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

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.
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.