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

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; Covad Study Group; 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

J Clin Med. 2023 Dec 7;12(24):7542. doi: 10.3390/jcm12247542.

Authors

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.

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.

Grants and funding

IP is supported by grants from the Swedish Rheumatism Association (R-969696), King Gustaf V’s 80-year Foundation (FAI-2020-0741), Swedish Society of Medicine (SLS-974449), Nyckelfonden (OLL-974804), Professor Nanna Svartz Foundation (2021-00436), Ulla and Roland Gustafsson Foundation (2021-26), Region Stockholm (FoUI-955483), and Karolinska Institutet.