TY - JOUR
T1 - Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies
T2 - results from the COVAD study
AU - COVAD Study Group
AU - Bohdana, Doskaliuk
AU - Ravichandran, Naveen
AU - Sen, Parikshit
AU - Day, Jessica
AU - Joshi, Mrudula
AU - Nune, Arvind
AU - Nikiphorou, Elena
AU - Saha, Sreoshy
AU - Tan, Ai Lyn
AU - Shinjo, Samuel Katsuyuki
AU - Ziade, Nelly
AU - Velikova, Tsvetelina
AU - Milchert, Marcin
AU - Jagtap, Kshitij
AU - Parodis, Ioannis
AU - Gracia-Ramos, Abraham Edgar
AU - Cavagna, Lorenzo
AU - Kuwana, Masataka
AU - Knitza, Johannes
AU - Chen, Yi Ming
AU - Makol, Ashima
AU - Agarwal, Vishwesh
AU - Patel, Aarat
AU - Pauling, John D.
AU - Wincup, Chris
AU - Barman, Bhupen
AU - Tehozol, Erick Adrian Zamora
AU - Serrano, Jorge Rojas
AU - La Torre, Ignacio García De
AU - Colunga-Pedraza, Iris J.
AU - Merayo-Chalico, Javier
AU - Chibuzo, Okwara Celestine
AU - Katchamart, Wanruchada
AU - Goo, Phonpen Akarawatcharangura
AU - Shumnalieva, Russka
AU - Hoff, Leonardo Santos
AU - Kibbi, Lina El
AU - Halabi, Hussein
AU - Vaidya, Binit
AU - Shaharir, Syahrul Sazliyana
AU - Hasan, A. T.M.Tanveer
AU - Dey, Dzifa
AU - Gutiérrez, Carlos Enrique Toro
AU - Caballero-Uribe, Carlo V.
AU - Lilleker, James B.
AU - Salim, Babur
AU - Gheita, Tamer
AU - Chatterjee, Tulika
AU - Distler, Oliver
AU - Ugarte-Gil, Manuel Francisco
N1 - Publisher Copyright:
© 2023, The Author(s).
PY - 2023/9
Y1 - 2023/9
N2 - 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.
AB - 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.
KW - Adverse event
KW - Autoimmunity
KW - COVID-19
KW - Myositis
KW - Surveys and questionnaires
KW - Vaccination
UR - http://www.scopus.com/inward/record.url?scp=85162972096&partnerID=8YFLogxK
U2 - 10.1007/s00296-023-05345-y
DO - 10.1007/s00296-023-05345-y
M3 - Artículo
C2 - 37351634
AN - SCOPUS:85162972096
SN - 0172-8172
VL - 43
SP - 1651
EP - 1664
JO - Rheumatology International
JF - Rheumatology International
IS - 9
ER -