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Safety and efficacy of SARS-CoV-2 vaccination in 1237 patients with primary Sjögren syndrome


1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26
Collaborator/s: B. Xu1, X. Li2, T.A. Gheita3, A. Gattamelata4, A. Saraux5, M. Jezequel6, B. Nagy7, J. Sanchez-Guerrero8, S. Downie-Doyle9, C. Kirana10, G.M. Verstappen11, A. Vissink12, M. Akasbi13, R.A. Rojas14, A.M.F. Nafria15, A. Sisó-Almirall16

 

  1. Marmara University, School of Medicine, Istanbul, Turkey.
  2. Primary Care Centre Les Corts, Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE), Barcelona, Spain.
  3. Department of Internal Medicine and Medical Specialties, Rheumatology Clinic, Sapienza University of Rome, and Saint Camillus International University of Health Science, UniCamillus, Rome, Italy.
  4. Department of Autoimmune Diseases, ICMiD, Hospital Clínic, Barcelona, Spain, and Consejo Nacional de Ciencia y Tecnología (CONACYT), Mexico.
  5. Department of Life, Health & Environmental Sciences, University of L'Aquila and Internal Medicine and Nephrology Unit, Department of Medicine, ASL Avezzano-Sulmona-L'Aquila, San Salvatore Hospital, L'Aquila, Italy.
  6. Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, Hungary.
  7. Department of Medicine, Federal University of Espírito Santo, Vitória, Brazil.
  8. Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, the Netherlands.
  9. Department of Rheumatology, University Medical Centre, Ljubljana, Slovenia.
  10. Federal University of São Paulo, and Santo Amaro University, São Paulo, Brazil.
  11. Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
  12. Otorhinolaryngology, Head and Neck Surgery, Klinikum rechts der Isar, Technical University of Munich, Germany.
  13. Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina da Universidade de São Paulo, Brazil.
  14. Department of Internal Medicine, Hospital Universitari Joan XXIII, Tarragona, Spain.
  15. Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Italy.
  16. Department of Rheumatology, The Queen Elizabeth Hospital, Discipline of Medicine, University of Adelaide, SA, Australia.
  17. Department of Rheumatology, Centre Hospitalier Universitaire de la Cavale Blanche, Brest, France.
  18. Marmara University, School of Medicine, Istanbul, Turkey.
  19. Department of Internal Medicine and Medical Specialties, Rheumatology Clinic, Sapienza University of Rome, and Saint Camillus International University of Health Science, UniCamillus, Rome, Italy.
  20. Department of Life, Health & Environmental Sciences, University of L'Aquila and Internal Medicine and Nephrology Unit, Department of Medicine, ASL Avezzano-Sulmona-L'Aquila, San Salvatore Hospital, L'Aquila, Italy.
  21. Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, Hungary.
  22. Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, the Netherlands.
  23. Federal University of São Paulo, Brazil.
  24. Grup de Recerca Consolidat en la Síndrome de Sjögren (GRESS), Agència de Gestió d’Ajuts Universitaris i de Recerca (AGAUR), Generalitat de Catalunya, Spain.
  25. Department of Autoimmune Diseases, ICMiD, Hospital Clínic, Barcelona; Grup de Recerca Consolidat en la Síndrome de Sjögren (GRESS), Agència de Gestió d’Ajuts Universitaris i de Recerca (AGAUR), Generalitat de Catalunya, Spain; and Department of Medicine, University of Barcelona, Spain. mramos@clinic.cat
  26. Grup de Recerca Consolidat en la Síndrome de Sjögren (GRESS), Agència de Gestió d’Ajuts Universitaris i de Recerca (AGAUR), Generalitat de Catalunya, and Research and Innovation Group in Autoimmune Diseases, Sanitas Digital Hospital, Hospital-CIMA-Centre Mèdic Milenium Balmes Sanitas, Barcelona, Spain.

  1. Anhui provincial hospital (China)
  2. Anhui provincial hospital (China)
  3. Cairo University (Egypt)
  4. Department of Internal Medicine and Medical Specialties, Rheumatology Clinic, Sapienza University of Rome ( Italy)
  5. Cavale Blanche-University hospital (France)
  6. Cavale Blanche-University hospital (France)
  7. University of Debrecen (Hungary)
  8. Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (Mexico)
  9. The Queen Elizabeth Hospital, Adelaide (Australia)
  10. The Queen Elizabeth Hospital, Adelaide (Australia)
  11. Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen (the Netherlands)
  12. Department of Oral and Maxillofacial surgery, University of Groningen, University Medical Center Groningen, Groningen (the Netherlands)
  13. Department of Internal Medicine, Hospital Infanta Leonor, Madrid, Spain
  14. Hospital Universitari Joan XXIII, Tarragona, Spain
  15. Hospital Universitari Joan XXIII, Tarragona, Spain
  16. Primary Care Centre Les Corts, Consorci d’Atenció Primària de Salut Barcelona Esquerra (CAPSBE), Barcelona, Spain

on behalf of the Sjögren Big Data Consortium

CER15913
2022 Vol.40, N°12
PI 2290, PF 2297
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PMID: 36441656 [PubMed]

Received: 31/05/2022
Accepted : 02/08/2022
In Press: 17/11/2022
Published: 20/12/2022

Abstract

OBJECTIVES:
To investigate the safety and efficacy of SARS-Cov-2 vaccination in patients with primary Sjögren syndrome (pSS) due to scarcity of data in this population.
METHODS:
By the first week of May 2021, all Big Data SS Consortium centres patients who had received at least one dose of any SARS-CoV-2 vaccine were included in the study. The in-charge physician asked patients about local and systemic reactogenicity to collect SARS-CoV-2 vaccination data.
RESULTS:
The vaccination data of 1237 patients were received. A total of 835 patients (67%) reported any adverse events (AEs), including local (53%) and systemic (50%) AEs. Subjective symptoms (63%) were the most common local AEs, followed by objective signs at the injection site (16%), and general symptoms were the most commonly reported systemic AEs (46%), followed by musculoskeletal (25%), gastrointestinal (9%), cardiopulmonary (3%), and neurological (2%). In addition, 141 (11%) patients reported a significant worsening/exacerbation of their pre-vaccination sicca symptoms and fifteen (1.2%) patients reported active involvement in the glandular (n=7), articular (n=7), cutaneous (n=6), pulmonary (n=2), and peripheral nervous system (n=1) domains due to post-vaccination SS flares. In terms of vaccination efficacy, breakthrough SARS-CoV-2 infection was confirmed after vaccination in three (0.24 %) patients, and positive anti-SARS-Cov-2 antibodies were detected in approximately 95% of vaccinated SS patients, according to data available.
CONCLUSIONS:
Our data suggest that patients with pSS develop adequate humoral response and no severe AEs after SARS-CoV-2 vaccination and therefore raise no concerns about the vaccine’s efficacy or safety profile in this population.

DOI: https://doi.org/10.55563/clinexprheumatol/dt6klo

Rheumatology Article

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