COVID-19 Vaccination in Autoimmune Diseases (COVAD) study: Vaccine safety in idiopathic inflammatory myopathies

Gil-Vila A, Ravichandran N, Selva-O'Callaghan A, Sen P, Nune A, Gaur PS, Gonzalez RA, Lilleker JB, Joshi M, Agarwal V, Kardes S, Kim M, Day J, Makol A, Milchert M, Gheita T, Salim B, Velikova T, Gracia-Ramos AE, Parodis I, Nikiphorou E, Tan AL, Chatterjee T, Cavagna L, Saavedra MA, Shinjo SK, Ziade N, Knitza J, Kuwana M, Distler O, Chinoy H, Agarwal V, Aggarwal R, Gupta L (2022)

Publication Type: Journal article

Publication year: 2022

Journal

DOI: 10.1002/mus.27681

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.

Authors with CRIS profile

Involved external institutions

Royal Melbourne Hospital (RMH) Australia (AU) Mayo Clinic United States (USA) (US) Pomeranian Medical University / Pomorski Uniwersytet Medyczny w Szczecinie (PMU) Poland (PL) Cairo University Egypt (EG) Fauji Foundation Hospital Pakistan (PK) Sofia University "St. Kliment Ohridski" / Софийски университет "Св. Климент Охридски" Bulgaria (BG) Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS) India (IN) Autonomous University of Barcelona (UAB) / Universitat Autònoma de Barcelona Spain (ES) Maulana Azad Medical College (MAMC) India (IN) Southport and Ormskirk Hospital NHS Trust United Kingdom (GB) Smt. Kashibai Navale Medical College and General hospital India (IN) Hospital Clínic de Barcelona Spain (ES) University of Manchester United Kingdom (GB) Byramjee Jeejeebhoy Government Medical College & Sassoon General Hospital India (IN) Instituto Mexicano del Seguro Social Mexico (MX) Universitätsspital Zürich (USZ) Switzerland (CH) University of Pittsburgh United States (USA) (US) Mahatma Gandhi Mission Medical College and Hospital India (IN) Istanbul University / İstanbul Üniversitesi Turkey (TR) University of Illinois at Chicago United States (USA) (US) Karolinska University Hospital / Karolinska Universitetssjukhuset Sweden (SE) King’s College London United Kingdom (GB) Leeds Teaching Hospitals NHS Trust United Kingdom (GB) Policlinico San Matteo Pavia Fondazione IRCCS Italy (IT) Centro Medico Nacional Siglo XXI Mexico (MX) University of São Paulo / Universidade de São Paulo (USP) Brazil (BR) Université Saint-Joseph (USJ) / جامعة القديس يوسف / Սուրբ Ժոզեֆի համալսարան Lebanon (LB)

How to cite

APA:

Gil-Vila, A., Ravichandran, N., Selva-O'Callaghan, A., Sen, P., Nune, A., Gaur, P.S.,... Gupta, L. (2022). COVID-19 Vaccination in Autoimmune Diseases (COVAD) study: Vaccine safety in idiopathic inflammatory myopathies. Muscle & Nerve. https://doi.org/10.1002/mus.27681

MLA:

Gil-Vila, Albert, et al. "COVID-19 Vaccination in Autoimmune Diseases (COVAD) study: Vaccine safety in idiopathic inflammatory myopathies." Muscle & Nerve (2022).

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