Factors Associated with Disease Flare Following SARS-CoV-2 Vaccination in People with Inflammatory Rheumatic and Musculoskeletal Diseases – Results from the Physician-Reported EULAR Coronavirus Vaccine (COVAX) Registry

Bayram Farisoğulları¹, Saskia Lawson-Tovey², Kimme Hyrich³, Laure Gossec⁴, Loreto Carmona⁵, Anja Strangfeld⁶, Elsa Mateus⁷, Martin Schaefer⁸, Ana Maria Rodrigues⁹, Eric Hachulla¹⁰, Jose A Gomez-Puerta¹¹, Marta Mosca¹², Patrick Durez¹³, Ludovic Trefond¹⁴, Tiphaine Goulenok¹⁵, Martina Cornalba¹⁶, Emoke Šteňová¹⁷, Inita Bulina¹⁸, Eva Strakova¹⁹, Julija Zepa²⁰, Nicolas Roux²¹, Olivier Brocq²², Viellard Eric²³, Bernd Raffeiner²⁴, Gerd Burmester²⁵, Xavier Mariette²⁶ and Pedro Machado²⁷, ¹Hacettepe University Faculty of Medicine Division of Rheumatology, Ankara, Turkey, ²Centre 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, ³The University of Manchester, Manchester, United Kingdom, ⁴Sorbonne Université, Paris, France, ⁵Instituto de Salud Musculoesquelética (InMusc), Madrid, Spain, ⁶Deutsches Rheuma-Forschungszentrum Berlin, Berlin, Germany, ⁷EULAR, Lisboa, Portugal, ⁸German Rheumatism Research Center, Berlin, Germany, ⁹Reuma.pt, Sociedade Portuguesa de Reumatologia, Lisbon, Portugal, ¹⁰University of Lille, LILLE, France, ¹¹Hospital Clínic de Barcelona, Barcelona, Spain, ¹²Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy, ¹³Rheumatology, Cliniques Universitaires Saint-Luc – Université catholique de Louvain (UCLouvain) – Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium, ¹⁴Université Clermont Auvergne, CHU Clermont-Ferrand, Service de Médecine Interne, Hôpital Gabriel Montpied, INSERM U1071, Clermont-Ferrand, France, ¹⁵APHP, Paris, France, ¹⁶Dipartimento di Reumatologia e Scienze Mediche, ASST Gaetano Pini-CTO, Milano, Italy, ¹⁷University Hospital, Bratislava, Slovakia, ¹⁸Center of Rheumatology, Paul Stradins Clinical University hospital, Riga, Latvia, Riga, Latvia, ¹⁹Department of Internal Medicine, Faculty Hospital Prešov, Presov, Slovakia, ²⁰Riga Stradins University, Latvia, Pauls Stradins Clinical University Hospital, Centre of Rheumatology, Riga, Latvia, Riga, Latvia, ²¹Service de Rhumatologie, Hôpital Robert Schuman, Metz, France, ²²Rheumatology- CH Princesse Grace, Monaco, Monaco, ²³Private practice, St. Malo, France, ²⁴Department of Rheumatology, Central Hospital of Bolzano, Bolzano, Italy, ²⁵Charité University Medicine Berlin, Berlin, Germany, ²⁶Paris-Saclay University, Rueil Malmaison, Ile-de-France, France, ²⁷University College London, London, United Kingdom

Meeting: ACR Convergence 2022

Keywords: autoimmune diseases, Autoinflammatory diseases, COVID-19, Disease Activity, risk factors

Session Information

Date: Monday, November 14, 2022

Title: Abstracts: Infection-related Rheumatic Disease

Session Type: Abstract Session

Session Time: 5:00PM-6:00PM

Background/Purpose: To investigate the frequency and factors associated with disease flare following vaccination against SARS-CoV-2 in people with inflammatory/autoimmune rheumatic and musculoskeletal diseases (I-RMD).

Methods: The European Alliance of Associations for Rheumatology (EULAR) Coronavirus Vaccine (COVAX) physician-reported registry is an observational registry of patients with a pre-existing inflammatory or non-inflammatory RMD who have received one or more doses of any vaccine against SARS-CoV-2. Four diagnostic groups were defined: (1) inflammatory joint diseases (IJD), (2) connective tissue diseases (CTD), (3) vasculitis, and (4) other I-RMD (OIRD). As disease activity was only collected at baseline, patients that received more than 2 vaccine doses were excluded from the analyses. Missing values for vaccine type and disease activity were derived by multiple imputation using full conditional specification. Predictors of flare were investigated using multivariable logistic regression adjusted for demographic and clinical factors. Two separate multivariable models were built, one using “disease flare” as dependent variable, and one using “new medication or dosage increase due to flare” as dependent variable.

