2084: COVID-19 Vaccination in Autoimmune Diseases Study: Vaccine Safety in Systemic Lupus Erythematosus

Naveen R¹, Elena Nikiphorou², Mrudula Joshi³, Parikshit Sen⁴, Vishwesh Agarwal⁵, Sinan Kardes⁶, James B. Lilleker⁷, Hector Chinoy⁸, Oliver Distler⁹, Minchul Kim¹⁰, Ai Lyn Tan¹¹, Samuel Shinjo¹², Babur Salim¹³, Tamer A Gheita¹⁴, Nelly Ziade¹⁵, Tsvetelina Velikova¹⁶, Tulika Chatterjee¹⁰, Arvind Nune¹⁷, Marcin Milchert¹⁸, Abraham Edgar Gracia-Ramos¹⁹, Albert Selva O’Callaghan²⁰, Miguel Angel Saavedra Salinas²¹, Lorenzo Cavagna²², Masataka Kuwana²³, Johannes Knitza²⁴, Jessica Day²⁵, Ashima Makol²⁶, Rohit Aggarwal²⁷, Vikas Agarwal¹, Latika Gupta²⁸, Lisa S Traboco²⁹, CoVAD Study Group³⁰ and Ioannis Parodis³¹, ¹Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, ²Leiden University Medical Center & King's College London, London, United Kingdom, ³Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India, ⁴Maulana Azad Medical College, New Delhi, India, ⁵Mahatma Gandhi Missions Medical College, Lucknow, India, ⁶Istanbul University, Istanbul, Turkey, ⁷The University of Manchester, Manchester, United Kingdom, ⁸The University of Manchester, Sale, United Kingdom, ⁹Department of Rheumatology, University Hospital Zurich, University of Zurich, Zürich, Switzerland, ¹⁰University of Illinois College of Medicine Peoria, Peoria, IL, ¹¹University of Leeds, Leeds, United Kingdom, ¹²Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, Brazil, ¹³Fauji foundation hospital Rawalpindi, Rawalpindi, Pakistan, ¹⁴Rheumatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt, ¹⁵Saint-Joseph University, Beirut, Lebanon, ¹⁶Sofia University St. Kliment Ohridski, Sofia, Bulgaria, ¹⁷Southport and Ormskirk Hospital NHS Trust, Southport, United Kingdom, ¹⁸Pomeranian Medical University in Szczecin, Szczecin, Poland, ¹⁹Instituto Mexicano del Seguro Social, Ciudad de México, Mexico, ²⁰Hospital Universitari Vall d'Hebron, Barcelona, Spain, ²¹IMSS, Ciudad de México, Mexico, ²²Università di Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, Pavia, Italy, ²³Nippon Medical School Graduate School of Medicine, Tokyo, Japan, ²⁴Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054 Erlangen, Germany; Deutsches Zentrum Immuntherapie, Friedrich-Alexander-UniversityErlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany, ²⁵Walter and Eliza Hall Institute, Melbourne, Australia, ²⁶Mayo Clinic, Rochester, MN, Rochester, MN, ²⁷Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, ²⁸Royal Wolverhampton Trust, Wolverhampton/University of Manchester, United Kingdom, ²⁹St Luke's Medical Center - BGC, Manila, Philippines, ³⁰CoVAD study group, Wolwehampton, United Kingdom, ³¹Karolinska Institutet, Stockholm, Sweden

Background/Purpose: The COVID-19 vaccination in autoimmune diseases (COVAD) study is a large-scale real-world survey on COVID-19 vaccine safety in autoimmune rheumatic diseases (AIRDs), including systemic lupus erythematosus (SLE). The COVAD study aimed to assess adverse events (AEs) related to COVID-19 vaccination up to seven days post-vaccination in SLE patients.

Methods: The COVAD study group comprised >110 collaborators across 94 countries. The study was conducted in March-December 2021. An online survey platform captured self-reported COVID-19 vaccination-related AEs data in SLE, other AIRDs, other non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HCs). Active and inactive disease was patient self-reported. Descriptive statistics and multivariable regression adjusted for age, gender, ethnicity, vaccine type, and disease modifying anti-rheumatic drugs (DMARDs) were employed. Only odd's ratio significant in regression are reported in the results.

Results: Of the 9462 complete survey respondents, 5.5% (n=583) were SLE patients; those had a mean (SD) age of 40.1 (12) years, and 94.5% were females, 40.5% were Asians, and 71% had received 2 vaccine doses. Pfizer (43.1%) and Oxford/AstraZeneca(11.7%) were the most common vaccines received (Table 1).

