0895: COVID-19 Vaccination in Autoimmune Diseases Study: Vaccine Safety in Rheumatoid Arthritis

Naveen R¹, Ioannis Parodis², Mrudula Joshi³, Parikshit Sen⁴, Minchul Kim⁵, Vishwesh Agarwal⁶, Sinan Kardes⁷, James B. Lilleker⁸, Hector Chinoy⁹, Oliver Distler¹⁰, Ai Lyn Tan¹¹, Samuel Shinjo¹², Babur Salim¹³, Tamer A Gheita¹⁴, Nelly Ziade¹⁵, Tsvetelina Velikova¹⁶, Tulika Chatterjee⁵, 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, John Pauling²⁷, Chris Wincup²⁸, Erick Zamora Tehozol²⁹, Jorge Rojas Serrano³⁰, Ignacio Garcia-De La Torre³¹, Rohit Aggarwal³², Vikas Agarwal¹, Latika Gupta³³, Elena Nikiphorou³⁴ and CoVAD Study Group³⁵, ¹Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, ²Karolinska Institutet, Stockholm, Sweden, ³Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India, ⁴Maulana Azad Medical College, New Delhi, India, ⁵University of Illinois College of Medicine Peoria, Peoria, IL, ⁶Mahatma Gandhi Missions Medical College, Lucknow, India, ⁷Istanbul University, Istanbul, Turkey, ⁸The University of Manchester, Manchester, United Kingdom, ⁹The University of Manchester, Sale, United Kingdom, ¹⁰Department of Rheumatology, University Hospital Zurich, University of Zurich, Zürich, Switzerland, 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, ²⁷North Bristol NHS Trust, Bristol, United Kingdom, ²⁸Rayne Institute, University College London, London, United Kingdom, ²⁹Centro Medico Pensiones, Merida, Mexico, ³⁰Hospital Angeles Villahermosa, Ciudad de México, Mexico, ³¹Centro de Est. de Inv. Bas. y Clinica, S.C., Guadalajara, Mexico, ³²Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, ³³Royal Wolverhampton Trust, Wolverhampton/University of Manchester, United Kingdom, ³⁴Leiden University Medical Center & King's College London, London, United Kingdom, ³⁵CoVAD study group, Wolwehampton, United Kingdom

Background/Purpose: COVID-19 vaccination in autoimmune diseases (COVAD) study is a large-scale real-world data on COVID-19 vaccine safety in autoimmune rheumatic diseases (AIRDs) including rheumatoid arthritis (RA). The COVAD study aimed to assess COVID-19 vaccination-related adverse events (AEs) till seven days post-vaccination in RA patients.

Methods: COVAD study group comprised >110 collaborators across 94 countries. The Study was conducted from March 2021 to December 2021. Survey monkey platform-based self-reported online survey captured the data related to COVID-19 vaccination-related AEs in RA, other AIRDs, other (non-rheumatic) autoimmune diseases (nrAIDs), and healthy controls (HCs). Active and inactive disease were patient self-reported and decided based on the need for hiking immunosuppression prior to vaccination. Descriptive and multivariable regression analyses adjusting for age, gender, ethnicity, vaccine type, and disease modifying anti-rheumatic drugs (DMARDs) were performed. Statistically significant results following multivariate regression are reported.

Results: Of the 9462 total complete respondents, 14% (n=1347) were RA patients, with a mean (SD) age 50.7 (13.7) years, 87% were females, 56% were Caucasian, and 71% had completed 2 doses. BNT162b2 (Pfizer) (39.1%) and ChAdOx1 nCoV-19 (Oxford)(23.8%) were the most common vaccines received (Table 1). Overall, 77.1% of RA patients reported AEs (77.1%-minor and 4.2% -major). Active RA had similar AEs and hospitalization compared to inactive RA. Between the different vaccines, mRNA 1273 (Moderna) recipients had reported highest overall AEs, minor AEs [OR for both 3.1 (1.4-6.6), p 0.003], and injection site pain [OR 2.5 (1.5-4.3), p< 0.001]. Similarly, Pfizer recipients too reported higher overall AE, minor AEs [OR for both 1.3 (1.03-1.8), p 0.027], and injection site pain [OR 2.1 (1.5-2.5), p< 0.001] compared to the rest. Oxford recipients had higher frequencies of myalgia, fever, chills, nausea/vomiting, headache, and fatigue compared to the rest of vaccine recipients (Table 2). ChAdOx1 nCoV-19 (Covishield), BBV152 (Covaxin), and BBIBP-CorV (Sinopharm) recipients had reported lower AEs compared to the rest. RA patients on different DMARDs reported similar AEs except for patients on methotrexate and hydroxychloroquine who reported fewer minor AEs (Table 3). When compared to HC and AIRDs, RA patients reported similar overall AEs, injection site pain, overall minor AEs, and hospitalizations, except for higher frequencies of dizziness compared to HC [OR 1.4 (1.1-2), p 0.010], and lower frequencies of fatigue [OR 0.8 (0.6-0.9), p 0.015] compared to AIRDs. When compared to other nrAIDs, RA reported lower overall AEs [OR 0.7 (0.5-0.9), p 0.017], injection site pain [OR 0.6 (0.5-0.8), p 0.002] and minor AEs [OR 0.7 (0.5-0.9), p 0.017]. Major AEs and hospitalization were similar between RA, AIRDs, nrAIDs and HC.

Conclusion: Despite differences in the frequencies of AEs between different COVID-19 vaccines, all were largely well tolerated in RA patients. Frequencies of AEs were no different between active versus inactive RA. The findings of the present study provide reassurance on safety of COVID-19 vaccination in RA.
Table 1. Baseline characteristics of the cohort

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

Table 3. Vaccine related ADE among RA patients based on the Immunosuppression received
Disclosures: N. R, None; I. Parodis, GlaxoSmithKlein(GSK), Amgen, AstraZeneca, Aurinia Pharmaceuticals, Eli Lilly, Gilead, Janssen, Novartis, Roche; M. Joshi, None; P. Sen, None; M. Kim, 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; 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; J. Pauling, None; C. Wincup, None; E. Zamora Tehozol, None; J. Rojas Serrano, None; I. Garcia-De La Torre, None; 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; E. Nikiphorou, Pfizer, Celltrion, Sanofi, Gilead, Galapagos, AbbVie, Lilly, Fresenius; C. Study Group, None.