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Abstract Number: 0703

Vaccination Against SARS-CoV2 in Patients with Systemic Autoimmune Diseases: A Safety Report from EULAR COVAX Registry

Jose A Gomez-Puerta1, Ana Lúcia Martins Fernandes2, Juan Camilo Sarmiento-Monroy1, Saskia Lawson-Tovey3, Kimme Hyrich4, Laure Gossec5, Loreto Carmona6, Anja Strangfeld7, Elsa Mateus8, Ana Maria Rodrigues9, Eric Hachulla10, Marta Mosca11, Patrick Durez12, Bernd Raffeiner13, Nicolas Roux14, Viellard Eric15, Olivier Brocq16, Julija Zepa17, Eva Strakova18, Inita Bulina19, Vanda Mlynarikova20, Emoke Šteňová21, Martin Soubrier22, Xavier Mariette23 and Pedro Machado24, 1Hospital Clínic de Barcelona, Barcelona, Spain, 2Centro Hospitalar Universitário do Algarve, Faro, Portugal, 3Centre for Genetics and Genomics Versus Arthritis, Centre for Musculoskeletal Research, the University of Manchester, Manchester, UK AND National Institute of Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, 4The University of Manchester, Manchester, United Kingdom, 5Sorbonne Université, Paris, France, 6Instituto de Salud Musculoesquelética (InMusc), Madrid, Spain, 7Deutsches Rheuma-Forschungszentrum Berlin, Berlin, Germany, 8EULAR, Lisboa, Portugal, 9Reuma.pt, Sociedade Portuguesa de Reumatologia, Lisbon, Portugal, 10University of Lille, LILLE, France, 11Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy, 12Rheumatology, Cliniques Universitaires Saint-Luc – Université catholique de Louvain (UCLouvain) – Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium, 13Department of Rheumatology, Central Hospital of Bolzano, Bolzano, Italy, 14Service de Rhumatologie, Hôpital Robert Schuman, Metz, France, 15Private practice, St. Malo, France, 16Rheumatology- CH Princesse Grace, Monaco, Monaco, 17Riga Stradins University, Latvia, Pauls Stradins Clinical University Hospital, Centre of Rheumatology, Riga, Latvia, Riga, Latvia, 18Department of Internal Medicine, Faculty Hospital Prešov, Presov, Slovakia, 19Pauls Stradins Clinical University Hospital, Riga, Riga, Latvia, 20National Institute of Rheumatic Diseases, Piešťany, Slovakia, 21University Hospital, Bratislava, Slovakia, 22Gabriel-Montpied Hospital, Clermont-Ferrand, France, 23Paris-Saclay University, Rueil Malmaison, Ile-de-France, France, 24University College London, London, United Kingdom

Meeting: ACR Convergence 2022

Keywords: autoimmune diseases, COVID-19, prevention

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Session Information

Date: Sunday, November 13, 2022

Title: Epidemiology and Public Health Poster I

Session Type: Poster Session B

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

Background/Purpose: Some concerns have been raised with the use of vaccines against SARS-CoV-2 in patients with Systemic Autoimmune Diseases (SAD) including the risk of serious adverse events. Our objetive was to describe the safety of vaccines against SARS-CoV-2 in people with SAD.

Methods: We used data from the European Alliance of Associations for Rheumatology (EULAR) Coronavirus Vaccine (COVAX) physician-reported registry (EULAR-COVAX). EULAR-COVAX recently reported global results in inflammatory and non-inflammatory rheumatic and musculoskeletal diseases (RMD) (1). We included patients with SAD reported to the registry from February 2021 to 3 March 2022 including patients with large, medium and small vessel vasculitis, ANCA-associated vasculitis, systemic lupus erythematosus (SLE), primary antiphospholipid syndrome (APS), Sjögren syndrome (SS), systemic sclerosis (SSc), inflammatory myositis, mixed connective tissue disease (MCTD) and undifferentiated connective tissue disease (UCTD). Patients with giant cell arteritis (GCA) and polymyalgia rheumatica (PMR) were grouped. Data on demographics, vaccination, RMD diagnosis, disease activity, immunomodulatory/ immunosuppressive treatments, early adverse events (reactogenicity) and adverse events of special interest were collected. Data were analysed descriptively.