Overall, vaccination-related AE were reported by 83.0% of SLE patients (83.0% reported minor and 2.6% major AE). Patients with active and inactive SLE reported similar AE and hospitalization frequencies. Among SLE patients, Pfizer recipients reported higher frequencies of overall AE [OR 2.1 (1.5–2.5), p=0.016], minor AE [OR 2.1 (1.5–2.5), p= 0.016], injection site pain [OR 1.3 (1.04–1.8), p < 0.001], and lower body ache [OR 0.4 (0.2–0.7), p=0.003] compared with recipients of other vaccines. Oxford/AstraZeneca recipients also reported higher frequencies of body ache [OR 2.5 (1.3–4.8), p=0.003], fever [OR 2.7 (1.4-5.2), p=0.002], and chills [OR 3.1 (1.3-6.6), p=0.005] compared with recipients of other vaccines. Moderna recipients reported higher frequencies of body ache, fever, chills, and rashes (OR ranging 2.6 to 4.3; Table 2). Sinopharm recipients reported lower frequencies of injection site pain [OR 0.2 (0.1-0.6), p=0.003]. Hospitalization frequencies were similar across vaccine types.

SLE patients on various DMARDs reported similar AE frequencies, except for less frequent chills reported by hydroxychloroquine users compared with non-users [OR 0.5 (0.3–0.9); Table 3]. When compared with AIRDs, nrAIDs, and HC, SLE patients reported similar overall AE and hospitalization frequencies, yet higher frequencies of rashes [OR 1.2 (1.01–1.5), p=0.038] compared with HC, lower frequencies of chills [OR 0.6 (0.4–0.8), p=0.005 and p=0.003] compared with AIRDs and nrAIDs, and lower frequencies of fatigue [OR 0.6 (0.4–0.9), p=0.020] compared with nrAIDs.

Conclusion: Despite differences in AEs across COVID-19 vaccines, all vaccines were overall well-tolerated in SLE patients. Similar AE frequencies were reported by patients with active and inactive SLE. AE frequencies were similar irrespective of background DMARD. These findings are reassuring with regard to safety of COVID-19 vaccination safety in SLE.
Table 1. Baseline characteristics of the respondents

Table 2. Vaccine related ADE among SLE patients based on the vaccine type

Table 3. Vaccine related ADE among SLE patients based on the Immunosuppression received
Disclosures: N. R, None; E. Nikiphorou, Pfizer, Celltrion, Sanofi, Gilead, Galapagos, AbbVie, Lilly, Fresenius; M. Joshi, None; P. Sen, None; V. Agarwal, None; S. Kardes, None; J. Lilleker, None; H. Chinoy, Eli Lilly, UCB; O. Distler, AbbVie/Abbott, Amgen, GlaxoSmithKlein(GSK), Novartis, Roche, UCB, Kymera, Mitsubishi Tanabe, Boehringer Ingelheim, 4P-Pharma, Acceleron, Alcimed, Altavant Sciences, AnaMar, Arxx, AstraZeneca, Blade Therapeutics, Bayer, Corbus Pharmaceuticals, CSL Behring, Galapagos, Glenmark, Horizon, Inventiva, Lupin, Miltenyi Biotec, Merck/MSD, Prometheus Biosciences, Redx Pharma, Roivant, Sanofi, Topadur, Pfizer, Janssen, Medscape, Patent issued “mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143), FOREUM Foundation, ERS/EULAR Guidelines, EUSTAR, SCQM (Swiss Clinical Quality Management in Rheumatic Diseases), Swiss Academy of Medical Sciences (SAMW), Hartmann Müller Foundation; M. Kim, None; A. Tan, None; S. Shinjo, None; B. Salim, None; T. Gheita, None; N. Ziade, Pfizer, Roche, AbbVie/Abbott, Eli Lilly, Boehringer-Ingelheim, Janssen; T. Velikova, None; T. Chatterjee, None; A. Nune, None; M. Milchert, None; A. Gracia-Ramos, None; A. O’Callaghan, None; M. Saavedra Salinas, GlaxoSmithKlein(GSK), AbbVie/Abbott; L. Cavagna, None; M. Kuwana, Boehringer-Ingelheim, Ono pharmaceuticals, Mochida, AbbVie/Abbott, Astellas, Janssen, Bayer, Corbus, Horizon; J. Knitza, AbbVie, Novartis, ThermoFisher, UCB, ABATON, Sanofi, Medac, Lilly, BMS, Gilead, GSK, Werfen, Vila Health, Böhringer Ingelheim, Janssen, Galapagos, Chugai; J. Day, CSL; A. Makol, Boehringer-Ingelheim; R. Aggarwal, Mallinckrodt, Bristol Myers Squibb, EMD Serono, Pfizer, Octapharma, CSL Behring, Q32, Kezar, AstraZeneca, Alexion, Argenx, Boehringer Ingelheim, Corbus, Janssen, Kyverna, Roivant, AbbVie, Jubilant, Orphazyme, Genentech; V. Agarwal, None; L. Gupta, None; L. Traboco, None; C. Study Group, None; I. Parodis, GlaxoSmithKlein(GSK), Amgen, AstraZeneca, Aurinia Pharmaceuticals, Eli Lilly, Gilead, Janssen, Novartis, Roche.