Long-term safety of Covid vaccination in individuals with idiopathic inflammatory myopathies : results from the COVAD study
Doskaliuk, Bohdana Ravichandran, Naveen Sen, Parikshit Day, Jessica Joshi, Mrudula Nune, Arvind Nikiphorou, Elena Saha, Sreoshy Tan, Ai Lyn Shinjo, Samuel Katsuyuki
Doskaliuk, Bohdana
Ravichandran, Naveen
Sen, Parikshit
Day, Jessica
Joshi, Mrudula
Nune, Arvind
Nikiphorou, Elena
Saha, Sreoshy
Tan, Ai Lyn
Shinjo, Samuel Katsuyuki
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Affiliation
Ivano-Frankivsk National Medical University; Sanjay Gandhi Postgraduate Institute of Medical Sciences; Maulana Azad Medical College; Sandwell and West Birmingham NHS Trust
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Publication date
2023-06-23
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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 < 0.001]. IIM patients with active disease, overlap myositis, autoimmune comorbidities, and ChadOx1 nCOV-19 (Oxford/AstraZeneca) recipients reported AEs more often, while those with inclusion body myositis, and BNT162b2 (Pfizer) recipients reported fewer AEs. Vaccination is reassuringly safe in individuals with IIMs, with AEs, hospitalizations comparable to SAIDs, and largely limited to those with autoimmune multimorbidity and active disease. These observations may inform guidelines to identify high-risk patients warranting close monitoring in the post-vaccination period.
Citation
Doskaliuk B, Ravichandran N, Sen P, Day J, Joshi M, Nune A, Nikiphorou E, Saha S, Tan AL, Shinjo SK, Ziade N, Velikova T, Milchert M, Jagtap K, Parodis I, Gracia-Ramos AE, Cavagna L, Kuwana M, Knitza J, Chen YM, Makol A, Agarwal V, Patel A, Pauling JD, Wincup C, Barman B, Tehozol EAZ, Serrano JR, La Torre IG, Colunga-Pedraza IJ, Merayo-Chalico J, Chibuzo OC, Katchamart W, Goo PA, Shumnalieva R, Hoff LS, Kibbi LE, Halabi H, Vaidya B, Shaharir SS, Hasan ATMT, Dey D, Gutiérrez CET, Caballero-Uribe CV, Lilleker JB, Salim B, Gheita T, Chatterjee T, Distler O, Saavedra MA; COVAD study group; Chinoy H, Agarwal V, Aggarwal R, Gupta L. Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies: results from the COVAD study. Rheumatol Int. 2023 Sep;43(9):1651-1664. doi: 10.1007/s00296-023-05345-y
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Article