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

Mrinalini Dey¹, Bohdana Doskaliuk², Julius Lindblom³, Elena Nikiphorou^{1

4}, Chris Wincup⁴, Madiha Fathima³, Sreoshy Saha⁵, Syahrul Sazliyana Shaharir⁶, Wanruchada Katchamart⁷, Phonpen Akarawatcharangura Goo⁸, Lisa Traboco⁹, Yi-Ming Chen^{10

11}, Esha Kadam¹², James B Lilleker^{13

14}, Arvind Nune¹⁵, John D Pauling^{16

17}, Vishwesh Agarwal¹⁸, Dzifa Dey¹⁹, Carlos Enrique Toro Gutierrez²⁰, Carlo Vinicio Caballero²¹, Hector Chinoy^{13

22}, Covad Study Group⁷, Rohit Aggarwal²³, Vikas Agarwal²⁴, Latika Gupta^{13

25

26}, Ioannis Parodis^{3

27}

Affiliations

¹ Centre for Rheumatic Diseases, King's College London, Weston Education Centre, Cutcombe Road, London SE5 9RJ, UK.
² Department of Pathophysiology, Ivano-Frankivsk National Medical University, 76018 Ivano-Frankivsk, Ukraine.
³ Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, 17176 Stockholm, Sweden.
⁴ Rheumatology Department, King's College Hospital, London SE5 9RS, UK.
⁵ Mymensingh Medical College, Mymensingh 2200, Bangladesh.
⁶ Faculty of Medicine, Universiti Kebangsaan Malaysia, Cheras, Kuala Lumpur 56000, Malaysia.
⁷ Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10100, Thailand.
⁸ Department of Medicine, Queen Savang Vadhana Memorial Hospital, Chonburi 20000, Thailand.
⁹ Department of Medicine, Section of Rheumatology, St. Luke's Medical Center-Global City, Taguig 1630, Philippines.
¹⁰ Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung 402, Taiwan.
¹¹ Department of Medical Research, Taichung Veterans General Hospital, Taichung 402, Taiwan.
¹² Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital, Mumbai 400001, Maharashtra, India.
¹³ Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester M13 9PL, UK.
¹⁴ Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust, Salford M16 0TT, UK.
¹⁵ Southport and Ormskirk Hospital NHS Trust, Southport PR8 6PN, UK.
¹⁶ Bristol Medical School Translational Health Sciences, University of Bristol, Bristol BS8 1QU, UK.
¹⁷ Department of Rheumatology, North Bristol NHS Trust, Bristol BS9 4RJ, UK.
¹⁸ Mahatma Gandhi Mission Medical College, Navi Mumbai 401208, Maharashtra, India.
¹⁹ Rheumatology Unit, Department of Medicine and Therapeutics, University of Ghana Medical School, College of Health Sciences, Korle-Bu, Accra KB 460, Ghana.
²⁰ Reference Center for Osteoporosis, Rheumatology and Dermatology, Pontifica Universidad Javeriana Cali, Cali 760046, Colombia.
²¹ Department of Medicine, Hospital Universidad del Norte, Barranquilla 081001, Colombia.
²² Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford M6 8HD, UK.
²³ Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA.
²⁴ Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 226014, Uttar Pradesh, India.
²⁵ Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton WV10 0QP, UK.
²⁶ Department of Rheumatology, City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham B71 4HJ, UK.
²⁷ Department of Rheumatology, Faculty of Medicine and Health, Örebro University, 70281 Örebro, Sweden.

PMID: 38137611
PMCID: PMC10743599
DOI: 10.3390/jcm12247542

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

Mrinalini Dey et al. J Clin Med. 2023.

. 2023 Dec 7;12(24):7542.

doi: 10.3390/jcm12247542.

Authors

Affiliations

¹ Centre for Rheumatic Diseases, King's College London, Weston Education Centre, Cutcombe Road, London SE5 9RJ, UK.
² Department of Pathophysiology, Ivano-Frankivsk National Medical University, 76018 Ivano-Frankivsk, Ukraine.
³ Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, 17176 Stockholm, Sweden.
⁴ Rheumatology Department, King's College Hospital, London SE5 9RS, UK.
⁵ Mymensingh Medical College, Mymensingh 2200, Bangladesh.
⁶ Faculty of Medicine, Universiti Kebangsaan Malaysia, Cheras, Kuala Lumpur 56000, Malaysia.
⁷ Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10100, Thailand.
⁸ Department of Medicine, Queen Savang Vadhana Memorial Hospital, Chonburi 20000, Thailand.
⁹ Department of Medicine, Section of Rheumatology, St. Luke's Medical Center-Global City, Taguig 1630, Philippines.
¹⁰ Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung 402, Taiwan.
¹¹ Department of Medical Research, Taichung Veterans General Hospital, Taichung 402, Taiwan.
¹² Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital, Mumbai 400001, Maharashtra, India.
¹³ Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester M13 9PL, UK.
¹⁴ Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust, Salford M16 0TT, UK.
¹⁵ Southport and Ormskirk Hospital NHS Trust, Southport PR8 6PN, UK.
¹⁶ Bristol Medical School Translational Health Sciences, University of Bristol, Bristol BS8 1QU, UK.
¹⁷ Department of Rheumatology, North Bristol NHS Trust, Bristol BS9 4RJ, UK.
¹⁸ Mahatma Gandhi Mission Medical College, Navi Mumbai 401208, Maharashtra, India.
¹⁹ Rheumatology Unit, Department of Medicine and Therapeutics, University of Ghana Medical School, College of Health Sciences, Korle-Bu, Accra KB 460, Ghana.
²⁰ Reference Center for Osteoporosis, Rheumatology and Dermatology, Pontifica Universidad Javeriana Cali, Cali 760046, Colombia.
²¹ Department of Medicine, Hospital Universidad del Norte, Barranquilla 081001, Colombia.
²² Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford M6 8HD, UK.
²³ Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA.
²⁴ Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 226014, Uttar Pradesh, India.
²⁵ Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton WV10 0QP, UK.
²⁶ Department of Rheumatology, City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham B71 4HJ, UK.
²⁷ Department of Rheumatology, Faculty of Medicine and Health, Örebro University, 70281 Örebro, Sweden.

PMID: 38137611
PMCID: PMC10743599
DOI: 10.3390/jcm12247542

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.

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Conflict of interest statement

H.C. was supported by the National Institution for Health Research Manchester Biomedical Research Centre Funding Scheme. The views expressed in this publication are those of the authors and not necessarily those of the NHS, National Institute for Health Research, or Department of Health. E.N. has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, and Lilly, and holds research grants from Pfizer and Lilly. I.P. has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia Pharmaceuticals, Elli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis, and F. Hoffmann-La Roche AG. H.C. has received grant support from Eli Lilly and UCB; consulting fees from Novartis, Eli Lilly, Orphazyme, and AstraZeneca; and is a speaker for UCB and Biogen. J.B.L. has received speaker honoraria/participated in advisory boards for Sanofi Genzyme, Roche, and Biogen. None are related to this manuscript. J.D.P. has undertaken consultancy work and/or received speaker honoraria from Astra Zenaca, Boeringer Ingelgheim, Sojournix Pharma, Permeatus Inc, Janssen, and IsoMab Pharmacueticals. R.A. has a consultancy relationship with and/or has received research funding from the following companies: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Kyverna Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, Roivant, Merck, Galapagos, Actigraph, Scipher, Horizon Therepeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio. The rest of the authors have no conflicts of interest relevant to this manuscript.

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

References

Grants and funding

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