Results: Of 10569 patients reported to the registry by 3 March 2022, 7336 were included in this study (Figure). Most patients had IJD (71%), followed by CTD (18%), vasculitis (9.4%), and OIRD (1.7%). Disease flares were reported in 272/7336 (3.7%) patients (Table 1). Flares requiring starting a new medication or increasing the dosage of an existing medication were reported in 121/7336 (1.6%) patients. Mean time between flare and the most recent vaccine dose was 7.2 days (SD 8.2) (Table 1). Age (OR 0.99, 95%CI 0.98-0.99), female sex (OR 1.42, 95%CI 1.06-1.89), active disease (low disease activity (LDA), OR 1.44, 95%CI 1.07-1.92; moderate/high disease activity (M/HDA), OR 1.38, 95%CI 0.98-1.95; vs remission), other vaccine types different from Pfizer/BioNTech, Oxford/AstraZeneca and Moderna (OR 0.10, 95%CI 0.01-0.73; vs Pfizer/BioNTech), rituximab exposure (OR 0.40, 95%CI 0.16-0.99), and cessation/reduction of anti-rheumatic medication before or after vaccination (OR 4.52, 95%CI 3.28-6.22) were factors independently associated with disease flare (Table 2). In the model using new medication or dosage increase due to flare as dependent variable (Table 2), active disease (LDA, OR 1.49, 95%CI 0.96-2.32; M/HDA, OR 3.13, 95%CI 1.96-5.01; vs remission), not using anti-rheumatic medication (OR 2.73, 95%CI 1.27-5.86), and cessation/reduction of anti-rheumatic medication before or after vaccination (OR 2.20, 95%CI 1.31-3.69) were the only factors independently associated with this more strict flare definition.

Conclusion: Flares of underlying I-RMD following SARS-CoV-2 vaccination were uncommon. Factors associated with potential flares were identified, namely higher disease activity and cessation/reduction of anti-rheumatic medications before or after vaccination. These data will inform SARS-CoV-2 vaccination strategies in patients with I-RMDs.

Disclosures: B. Farisoğulları, 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; M. Schaefer, None; A. Rodrigues, None; E. Hachulla, GlaxoSmithKline, Johnson & Johnson, Roche-Chugai, CSL Behring, Bayer, Boehringer Ingelheim, Sanofi-Genzyme; J. Gomez-Puerta, GSK, Galapagos, Pfizer, Janssen, Sanofi, AbbVie, Bristol Myers Squibb, Lilly, Novartis, MSD, Roche; M. Mosca, None; P. Durez, AbbVie, Galapagos, Lilly; L. Trefond, None; T. Goulenok, None; M. Cornalba, None; E. Šteňová, None; I. Bulina, AbbVie/Abbott, AstraZeneca, Janssen, Novartis; E. Strakova, None; J. Zepa, AbbVie/Abbott, Novartis, Janssen, AstraZeneca; N. Roux, None; O. Brocq, None; V. Eric, None; B. Raffeiner, None; G. Burmester, AbbVie, Galapagos, Lilly, MSD, Pfizer, Roche, UCB, Janssen, Gilead Sciences, Inc.; 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:

Farisoğulları B, Lawson-Tovey S, Hyrich K, Gossec L, Carmona L, Strangfeld A, Mateus E, Schaefer M, Rodrigues A, Hachulla E, Gomez-Puerta J, Mosca M, Durez P, Trefond L, Goulenok T, Cornalba M, Šteňová E, Bulina I, Strakova E, Zepa J, Roux N, Brocq O, Eric V, Raffeiner B, Burmester G, Mariette X, Machado P. Factors Associated with Disease Flare Following SARS-CoV-2 Vaccination in People with Inflammatory Rheumatic and Musculoskeletal Diseases – Results from the Physician-Reported EULAR Coronavirus Vaccine (COVAX) Registry [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/factors-associated-with-disease-flare-following-sars-cov-2-vaccination-in-people-with-inflammatory-rheumatic-and-musculoskeletal-diseases-results-from-the-physician-reported-eular-coronaviru/. Accessed .

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