. 2022 May;81(5):695-709.

doi: 10.1136/annrheumdis-2021-221490. Epub 2021 Dec 31.

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

2

3}, Saskia Lawson-Tovey^{4

5}, Anja Strangfeld⁶, Elsa F Mateus^{7

8}, Kimme L Hyrich^{4

5}, Laure Gossec^{9

10}, Loreto Carmona¹¹, Ana Rodrigues^{12

13

14}, Bernd Raffeiner¹⁵, Catia Duarte^{12

16

17}, Eric Hachulla¹⁸, Eric Veillard¹⁹, Eva Strakova²⁰, Gerd R Burmester²¹, Gözde Kübra Yardımcı²², Jose A Gomez-Puerta^{23

24}, Julija Zepa^{25

26}, Lianne Kearsley-Fleet²⁷, Ludovic Trefond²⁸, Maria Cunha^{12

29}, Marta Mosca³⁰, Martina Cornalba³¹, Martin Soubrier³², Nicolas Roux³³, Olivier Brocq³⁴, Patrick Durez³⁵, Richard Conway³⁶, Tiphaine Goulenok³⁷, Johannes Wj Bijlsma³⁸, Iain B McInnes³⁹, Xavier Mariette⁴⁰

Affiliations

¹ Centre for Rheumatology & Department of Neuromuscular Diseases, University College London (UCL), London, UK p.machado@ucl.ac.uk.
² National Institute for Health Research (NIHR) University College London Hospitals Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK.
³ Department of Rheumatology, Northwick Park Hospital, London North West University Healthcare NHS Trust, London, UK.
⁴ Centre for Genetics and Genomics Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester, UK.
⁵ National Institute for Health Research (NIHR) Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
⁶ Epidemiology and Health Care Research, German Rheumatism Research Center (DRFZ Berlin), Berlin, Germany.
⁷ People with Arthritis/Rheumatism in Europe (PARE), European Alliance of Associations for Rheumatology (EULAR), Kilchberg, Switzerland.
⁸ Portuguese League Against Rheumatic Diseases (LPCDR), Lisbon, Portugal.
⁹ Institut Pierre Louis d'Epidémiologie et de Santé Publique, INSERM, Sorbonne Université, Paris, France.
¹⁰ Department of Rheumatology, Pitié-Salpêtrière hospital, AP-HP, Paris, France.
¹¹ Instituto de Salud Musculoesquelética, Madrid, Spain.
¹² Reuma.pt, Sociedade Portuguesa de Reumatologia, Lisbon, Portugal.
¹³ EpiDoC unit, CEDOC, Nova Medical School, Lisbon, Portugal.
¹⁴ Rheumatology Unit, Hospital dos Lusíadas, Lisbon, Portugal.
¹⁵ Department of Rheumatology, Central Hospital of Bolzano, Bolzano, Italy.
¹⁶ Department of Rheumatology, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
¹⁷ Coimbra Institute for Clinical and Biomedical Research, Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
¹⁸ Département de Médecine Interne et Immunologie Clinique, CHU Lille, Referral Center for Rare Systemic Autoimmune Diseases North and Northwest of France, INSERM U995, Lille Inflammation Research International Center (LIRIC), University of Lille, Lille, France.
¹⁹ Cabinet de Rhumatologie des "Marines de Chasles", Saint Malo, France.
²⁰ Department of Internal Medicine, Faculty Hospital Prešov, Prešov, Slovakia.
²¹ Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
²² Division of Rheumatology, Department of Internal Medicine, Hacettepe University School of Medicine, Ankara, Turkey.
²³ Department of Rheumaology, Hospital Clinic, Barcelona, Spain.
²⁴ University of Barcelona, Barcelona, Spain.
²⁵ Pauls Stradins Clinical University Hospital, Riga, Latvia.
²⁶ Riga Stradins University, Riga, Latvia.
²⁷ Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester, UK.
²⁸ Université Clermont Auvergne, CHU Clermont-Ferrand, Service de Médecine Interne, Hôpital Gabriel Montpied, INSERM U1071, Clermont-Ferrand, France.
²⁹ Hospital Garcia de Orta EPE, Almada, Setúbal, Portugal.
³⁰ University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
³¹ Dipartimento di Reumatologia e Scienze Mediche, ASST Gaetano Pini-CTO, Milan, Italy.
³² Department of Rheumatology, CHU Clermont-Ferrand, Hopital Gabriel Montpied, Clermont-Ferrand, France.
³³ Service de Rhumatologie, Hôpital Robert Schuman, Metz, France.
³⁴ Department of Rheumatology, Princess Grace Hospital, Monaco.
³⁵ University Hospital Saint-Luc, Brussels, Belgium.
³⁶ Department of Rheumatology, St. James's Hospital, Dublin, Ireland.
³⁷ Service de Médecine Interne, Hôpital Bichat-Claude Bernard, Assistance Publique Hôpitaux de Paris, Université de Paris, Paris, France.
³⁸ Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands.
³⁹ Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.
⁴⁰ Department of Rheumatology, Université Paris-Saclay, Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, INSERM UMR1184, Le Kremlin Bicêtre, Paris, France.

