Full Papers
Safety and efficacy of SARS-CoV-2 vaccination in 1237 patients with primary Sjögren syndrome
N. Inanc1, B. Kostov2, R. Priori3, A. Flores-Chavez4, F. Carubbi5, A. Szántó6, V. Valim7, H. Bootsma8, S. Praprotnik9, V. Fernandes Moça Trevisani10, G. Hernández-Molina11, B. Hofauer12, S.G. Pasoto13, M. López-Dupla14, E. Bartoloni15, M. Rischmueller16, V. Devauchelle-Pensec17, K. Abacar18, F. Giardina19, A. Alunno20, I. Fanny Horváth21, L. De Wolff22, L. Caldas23, S. Retamozo24, M. Ramos-Casals25, P. Brito-Zerón26
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
- Marmara University, School of Medicine, Istanbul, Turkey.
- Primary Care Centre Les Corts, Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE), Barcelona, Spain.
- Department of Internal Medicine and Medical Specialties, Rheumatology Clinic, Sapienza University of Rome, and Saint Camillus International University of Health Science, UniCamillus, Rome, Italy.
- Department of Autoimmune Diseases, ICMiD, Hospital Clínic, Barcelona, Spain, and Consejo Nacional de Ciencia y Tecnología (CONACYT), Mexico.
- 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.
- Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, Hungary.
- Department of Medicine, Federal University of Espírito Santo, Vitória, Brazil.
- Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, the Netherlands.
- Department of Rheumatology, University Medical Centre, Ljubljana, Slovenia.
- Federal University of São Paulo, and Santo Amaro University, São Paulo, Brazil.
- Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
- Otorhinolaryngology, Head and Neck Surgery, Klinikum rechts der Isar, Technical University of Munich, Germany.
- Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina da Universidade de São Paulo, Brazil.
- Department of Internal Medicine, Hospital Universitari Joan XXIII, Tarragona, Spain.
- Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Italy.
- Department of Rheumatology, The Queen Elizabeth Hospital, Discipline of Medicine, University of Adelaide, SA, Australia.
- Department of Rheumatology, Centre Hospitalier Universitaire de la Cavale Blanche, Brest, France.
- Marmara University, School of Medicine, Istanbul, Turkey.
- Department of Internal Medicine and Medical Specialties, Rheumatology Clinic, Sapienza University of Rome, and Saint Camillus International University of Health Science, UniCamillus, Rome, Italy.
- 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.
- Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, Hungary.
- Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, the Netherlands.
- Federal University of São Paulo, Brazil.
- Grup de Recerca Consolidat en la Síndrome de Sjögren (GRESS), Agència de Gestió d’Ajuts Universitaris i de Recerca (AGAUR), Generalitat de Catalunya, Spain.
- 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
- 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.
- Anhui provincial hospital (China)
- Anhui provincial hospital (China)
- Cairo University (Egypt)
- Department of Internal Medicine and Medical Specialties, Rheumatology Clinic, Sapienza University of Rome ( Italy)
- Cavale Blanche-University hospital (France)
- Cavale Blanche-University hospital (France)
- University of Debrecen (Hungary)
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (Mexico)
- The Queen Elizabeth Hospital, Adelaide (Australia)
- The Queen Elizabeth Hospital, Adelaide (Australia)
- Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen (the Netherlands)
- Department of Oral and Maxillofacial surgery, University of Groningen, University Medical Center Groningen, Groningen (the Netherlands)
- Department of Internal Medicine, Hospital Infanta Leonor, Madrid, Spain
- Hospital Universitari Joan XXIII, Tarragona, Spain
- Hospital Universitari Joan XXIII, Tarragona, Spain
- 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.