PMID- 34972811
OWN - NLM
STAT- MEDLINE
DCOM- 20220412
LR  - 20231119
IS  - 1468-2060 (Electronic)
IS  - 0003-4967 (Linking)
VI  - 81
IP  - 5
DP  - 2022 May
TI  - Safety of vaccination against SARS-CoV-2 in people with rheumatic and 
      musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) 
      physician-reported registry.
PG  - 695-709
LID - 10.1136/annrheumdis-2021-221490 [doi]
AB  - 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.
CI  - (c) Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and 
      permissions. Published by BMJ.
FAU - Machado, Pedro M
AU  - Machado PM
AUID- ORCID: 0000-0002-8411-7972
AD  - Centre for Rheumatology & Department of Neuromuscular Diseases, University 
      College London (UCL), London, UK p.machado@ucl.ac.uk.
AD  - National Institute for Health Research (NIHR) University College London Hospitals 
      Biomedical Research Centre, University College London Hospitals NHS Foundation 
      Trust, London, UK.
AD  - Department of Rheumatology, Northwick Park Hospital, London North West University 
      Healthcare NHS Trust, London, UK.
FAU - Lawson-Tovey, Saskia
AU  - Lawson-Tovey S
AUID- ORCID: 0000-0002-8611-162X
AD  - Centre for Genetics and Genomics Versus Arthritis, Centre for Musculoskeletal 
      Research, University of Manchester, Manchester, UK.
AD  - National Institute for Health Research (NIHR) Manchester Biomedical Research 
      Centre, Manchester University NHS Foundation Trust, Manchester Academic Health 
      Science Centre, Manchester, UK.
FAU - Strangfeld, Anja
AU  - Strangfeld A
AUID- ORCID: 0000-0002-6233-022X
AD  - Epidemiology and Health Care Research, German Rheumatism Research Center (DRFZ 
      Berlin), Berlin, Germany.
FAU - Mateus, Elsa F
AU  - Mateus EF
AUID- ORCID: 0000-0003-0059-2141
AD  - People with Arthritis/Rheumatism in Europe (PARE), European Alliance of 
      Associations for Rheumatology (EULAR), Kilchberg, Switzerland.
AD  - Portuguese League Against Rheumatic Diseases (LPCDR), Lisbon, Portugal.
FAU - Hyrich, Kimme L
AU  - Hyrich KL
AUID- ORCID: 0000-0001-8242-9262
AD  - Centre for Genetics and Genomics Versus Arthritis, Centre for Musculoskeletal 
      Research, University of Manchester, Manchester, UK.
AD  - National Institute for Health Research (NIHR) Manchester Biomedical Research 
      Centre, Manchester University NHS Foundation Trust, Manchester Academic Health 
      Science Centre, Manchester, UK.
FAU - Gossec, Laure
AU  - Gossec L
AUID- ORCID: 0000-0002-4528-310X
AD  - Institut Pierre Louis d'Epidemiologie et de Sante Publique, INSERM, Sorbonne 
      Universite, Paris, France.
AD  - Department of Rheumatology, Pitie-Salpetriere hospital, AP-HP, Paris, France.
FAU - Carmona, Loreto
AU  - Carmona L
AUID- ORCID: 0000-0002-4401-2551
AD  - Instituto de Salud Musculoesqueletica, Madrid, Spain.
FAU - Rodrigues, Ana
AU  - Rodrigues A
AD  - Reuma.pt, Sociedade Portuguesa de Reumatologia, Lisbon, Portugal.
AD  - EpiDoC unit, CEDOC, Nova Medical School, Lisbon, Portugal.
AD  - Rheumatology Unit, Hospital dos Lusiadas, Lisbon, Portugal.
FAU - Raffeiner, Bernd
AU  - Raffeiner B
AUID- ORCID: 0000-0002-7719-1736
AD  - Department of Rheumatology, Central Hospital of Bolzano, Bolzano, Italy.
FAU - Duarte, Catia
AU  - Duarte C
AUID- ORCID: 0000-0001-9327-6935
AD  - Reuma.pt, Sociedade Portuguesa de Reumatologia, Lisbon, Portugal.
AD  - Department of Rheumatology, Centro Hospitalar e Universitario de Coimbra, 
      Coimbra, Portugal.
AD  - Coimbra Institute for Clinical and Biomedical Research, Faculty of Medicine, 
      University of Coimbra, Coimbra, Portugal.
FAU - Hachulla, Eric
AU  - Hachulla E
AUID- ORCID: 0000-0001-7432-847X
AD  - Departement de Medecine 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.
FAU - Veillard, Eric
AU  - Veillard E
AD  - Cabinet de Rhumatologie des "Marines de Chasles", Saint Malo, France.
FAU - Strakova, Eva
AU  - Strakova E
AD  - Department of Internal Medicine, Faculty Hospital Presov, Presov, Slovakia.
FAU - Burmester, Gerd R
AU  - Burmester GR
AUID- ORCID: 0000-0001-7518-1131
AD  - Department of Rheumatology and Clinical Immunology, Charite - Universitatsmedizin 
      Berlin, Berlin, Germany.
FAU - Yardimci, Gozde Kubra
AU  - Yardimci GK
AD  - Division of Rheumatology, Department of Internal Medicine, Hacettepe University 
      School of Medicine, Ankara, Turkey.
FAU - Gomez-Puerta, Jose A
AU  - Gomez-Puerta JA
AUID- ORCID: 0000-0001-8177-702X
AD  - Department of Rheumaology, Hospital Clinic, Barcelona, Spain.
