tetano
Editor, Senior Moderator
Ann Rheum Dis
. 2021 Dec 31;annrheumdis-2021-221490.
doi: 10.1136/annrheumdis-2021-221490. Online ahead of print.
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[SUP] 1 2 3 [/SUP], Saskia Lawson-Tovey[SUP] 4 5 [/SUP], Anja Strangfeld[SUP] 6 [/SUP], Elsa F Mateus[SUP] 7 8 [/SUP], Kimme L Hyrich[SUP] 4 5 [/SUP], Laure Gossec[SUP] 9 10 [/SUP], Loreto Carmona[SUP] 11 [/SUP], Ana Rodrigues[SUP] 12 13 14 [/SUP], Bernd Raffeiner[SUP] 15 [/SUP], Catia Duarte[SUP] 12 16 17 [/SUP], Eric Hachulla[SUP] 18 [/SUP], Eric Veillard[SUP] 19 [/SUP], Eva Strakova[SUP] 20 [/SUP], Gerd R Burmester[SUP] 21 [/SUP], Gözde Kübra Yardımcı[SUP] 22 [/SUP], Jose A Gomez-Puerta[SUP] 23 24 [/SUP], Julija Zepa[SUP] 25 26 [/SUP], Lianne Kearsley-Fleet[SUP] 27 [/SUP], Ludovic Trefond[SUP] 28 [/SUP], Maria Cunha[SUP] 12 29 [/SUP], Marta Mosca[SUP] 30 [/SUP], Martina Cornalba[SUP] 31 [/SUP], Martin Soubrier[SUP] 32 [/SUP], Nicolas Roux[SUP] 33 [/SUP], Olivier Brocq[SUP] 34 [/SUP], Patrick Durez[SUP] 35 [/SUP], Richard Conway[SUP] 36 [/SUP], Tiphaine Goulenok[SUP] 37 [/SUP], Johannes Wj Bijlsma[SUP] 38 [/SUP], Iain B McInnes[SUP] 39 [/SUP], Xavier Mariette[SUP] 40 [/SUP]
Affiliations
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.
. 2021 Dec 31;annrheumdis-2021-221490.
doi: 10.1136/annrheumdis-2021-221490. Online ahead of print.
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[SUP] 1 2 3 [/SUP], Saskia Lawson-Tovey[SUP] 4 5 [/SUP], Anja Strangfeld[SUP] 6 [/SUP], Elsa F Mateus[SUP] 7 8 [/SUP], Kimme L Hyrich[SUP] 4 5 [/SUP], Laure Gossec[SUP] 9 10 [/SUP], Loreto Carmona[SUP] 11 [/SUP], Ana Rodrigues[SUP] 12 13 14 [/SUP], Bernd Raffeiner[SUP] 15 [/SUP], Catia Duarte[SUP] 12 16 17 [/SUP], Eric Hachulla[SUP] 18 [/SUP], Eric Veillard[SUP] 19 [/SUP], Eva Strakova[SUP] 20 [/SUP], Gerd R Burmester[SUP] 21 [/SUP], Gözde Kübra Yardımcı[SUP] 22 [/SUP], Jose A Gomez-Puerta[SUP] 23 24 [/SUP], Julija Zepa[SUP] 25 26 [/SUP], Lianne Kearsley-Fleet[SUP] 27 [/SUP], Ludovic Trefond[SUP] 28 [/SUP], Maria Cunha[SUP] 12 29 [/SUP], Marta Mosca[SUP] 30 [/SUP], Martina Cornalba[SUP] 31 [/SUP], Martin Soubrier[SUP] 32 [/SUP], Nicolas Roux[SUP] 33 [/SUP], Olivier Brocq[SUP] 34 [/SUP], Patrick Durez[SUP] 35 [/SUP], Richard Conway[SUP] 36 [/SUP], Tiphaine Goulenok[SUP] 37 [/SUP], Johannes Wj Bijlsma[SUP] 38 [/SUP], Iain B McInnes[SUP] 39 [/SUP], Xavier Mariette[SUP] 40 [/SUP]
Affiliations
- 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.