Artigo Acesso aberto Produção Nacional Revisado por pares

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

2022; Springer Vienna; Linguagem: Inglês

10.55563/clinexprheumatol/dt6klo

ISSN

1593-098X

Autores

Nevsun İnanç, Belchin Kostov, Roberta Priori, Alejandra Flores-Chávez, Francesco Carubbi, Antónia Szántó, Valéria Valim, Hendrika Bootsma, Sonja Praprotnik, Virgínia Fernandes Moça Trevisani, Gabriela Hernández‐Molina, Benedikt Hofauer, Sandra Gofinet Pasoto, Miguel López-Dupla, Elena Bartoloni, Maureen Rischmueller, Valérie Devauchelle‐Pensec, K. Abacar, Federico Giardina, Alessia Alunno, Ildikó Fanny Horváth, Liseth de Wolff, Laura Passos Caldas, Soledad Retamozo, Manuel Ramos‐Casals, Pilar Brito‐Zerón,

Tópico(s)

Systemic Lupus Erythematosus Research

Resumo

ObjectiveTo 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-2vaccine were included in the study.The in-charge physician asked patients about local and systemic reactogenicity to collect SARS-CoV-2 vaccination data. ResultsThe 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. ConclusionOur 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.

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