Safety of Vaccination against SARS-CoV-2 in People with Rheumatic and Musculoskeletal Diseases: Results from the EULAR Coronavirus Vaccine (COVAX) Physician-Reported Registry
Pedro M Machado
(1)
,
Saskia Lawson-Tovey
(2, 3)
,
Anja Strangfeld
(4)
,
Elsa F Mateus
,
Kimme L Hyrich
(2, 3)
,
Laure Gossec
(5, 6)
,
Loreto Carmona
(7)
,
Ana Rodrigues
,
Bernd Raffeiner
(8)
,
Catia Duarte
(9)
,
Eric Hachulla
(10, 11)
,
Eric Veillard
,
Eva Strakova
,
Gerd R Burmester
(12)
,
Gözde Kübra Yardımcı
(13)
,
Jose A Gomez-Puerta
,
Julija Zepa
,
Lianne Kearsley-Fleet
(14)
,
Ludovic Trefond
(15, 16)
,
Maria Cunha
,
Marta Mosca
(17)
,
Martina Cornalba
,
Martin Soubrier
(18)
,
Nicolas Roux
,
Olivier Brocq
(19)
,
Patrick Durez
(20)
,
Richard Conway
,
Tiphaine Goulenok
(21)
,
Johannes Wj Bijlsma
(22)
,
Iain B Mcinnes
,
Xavier Mariette
(23)
1
UCLH -
University College London Hospitals
2 MAHSC - Manchester Academic Health Science Centre
3 Centre for Genetics and Genomics Versus Arthritis
4 DRFZ - Deutsches Rheuma-ForschungsZentrum
5 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
6 CHU Pitié-Salpêtrière [AP-HP]
7 InMusc - Instituto de Salud Musculoesqueletica
8 Bolzano Central Hospital = Ospedale Provinciale di Bolzano
9 Centro Hospitalar e Universitário [Coimbra]
10 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
11 INFINITE (Ex-Liric) - Institute for Translational Research in Inflammation - U 1286
12 Department of Rheumatology and Clinical Immunology
13 Faculty of Medicine [Hacettepe University]
14 University of Manchester [Manchester]
15 M2iSH - Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte
16 Service de Médecine Interne [CHU Clermont-Ferrand]
17 University of Pisa - Università di Pisa
18 CHU Clermont-Ferrand
19 Hôpital Princesse Grace [Monaco]
20 Cliniques Universitaires Saint-Luc [Bruxelles]
21 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
22 University Medical Center [Utrecht]
23 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
2 MAHSC - Manchester Academic Health Science Centre
3 Centre for Genetics and Genomics Versus Arthritis
4 DRFZ - Deutsches Rheuma-ForschungsZentrum
5 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
6 CHU Pitié-Salpêtrière [AP-HP]
7 InMusc - Instituto de Salud Musculoesqueletica
8 Bolzano Central Hospital = Ospedale Provinciale di Bolzano
9 Centro Hospitalar e Universitário [Coimbra]
10 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
11 INFINITE (Ex-Liric) - Institute for Translational Research in Inflammation - U 1286
12 Department of Rheumatology and Clinical Immunology
13 Faculty of Medicine [Hacettepe University]
14 University of Manchester [Manchester]
15 M2iSH - Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte
16 Service de Médecine Interne [CHU Clermont-Ferrand]
17 University of Pisa - Università di Pisa
18 CHU Clermont-Ferrand
19 Hôpital Princesse Grace [Monaco]
20 Cliniques Universitaires Saint-Luc [Bruxelles]
21 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
22 University Medical Center [Utrecht]
23 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
Elsa F Mateus
- Fonction : Auteur
Ana Rodrigues
- Fonction : Auteur
Eric Hachulla
- Fonction : Auteur
- PersonId : 1366882
- ORCID : 0000-0001-7432-847X
- IdRef : 031788866
Eric Veillard
- Fonction : Auteur
Eva Strakova
- Fonction : Auteur
Jose A Gomez-Puerta
- Fonction : Auteur
Julija Zepa
- Fonction : Auteur
Maria Cunha
- Fonction : Auteur
Martina Cornalba
- Fonction : Auteur
Martin Soubrier
- Fonction : Auteur
- PersonId : 760322
- ORCID : 0000-0001-9349-0720
- IdRef : 074723375
Nicolas Roux
- Fonction : Auteur
Richard Conway
- Fonction : Auteur
Iain B Mcinnes
- Fonction : Auteur
Xavier Mariette
- Fonction : Auteur
- PersonId : 756829
- ORCID : 0000-0002-4244-5417
- IdRef : 113094116
Résumé
Objectives To describe the safety of vaccines against SARS-CoV-2 in people with inflammatory/autoimmune rheumatic and musculoskeletal disease (I-RMD). Methods Physician-reported registry of I-RMD and non-inflammatory RMD (NI-RMDs) patients vaccinated against SARS-CoV-2. From 5 February 2021 to 27 July 2021, we collected data on demographics, vaccination, RMD diagnosis, disease activity, immunomodulatory/immunosuppressive treatments, flares, adverse events (AEs) and SARS-CoV-2 breakthrough infections. Data were analysed descriptively. Results The study included 5121 participants from 30 countries, 90% with I-RMDs (n=4604, 68% female, mean age 60.5 years) and 10% with NI-RMDs (n=517, 77% female, mean age 71.4). Inflammatory joint diseases (58%), connective tissue diseases (18%) and vasculitis (12%) were the most frequent diagnostic groups; 54% received conventional synthetic disease-modifying antirheumatic drugs (DMARDs), 42% biological DMARDs and 35% immunosuppressants. Most patients received the Pfizer/BioNTech vaccine (70%), 17% AstraZeneca/Oxford and 8% Moderna. In fully vaccinated cases, breakthrough infections were reported in 0.7% of I-RMD patients and 1.1% of NI-RMD patients. I-RMD flares were reported in 4.4% of cases (0.6% severe), 1.5% resulting in medication changes. AEs were reported in 37% of cases (37% I-RMD, 40% NI-RMD), serious AEs in 0.5% (0.4% I-RMD, 1.9% NI-RMD). Conclusion The safety profiles of SARS-CoV-2 vaccines in patients with I-RMD was reassuring and comparable with patients with NI-RMDs. The majority of patients tolerated their vaccination well with rare reports of I-RMD flare and very rare reports of serious AEs. These findings should provide reassurance to rheumatologists and vaccine recipients and promote confidence in SARS-CoV-2 vaccine safety in I-RMD patients.