AD  - University of Barcelona, Barcelona, Spain.
FAU - Zepa, Julija
AU  - Zepa J
AD  - Pauls Stradins Clinical University Hospital, Riga, Latvia.
AD  - Riga Stradins University, Riga, Latvia.
FAU - Kearsley-Fleet, Lianne
AU  - Kearsley-Fleet L
AUID- ORCID: 0000-0003-0377-1575
AD  - Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, 
      University of Manchester, Manchester, UK.
FAU - Trefond, Ludovic
AU  - Trefond L
AUID- ORCID: 0000-0001-5454-903X
AD  - Universite Clermont Auvergne, CHU Clermont-Ferrand, Service de Medecine Interne, 
      Hopital Gabriel Montpied, INSERM U1071, Clermont-Ferrand, France.
FAU - Cunha, Maria
AU  - Cunha M
AD  - Reuma.pt, Sociedade Portuguesa de Reumatologia, Lisbon, Portugal.
AD  - Hospital Garcia de Orta EPE, Almada, Setubal, Portugal.
FAU - Mosca, Marta
AU  - Mosca M
AD  - University of Pisa and Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
FAU - Cornalba, Martina
AU  - Cornalba M
AD  - Dipartimento di Reumatologia e Scienze Mediche, ASST Gaetano Pini-CTO, Milan, 
      Italy.
FAU - Soubrier, Martin
AU  - Soubrier M
AD  - Department of Rheumatology, CHU Clermont-Ferrand, Hopital Gabriel Montpied, 
      Clermont-Ferrand, France.
FAU - Roux, Nicolas
AU  - Roux N
AD  - Service de Rhumatologie, Hopital Robert Schuman, Metz, France.
FAU - Brocq, Olivier
AU  - Brocq O
AD  - Department of Rheumatology, Princess Grace Hospital, Monaco.
FAU - Durez, Patrick
AU  - Durez P
AUID- ORCID: 0000-0002-7156-2356
AD  - University Hospital Saint-Luc, Brussels, Belgium.
FAU - Conway, Richard
AU  - Conway R
AUID- ORCID: 0000-0003-2538-3362
AD  - Department of Rheumatology, St. James's Hospital, Dublin, Ireland.
FAU - Goulenok, Tiphaine
AU  - Goulenok T
AD  - Service de Medecine Interne, Hopital Bichat-Claude Bernard, Assistance Publique 
      Hopitaux de Paris, Universite de Paris, Paris, France.
FAU - Bijlsma, Johannes Wj
AU  - Bijlsma JW
AUID- ORCID: 0000-0002-0128-8451
AD  - Department of Rheumatology and Clinical Immunology, University Medical Center 
      Utrecht, Utrecht, Netherlands.
FAU - McInnes, Iain B
AU  - McInnes IB
AD  - Institute of Infection, Immunity and Inflammation, University of Glasgow, 
      Glasgow, UK.
FAU - Mariette, Xavier
AU  - Mariette X
AUID- ORCID: 0000-0002-4244-5417
AD  - Department of Rheumatology, Universite Paris-Saclay, Assistance Publique-Hopitaux 
      de Paris, Hopital Bicetre, INSERM UMR1184, Le Kremlin Bicetre, Paris, France.
LA  - eng
PT  - Journal Article
DEP - 20211231
PL  - England
TA  - Ann Rheum Dis
JT  - Annals of the rheumatic diseases
JID - 0372355
RN  - 0 (Antirheumatic Agents)
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Immunosuppressive Agents)
RN  - Rippling muscle disease, 1
SB  - IM
CIN - Ann Rheum Dis. 2023 Dec;82(12):e228. PMID: 35817471
MH  - Aged
MH  - *Antirheumatic Agents/adverse effects
MH  - *COVID-19/epidemiology/prevention & control
MH  - COVID-19 Vaccines/adverse effects
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Muscular Diseases
MH  - *Musculoskeletal Diseases/chemically induced/drug therapy/epidemiology
MH  - Registries
MH  - *Rheumatic Diseases/drug therapy
MH  - Rheumatologists
MH  - SARS-CoV-2
MH  - Vaccination/adverse effects
OTO - NOTNLM
OT  - COVID-19
OT  - antirheumatic agents
OT  - autoimmune diseases
OT  - epidemiology
OT  - vaccination
COIS- 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 Biofarmaceutica, Grunenthal S.A., MSD, 
      Medac and from A. Menarini Portugal - Farmaceutica, S.A.; grants and 
      non-financial support from Pfizer, and non-financial support from Grunenthal 
      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 Espana, S.A., Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi Aventis, 
      Astellas Pharma, Actelion Pharmaceuticals Espana, Grunenthal 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.
EDAT- 2022/01/02 06:00
MHDA- 2022/04/13 06:00
CRDT- 2022/01/01 05:19
PHST- 2021/09/10 00:00 [received]
PHST- 2021/12/08 00:00 [accepted]
PHST- 2022/01/02 06:00 [pubmed]
PHST- 2022/04/13 06:00 [medline]
PHST- 2022/01/01 05:19 [entrez]
AID - annrheumdis-2021-221490 [pii]
AID - 10.1136/annrheumdis-2021-221490 [doi]
PST - ppublish
SO  - Ann Rheum Dis. 2022 May;81(5):695-709. doi: 10.1136/annrheumdis-2021-221490. Epub 
      2021 Dec 31.