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COVID-19 Vaccination In Autoimmune Diseases (COVAD) Study: Vaccine Safety In Idiopathic Inflammatory Myopathies
- Source :
- Scientia
- Publication Year :
- 2022
-
Abstract
- COVID-19; Dermatomyositis; Vaccination COVID-19; Dermatomiositis; Vacunación COVID-19; Dermatomiositis; Vacunació 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. National Institution for Health Research Manchester Biomedical Research Centre (to H.C.).
- Subjects :
- Adult
Male
COVID-19 Vaccines
dermatomyositis
Physiology
Simian Acquired Immunodeficiency Syndrome
rheumatology
Keywords: COVID-19
Otros calificadores::Otros calificadores::/efectos adversos [Otros calificadores]
Autoimmune Diseases
Myositis, Inclusion Body
Cellular and Molecular Neuroscience
Physiology (medical)
Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy::Immunization::Immunotherapy, Active::Vaccination [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT]
Other subheadings::Other subheadings::/adverse effects [Other subheadings]
virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES]
Animals
Humans
BNT162 Vaccine
enfermedades musculoesqueléticas::enfermedades musculares::miositis [ENFERMEDADES]
Malalties autoimmunitàries
Immune System Diseases::Autoimmune Diseases [DISEASES]
enfermedades del sistema inmune::enfermedades autoinmunes [ENFERMEDADES]
COVID-19
Immunoglobulins, Intravenous
Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES]
myositis
vaccination
Exanthema
Musculoskeletal Diseases::Muscular Diseases::Myositis [DISEASES]
Inflamació
terapéutica::terapia biológica::inmunomodulación::inmunoterapia::inmunización::inmunoterapia activa::vacunación [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS]
Female
Neurology (clinical)
COVID-19 (Malaltia) - Vacunació
Hydroxychloroquine
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Scientia
- Accession number :
- edsair.doi.dedup.....d36f83395ea1887869c5065e3ccc181c