PMID: 34972811
DOI: 10.1136/annrheumdis-2021-221490

Free article

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 et al. Ann Rheum Dis. 2022 May.

Free article

. 2022 May;81(5):695-709.

doi: 10.1136/annrheumdis-2021-221490. Epub 2021 Dec 31.

Authors

Affiliations

¹ Centre for Rheumatology & Department of Neuromuscular Diseases, University College London (UCL), London, UK p.machado@ucl.ac.uk.
² National Institute for Health Research (NIHR) University College London Hospitals Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK.
³ Department of Rheumatology, Northwick Park Hospital, London North West University Healthcare NHS Trust, London, UK.
⁴ Centre for Genetics and Genomics Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester, UK.
⁵ National Institute for Health Research (NIHR) Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
⁶ Epidemiology and Health Care Research, German Rheumatism Research Center (DRFZ Berlin), Berlin, Germany.
⁷ People with Arthritis/Rheumatism in Europe (PARE), European Alliance of Associations for Rheumatology (EULAR), Kilchberg, Switzerland.
⁸ Portuguese League Against Rheumatic Diseases (LPCDR), Lisbon, Portugal.
⁹ Institut Pierre Louis d'Epidémiologie et de Santé Publique, INSERM, Sorbonne Université, Paris, France.
¹⁰ Department of Rheumatology, Pitié-Salpêtrière hospital, AP-HP, Paris, France.
¹¹ Instituto de Salud Musculoesquelética, Madrid, Spain.
¹² Reuma.pt, Sociedade Portuguesa de Reumatologia, Lisbon, Portugal.
¹³ EpiDoC unit, CEDOC, Nova Medical School, Lisbon, Portugal.
¹⁴ Rheumatology Unit, Hospital dos Lusíadas, Lisbon, Portugal.
¹⁵ Department of Rheumatology, Central Hospital of Bolzano, Bolzano, Italy.
¹⁶ Department of Rheumatology, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
¹⁷ Coimbra Institute for Clinical and Biomedical Research, Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
¹⁸ Département de Médecine Interne et Immunologie Clinique, CHU Lille, Referral Center for Rare Systemic Autoimmune Diseases North and Northwest of France, INSERM U995, Lille Inflammation Research International Center (LIRIC), University of Lille, Lille, France.
¹⁹ Cabinet de Rhumatologie des "Marines de Chasles", Saint Malo, France.
²⁰ Department of Internal Medicine, Faculty Hospital Prešov, Prešov, Slovakia.
²¹ Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
²² Division of Rheumatology, Department of Internal Medicine, Hacettepe University School of Medicine, Ankara, Turkey.
²³ Department of Rheumaology, Hospital Clinic, Barcelona, Spain.
²⁴ University of Barcelona, Barcelona, Spain.
²⁵ Pauls Stradins Clinical University Hospital, Riga, Latvia.
²⁶ Riga Stradins University, Riga, Latvia.
²⁷ Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester, UK.
²⁸ Université Clermont Auvergne, CHU Clermont-Ferrand, Service de Médecine Interne, Hôpital Gabriel Montpied, INSERM U1071, Clermont-Ferrand, France.
²⁹ Hospital Garcia de Orta EPE, Almada, Setúbal, Portugal.
³⁰ University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
³¹ Dipartimento di Reumatologia e Scienze Mediche, ASST Gaetano Pini-CTO, Milan, Italy.
³² Department of Rheumatology, CHU Clermont-Ferrand, Hopital Gabriel Montpied, Clermont-Ferrand, France.
³³ Service de Rhumatologie, Hôpital Robert Schuman, Metz, France.
³⁴ Department of Rheumatology, Princess Grace Hospital, Monaco.
³⁵ University Hospital Saint-Luc, Brussels, Belgium.
³⁶ Department of Rheumatology, St. James's Hospital, Dublin, Ireland.
³⁷ Service de Médecine Interne, Hôpital Bichat-Claude Bernard, Assistance Publique Hôpitaux de Paris, Université de Paris, Paris, France.
³⁸ Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands.
³⁹ Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.
⁴⁰ Department of Rheumatology, Université Paris-Saclay, Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, INSERM UMR1184, Le Kremlin Bicêtre, Paris, France.

