COVID-19 Vaccination-Related Delayed Adverse Events among Patients with Systemic Lupus Erythematosus

COVAD Study Group; Mrinalini Dey; Bohdana Doskaliuk; Julius Lindblom; Elena Nikiphorou; Chris Wincup; Madiha Fathima; Sreoshy Saha; Syahrul Sazliyana Shaharir; Wanruchada Katchamart; Phonpen Akarawatcharangura Goo; Lisa Traboco; Yi Ming Chen; Esha Kadam; James B. Lilleker; Arvind Nune; John D. Pauling; Vishwesh Agarwal; Dzifa Dey; Carlos Enrique Toro Gutierrez; Carlo Vinicio Caballero; Hector Chinoy; Rohit Aggarwal; Vikas Agarwal; Latika Gupta; Ioannis Parodis

doi:10.3390/jcm12247542

COVID-19 Vaccination-Related Delayed Adverse Events among Patients with Systemic Lupus Erythematosus

COVAD Study Group
, Mrinalini Dey
, Bohdana Doskaliuk
, Julius Lindblom
, Elena Nikiphorou
, Chris Wincup
, Madiha Fathima
, Sreoshy Saha
, Syahrul Sazliyana Shaharir
, Wanruchada Katchamart
, Phonpen Akarawatcharangura Goo
, Lisa Traboco
, Yi Ming Chen
, Esha Kadam
, James B. Lilleker
, Arvind Nune
, John D. Pauling
, Vishwesh Agarwal
, Dzifa Dey
, Carlos Enrique Toro Gutierrez

Carlo Vinicio Caballero, Hector Chinoy, Rohit Aggarwal, Vikas Agarwal, Latika Gupta, Ioannis Parodis^*

^*Corresponding author for this work

Inflammation and Ageing

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English
Article number	7542
Number of pages	14
Journal	Journal of Clinical Medicine
Volume	12
Issue number	24
DOIs	https://doi.org/10.3390/jcm12247542
Publication status	Published - 7 Dec 2023

Bibliographical note

Copyright:
© 2023 by the authors.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

COVID-19
delayed adverse events
systemic lupus erythematosus
vaccines

ASJC Scopus subject areas

General Medicine

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10.3390/jcm12247542Licence: Creative Commons: Attribution (CC BY)

Cite this

COVAD Study Group, Dey, M., Doskaliuk, B., Lindblom, J., Nikiphorou, E., Wincup, C., Fathima, M., Saha, S., Shaharir, S. S., Katchamart, W., Goo, P. A., Traboco, L., Chen, Y. M., Kadam, E., Lilleker, J. B., Nune, A., Pauling, J. D., Agarwal, V., Dey, D., ... Parodis, I. (2023). COVID-19 Vaccination-Related Delayed Adverse Events among Patients with Systemic Lupus Erythematosus. Journal of Clinical Medicine, 12(24), Article 7542. https://doi.org/10.3390/jcm12247542

@article{37fdef53bd9e48a1af51bdbe2e92e5d8,

title = "COVID-19 Vaccination-Related Delayed Adverse Events among Patients with Systemic Lupus Erythematosus",

abstract = "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.",

keywords = "COVID-19, delayed adverse events, systemic lupus erythematosus, vaccines",

author = "\{COVAD Study Group\} and Mrinalini Dey and Bohdana Doskaliuk and Julius Lindblom and Elena Nikiphorou and Chris Wincup and Madiha Fathima and Sreoshy Saha and Shaharir, \{Syahrul Sazliyana\} and Wanruchada Katchamart and Goo, \{Phonpen Akarawatcharangura\} and Lisa Traboco and Chen, \{Yi Ming\} and Esha Kadam and Lilleker, \{James B.\} and Arvind Nune and Pauling, \{John D.\} and Vishwesh Agarwal and Dzifa Dey and \{Toro Gutierrez\}, \{Carlos Enrique\} and Caballero, \{Carlo Vinicio\} and Hector Chinoy and Rohit Aggarwal and Vikas Agarwal and Latika Gupta and Ioannis Parodis",

note = "Copyright: {\textcopyright} 2023 by the authors.",

year = "2023",

month = dec,

day = "7",

doi = "10.3390/jcm12247542",

language = "English",

volume = "12",

journal = "Journal of Clinical Medicine",

issn = "2077-0383",

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COVAD Study Group, Dey, M, Doskaliuk, B, Lindblom, J, Nikiphorou, E, Wincup, C, Fathima, M, Saha, S, Shaharir, SS, Katchamart, W, Goo, PA, Traboco, L, Chen, YM, Kadam, E, Lilleker, JB, Nune, A, Pauling, JD, Agarwal, V, Dey, D, Toro Gutierrez, CE, Caballero, CV, Chinoy, H, Aggarwal, R, Agarwal, V, Gupta, L & Parodis, I 2023, 'COVID-19 Vaccination-Related Delayed Adverse Events among Patients with Systemic Lupus Erythematosus', Journal of Clinical Medicine, vol. 12, no. 24, 7542. https://doi.org/10.3390/jcm12247542

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

PY - 2023/12/7

Y1 - 2023/12/7

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 - https://www.scopus.com/pages/publications/85180664309

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 -

COVID-19 Vaccination-Related Delayed Adverse Events among Patients with Systemic Lupus Erythematosus

Abstract

Bibliographical note

UN SDGs

Keywords

ASJC Scopus subject areas

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