Royal Wolverhampton NHS Trust Wolverhampton, United Kingdom
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Russka Shumnalieva1, Jennifer Hannah2, DEBADITYA ROY3, Naveen R4, Mahnoor Javaid5, Daniel Gonzalez6, Mrudula Joshi7, Abraham Edgar Gracia-Ramos8, Lorenzo Cavagna9, Parikshit Sen10, Jessica Day11, Sreoshy Saha12, Ioannis Parodis13, Elena Nikiphorou14, Esha Kadam15, Johannes Knitza16, Rohit Aggarwal17, Vikas Agarwal4 and Latika Gupta18, 1Clinic of Rheumatology, Department of Rheumatology, Medical University, Sofia, Bulgaria, 2King's College London, London, United Kingdom, 3Institute of Post Graduate Medical Education and Research Kolkata (IPGMER), Kolkata, India, 4Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow, India, 5The Aga Khan University, Karachi, Pakistan, 6Department of Rheumatology, University of Texas Medical Center, Galveston, TX, 7Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India, 8Department of Internal Medicine, General Hospital, National Medical Center "La Raza", Instituto Mexicano del Seguro Social, Av. Jacaranda S/N, Col. La Raza, Del. Azcapotzalco, C.P. 02990, Mexico City, Mexico, 9Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, 10Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi-110002, India., Dalhi, India, 11Walter and Eliza Hall Institute, Melbourne, Australia, 12Mymensingh Medical College, Faridpur, Bangladesh, 13Karolinska Institutet, Stockholm, Sweden, 14King's College London, London, United Kingdom, 15Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital, Mumbai, India, 16Department of Internal Medicine 3 Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg, University Hospital Erlangen, Erlangen, Germany, 17University of Pittsburgh, Pittsburgh, PA, 18Royal Wolverhampton Trust, Wolverhampton/University of Manchester, United Kingdom
Background/Purpose: We aim to describe the profile of new-onset systemic autoimmune diseases (SAID) developed in individuals following COVID-19 vaccination and to characterize the potential risk factors for their occurrence using a large-scale international survey.
Methods: A retrospective cohort study was conducted among participants who self-reported new-onset SAID in the COVAD-2 study - a global, validated, patient-reported e-survey involving 167 collaborators from 110 countries, to collect data on the long-term safety and tolerability of COVID-19 vaccines in patients with SAID (1). Responses are summarized using descriptive statistics including median (IQR) on the new onset of SAID. Baseline characteristics between those with new-onset SAIDs diagnosed by a rheumatologist and vaccinated healthy controls (HCs) are compared after 1:4 propensity score (PS) matched analysis based on age and gender variables. Predictors of new-onset SAIDs were assessed using binary logistic regression adjusting for age, gender, ethnicity, and country by HDI.
Results: Out of a total of 16,570 vaccinated respondents to the COVAD-2 survey, 628 reported a diagnosis of a new-onset SAID after receiving any dose of a COVID-19 vaccine. Of them 365 consented for a follow-up survey and 115 completed the survey. A total of 74 respondents with confirmed diagnosis of new-onset SAID were included in the final analysis (mean age was 52 years (range 18-82 years; SD: 14) and more than three-quarters were females (n=59, 79.7%)) (fig. 1). The most commonly reported new-onset SAIDs were idiopathic inflammatory myopathies (n=23, 31.1%) followed by inflammatory arthritis (n=15; 20.3%) and polymyalgia rheumatica (n=12, 16.2%) (fig. 2). The most commonly received COVID-19 vaccines leading to new-onset SAID were Pfizer (n=37, 37.4%) followed by Moderna (n=32, 32.3%) and then Oxford/AstraZeneca (n=26, 26.3%). The median (IQR) duration from vaccination to symptom onset was 14 (5-30) days. PS matched analysis between vaccinated HCs and new-onset SAIDs showed higher odds of new-onset SAIDs among Caucasians (OR: 5.3; 95%CI: 2.9-9.7; p< 0.001) and mRNA-1273 (Moderna) vaccine recipients (2.7; 1.3-5.3; 0.004) and lower odds among Asians (0.2; 0.1-0.7; 0.011) and BNT162b2 (Pfizer-BioNTech) vaccine (0.3; 0.2-0.7; 0.003) recipients. The predictors of new-onset SAIDs included presence of SAID multimorbidity (1.4; 1.1-1.7; < 0.001), mental health disorders (1.6; 1.3-1.9; < 0.001), and mixed race (2.2; 1.2-4.2; 0.010). Whereas, those with age >60 years (0.6; 0.4-0.8; 0.007), increasing vaccine doses (0.3; 0.2-0.5; < 0.001) and high/medium HDI countries (compared to very high HDI) (0.6; 0.4-0.8; 0.002) reported fewer new onset SAIDs.
Conclusion: This large case-series from the COVAD data set provides the first insights to new-onset SAID following COVID-19 vaccination in a global population. Due to disparity between patient and physician reporting, it is imperative to identify the correct diagnosis in individuals reporting new-onset SAID. Further research is therefore needed to facilitate counselling of individual risks and benefits, particularly if risk could be reduced by different COVID-19 vaccines schedules in predisposed individuals.
Figure 1. Flowchart showing process of study participants’ selection
Figure 2. Disease distribution of respondents developing new autoimmune disease after COVID-19 vaccination
R. Shumnalieva: None; J. Hannah: None; D. ROY: None; N. R: None; M. Javaid: None; D. Gonzalez: None; M. Joshi: None; A. Gracia-Ramos: None; L. Cavagna: None; P. Sen: None; J. Day: CSL limited, 5; S. Saha: None; I. Parodis: Amgen, 5, 6, AstraZeneca, 5, 6, Aurinia Pharmaceuticals, 5, 6, Bristol-Myers Squibb(BMS), 5, 6, Elli Lilly and Company, 5, 6, F. Hoffmann-La Roche AG, 5, 6, Gilead Sciences, 5, 6, GSK, 5, 6, Janssen Pharmaceuticals, 5, 6, Novartis, 5, 6, Otsuka Pharmaceutical, 5, 6; E. Nikiphorou: AbbVie/Abbott, 6, Celltrion, 6, Eli Lilly, 6, fresenius, 6, Galapagos, 6, Gilead, 1, 6, Pfizer, 6, Sanofi, 6; E. Kadam: None; J. Knitza: None; R. Aggarwal: Actigraph, 2, Alexion, 2, ANI Pharmaceuticals, 2, Argenx, 2, AstraZeneca, 2, Boehringer-Ingelheim, 2, 5, Bristol-Myers Squibb(BMS), 2, 5, CabalettaBio, 2, Capella Bioscience, 2, Corbus, 2, CSL Behring, 2, EMD Serono, 2, 5, Galapagos, 2, Horizon Therapeutics, 2, I-Cell, 2, Janssen, 2, 5, Kezar, 2, Kyverna, 2, Mallinckrodt, 5, Merck, 2, Octapharma, 2, Pfizer, 2, 5, Q32, 5, Roivant, 2, Sanofi, 2, Teva, 2; V. Agarwal: None; L. Gupta: None.