Results: A total of 2570 (24.3%) out of 10569 patients included in the registry had a diagnosis of SAD. The study included patients from 31 countries, mostly female (76.7 %), with a mean age  of 57.8 (SD 16.6) years. A total of 164 (6.4%) patients had previous SARS-CoV2 infection before vaccination. The main diagnoses included SLE (n=761), GCA plus PMR (n=474), SS (n=349), SSc (n=288), ANCA-associated vasculitis (n=167), inflammatory myositis (n=103), UCTD (n=86), MCTD (n=53), primary APS (n=40), Takayasu (n=24), medium vessel vasculitis (n=18) and other vasculitis (n=11). Clinical characteristics of patients with more common SAD are shown in Table 1.

A total of 1618 (62.9%) early adverse events were reported. Pain at the site of injection in 480 (18.6%) patients, fatigue in 285 (11.0%), fever in 205 (7.9%) generalized muscle pain in 176 (6.8%), headache in 159 (6.1%), among others. Adverse events of special interest were reported in 53 (1.9%) patients (46 mild or moderate and 7 severe).

Conclusion: In this international physician-reported SARS-CoV-2 vaccination registry, patients with SAD had a favourable outcome with very good vaccine tolerance and safety. The frequency of early side effects (reactogenicity) was similar to the general population.  Only a very small proportion of patients (< 2%) had adverse events of special interest and most of them were mild or moderate.

Supporting image 1

Table 1. Characteristics of the study population stratified by systemic autoimmune Disease


Disclosures: J. Gomez-Puerta, GSK, Galapagos, Pfizer, Janssen, Sanofi, AbbVie, Bristol Myers Squibb, Lilly, Novartis, MSD, Roche; A. Martins Fernandes, None; J. Sarmiento-Monroy, None; S. Lawson-Tovey, None; K. Hyrich, AbbVie/Abbott, Pfizer, Bristol-Myers Squibb(BMS); L. Gossec, Amgen, Lilly, Pfizer, Sandoz, UCB Pharma, AbbVie, Bristol Myers Squibb, Gilead, Janssen, Novartis, Samsung Bioepis, Sanofi-Aventis, Galapagos, GlaxoSmithKlein (GSK), Celltrion, MSD; L. Carmona, None; A. Strangfeld, AbbVie/Abbott, Merck/MSD, Roche, Bristol-Myers Squibb(BMS), Pfizer; E. Mateus, None; A. Rodrigues, None; E. Hachulla, GlaxoSmithKline, Johnson & Johnson, Roche-Chugai, CSL Behring, Bayer, Boehringer Ingelheim, Sanofi-Genzyme; M. Mosca, None; P. Durez, AbbVie, Galapagos, Lilly; B. Raffeiner, None; N. Roux, None; V. Eric, None; O. Brocq, None; J. Zepa, AbbVie/Abbott, Novartis, Janssen, AstraZeneca; E. Strakova, None; I. Bulina, None; V. Mlynarikova, None; E. Šteňová, None; M. Soubrier, None; X. Mariette, AstraZeneca, Bristol Myers Squibb, Galapagos, GSK, Novartis, Pfizer; P. Machado, AbbVie/Abbott, Eli Lilly, UCB, Novartis, Orphazyme, Galapagos.

To cite this abstract in AMA style:

Gomez-Puerta J, Martins Fernandes A, Sarmiento-Monroy J, Lawson-Tovey S, Hyrich K, Gossec L, Carmona L, Strangfeld A, Mateus E, Rodrigues A, Hachulla E, Mosca M, Durez P, Raffeiner B, Roux N, Eric V, Brocq O, Zepa J, Strakova E, Bulina I, Mlynarikova V, Šteňová E, Soubrier M, Mariette X, Machado P. Vaccination Against SARS-CoV2 in Patients with Systemic Autoimmune Diseases: A Safety Report from EULAR COVAX Registry [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/vaccination-against-sars-cov2-in-patients-with-systemic-autoimmune-diseases-a-safety-report-from-eular-covax-registry/. Accessed .
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