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Abstract Number: 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

Meeting: ACR Convergence 2022

Keywords: COVID-19, rheumatoid arthritis, Surveys

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Session Information

Date: Sunday, November 13, 2022

Title: RA – Diagnosis, Manifestations, and Outcomes Poster II

Session Type: Poster Session B

Session Time: 9:00AM-10:30AM

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.

Supporting image 1

Table 1. Baseline characteristics of the cohort

Supporting image 2

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

Supporting image 3

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.

To cite this abstract in AMA style:

R N, Parodis I, Joshi M, Sen P, Kim M, Agarwal V, Kardes S, Lilleker J, Chinoy H, Distler O, Tan A, Shinjo S, Salim B, Gheita T, Ziade N, Velikova T, Chatterjee T, Nune A, Milchert M, Gracia-Ramos A, O’Callaghan A, Saavedra Salinas M, Cavagna L, Kuwana M, Knitza J, Day J, Makol A, Pauling J, Wincup C, Zamora Tehozol E, Rojas Serrano J, Garcia-De La Torre I, Aggarwal R, Agarwal V, Gupta L, Nikiphorou E, Study Group C. COVID-19 Vaccination in Autoimmune Diseases Study: Vaccine Safety in Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/covid-19-vaccination-in-autoimmune-diseases-study-vaccine-safety-in-rheumatoid-arthritis/. Accessed .
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