Vikas
AU - Aggarwal, Rohit
AU - Gupta, Latika
N1 - Publisher Copyright:
© 2022 The Authors. Muscle & Nerve published by Wiley Periodicals LLC.
PY - 2022/10
Y1 - 2022/10
N2 - 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.
AB - 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.
KW - COVID-19
KW - dermatomyositis
KW - myositis
KW - rheumatology
KW - vaccination
UR - http://www.scopus.com/inward/record.url?scp=85136824477&partnerID=8YFLogxK
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U2 - 10.1002/mus.27681
DO - 10.1002/mus.27681
M3 - Article
C2 - 35869701
AN - SCOPUS:85136824477
SN - 0148-639X
VL - 66
SP - 426
EP - 437
JO - Muscle and Nerve
JF - Muscle and Nerve
IS - 4
ER -