PMID: 34972811
DOI: 10.1136/annrheumdis-2021-221490

Abstract

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.

Keywords: COVID-19; antirheumatic agents; autoimmune diseases; epidemiology; vaccination.

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Conflict of interest statement

Competing interests: PMM has received consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript, and is supported by the National Institute for Health Research (NIHR), University College London Hospitals (UCLH), Biomedical Research Centre. SL-T does not report conflicts of interest. AS has received personal fees from lectures for AbbVie, MSD, Lilly, Roche, BMS and Pfizer. EFM has received personal consultant fees from Boehringer Ingelheim Portugal, Lda; LPCDR received support for specific activities: grants from Abbvie, Novartis, Lilly Portugal, Amgen Biofarmacêutica, Grünenthal S.A., MSD, Medac and from A. Menarini Portugal - Farmacêutica, S.A.; grants and non-financial support from Pfizer, and non-financial support from Grünenthal GmbH, outside the submitted work. KLH has received non-personal speaker’s fees from Abbvie and grant income from BMS, UCB and Pfizer, all unrelated to this manuscript, and is supported by the NIHR Manchester Biomedical Research Centre. LG has received personal consultant fees from AbbVie, Amgen, BMS, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis and UCB, and grants from Amgen, Galapagos, Lilly, Pfizer, Sandoz and Sanofi, all unrelated to this manuscript. LC has not received any fees or personal grants from any laboratory, but her institute works by contract for laboratories among other institutions, such as Abbvie Spain, Eisai, Gebro Pharma, Merck Sharp & Dohme España, S.A., Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi Aventis, Astellas Pharma, Actelion Pharmaceuticals España, Grünenthal GmbH and UCB Pharma. AR has received research grants and consultant fees from Amgen and Pfizer, all unrelated to this manuscript. BR does not report conflicts of interest. CD does not report conflicts of interest. EH does not report conflicts of interest. EV reports personal consultant fees from Theramex, unrelated to this manuscript. ES does not report conflicts of interest. G-RRB reports personal consultant fees from AbbVie, Amgen, BMS, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sanofi-Aventis, UCB, all unrelated to this manuscript. GKY does not report conflicts of interest. JAG-P reports speaker fees from Abbvie, Astra-Zeneca, BMS, Galapagos, GSK, Janssen, Lilly, Novartis, Pfizer, Sanofi-Aventis and Roche, all unrelated to this manuscript. JZ reports speaker fees from Abbvie, Novartis, Janssen/Johnson & Johnson, all unrelated to this manuscript. LK-F does not report conflicts of interest. LT does not report conflicts of interest. MCu does not report conflicts of interest. MM does not report conflicts of interest. MCo does not report conflicts of interest. MS does not report conflicts of interest. NR does not report conflicts of interest. OB does not report conflicts of interest. PD does not report conflicts of interest. RC reports speaker’s fees from Janssen, Roche, Sanofi, Abbvie, all unrelated to this work. TG does not report conflicts of interest. JWJB does not report conflicts of interest. IM does not report conflicts of interest. XM reports personal consultant fees from BMS, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sanofi-Aventis, UCB and grant from Ose, all unrelated to this manuscript.

Comment in

Correspondence on "Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry" by Machado et al.
Bourguiba R, Delplanque M, Savey L, Hentgen V, Grateau G, Georgin-Lavialle S; French national reference Center for autoinflammatory diseases and AA amyloidosis (CEREMAIA). Bourguiba R, et al. Ann Rheum Dis. 2023 Dec;82(12):e228. doi: 10.1136/annrheumdis-2022-222118. Epub 2022 Jul 11. Ann Rheum Dis. 2023. PMID: 35817471 No abstract available.

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Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry

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Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry

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