TY - JOUR
T1 - COVID-19 Vaccination-Related Delayed Adverse Events among Patients with Systemic Lupus Erythematosus
AU - COVAD Study Group
AU - Dey, Mrinalini
AU - Doskaliuk, Bohdana
AU - Lindblom, Julius
AU - Nikiphorou, Elena
AU - Wincup, Chris
AU - Fathima, Madiha
AU - Saha, Sreoshy
AU - Shaharir, Syahrul Sazliyana
AU - Katchamart, Wanruchada
AU - Goo, Phonpen Akarawatcharangura
AU - Traboco, Lisa
AU - Chen, Yi Ming
AU - Kadam, Esha
AU - Lilleker, James B.
AU - Nune, Arvind
AU - Pauling, John D.
AU - Agarwal, Vishwesh
AU - Dey, Dzifa
AU - Toro Gutierrez, Carlos Enrique
AU - Caballero, Carlo Vinicio
AU - Chinoy, Hector
AU - Aggarwal, Rohit
AU - Agarwal, Vikas
AU - Gupta, Latika
AU - Parodis, Ioannis
N1 - Publisher Copyright:
© 2023 by the authors.
PY - 2023/12
Y1 - 2023/12
N2 - Background: The safety profile of COVID-19 vaccination is well documented, but hesitancy among people with immune-mediated inflammatory diseases, often immunocompromised, remains high, partially due to a scarcity of data on safety over a longer term. We herein aimed to assess delayed adverse events (DAEs) occurring >7 days after COVID-19 vaccination in systemic lupus erythematosus (SLE) versus other rheumatic autoimmune diseases (rAIDs), non-rheumatic AIDs (nrAIDs), and healthy controls (HCs). Methods: Self-reported data were captured within the COVID-19 Vaccination in Autoimmune Diseases (COVAD)-2 online survey, which comprised >150 centres and responses from 106 countries, between February and June 2022. Logistic regression analysis adjusting for important confounders (age, sex, ethnicity) was used to compare groups. Results: Of 7203 eligible individuals, 882 (12.2%) patients had SLE, 3161 (43.9%) patients had rAIDs, 426 (5.9%) patients had nrAIDs, and 2734 (38.0%) were HCs. SLE patients had a median age of 39 years (IQR: 31–50); 93.7% were women. SLE patients reported, more frequently, major DAEs (OR: 1.6; 95% CI: 1.2–2.0; p = 0.001) and hospitalisation (OR: 2.2; 95% CI: 1.4–3.4; p < 0.001) compared to HCs, severe rashes (OR: 2.4; 95% CI: 1.3–4.2; p = 0.004) compared to people with rAIDS, and hospitalisation (OR: 2.3; 95% CI: 1.1–4.9; p = 0.029) as well as several minor DAEs compared to people with nrAIDs. Differences were observed between vaccines in terms of frequency of major DAEs and hospitalisations, with the latter seen more frequently in patients receiving the Moderna vaccine. People with SLE with no autoimmune multimorbidity less frequently reported overall minor DAEs compared to SLE patients with comorbid nrAIDs (OR: 0.5; 95% CI: 0.3–1.0; p = 0.036). Conclusion: Hospitalisations post-vaccination were more frequent in SLE patients than in HCs. Monitoring of SLE patients following COVID-19 vaccination can help in identifying DAEs early, informing patients about expected DAEs, and supporting patients, especially those with autoimmune multimorbidity.
AB - Background: The safety profile of COVID-19 vaccination is well documented, but hesitancy among people with immune-mediated inflammatory diseases, often immunocompromised, remains high, partially due to a scarcity of data on safety over a longer term. We herein aimed to assess delayed adverse events (DAEs) occurring >7 days after COVID-19 vaccination in systemic lupus erythematosus (SLE) versus other rheumatic autoimmune diseases (rAIDs), non-rheumatic AIDs (nrAIDs), and healthy controls (HCs). Methods: Self-reported data were captured within the COVID-19 Vaccination in Autoimmune Diseases (COVAD)-2 online survey, which comprised >150 centres and responses from 106 countries, between February and June 2022. Logistic regression analysis adjusting for important confounders (age, sex, ethnicity) was used to compare groups. Results: Of 7203 eligible individuals, 882 (12.2%) patients had SLE, 3161 (43.9%) patients had rAIDs, 426 (5.9%) patients had nrAIDs, and 2734 (38.0%) were HCs. SLE patients had a median age of 39 years (IQR: 31–50); 93.7% were women. SLE patients reported, more frequently, major DAEs (OR: 1.6; 95% CI: 1.2–2.0; p = 0.001) and hospitalisation (OR: 2.2; 95% CI: 1.4–3.4; p < 0.001) compared to HCs, severe rashes (OR: 2.4; 95% CI: 1.3–4.2; p = 0.004) compared to people with rAIDS, and hospitalisation (OR: 2.3; 95% CI: 1.1–4.9; p = 0.029) as well as several minor DAEs compared to people with nrAIDs. Differences were observed between vaccines in terms of frequency of major DAEs and hospitalisations, with the latter seen more frequently in patients receiving the Moderna vaccine. People with SLE with no autoimmune multimorbidity less frequently reported overall minor DAEs compared to SLE patients with comorbid nrAIDs (OR: 0.5; 95% CI: 0.3–1.0; p = 0.036). Conclusion: Hospitalisations post-vaccination were more frequent in SLE patients than in HCs. Monitoring of SLE patients following COVID-19 vaccination can help in identifying DAEs early, informing patients about expected DAEs, and supporting patients, especially those with autoimmune multimorbidity.
KW - COVID-19
KW - delayed adverse events
KW - systemic lupus erythematosus
KW - vaccines
UR - http://www.scopus.com/inward/record.url?scp=85180664309&partnerID=8YFLogxK
U2 - 10.3390/jcm12247542
DO - 10.3390/jcm12247542
M3 - Article
AN - SCOPUS:85180664309
SN - 2077-0383
VL - 12
JO - Journal of Clinical Medicine
JF - Journal of Clinical Medicine
IS - 24
M1 - 7542
ER -
