Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Effectiveness and Safety of the COVID-19 Vaccine in Patients With Rheumatoid Arthritis in a Real-World Setting

María Torres-Rufas
,
Esther F. Vicente-Rabaneda
* ORCID logo ,
Laura Cardeñoso
,
Ainhoa Gutiérrez-Cobos
,
Cristina Valero-Martínez
ORCID logo ,
José M. Serra López-Matencio
ORCID logo ,
Rosario García-Vicuña
ORCID logo ,
Miguel A. González-Gay
ORCID logo ,
Isidoro González-Álvaro
ORCID logo ,
Santos Castañeda
* ORCID logo
Version 1 : Received: 9 January 2024 / Approved: 9 January 2024 / Online: 9 January 2024 (07:37:38 CET)

How to cite: Torres-Rufas, M.; Vicente-Rabaneda, E.F.; Cardeñoso, L.; Gutiérrez-Cobos, A.; Valero-Martínez, C.; López-Matencio, J.M.S.; García-Vicuña, R.; González-Gay, M.A.; González-Álvaro, I.; Castañeda, S. Effectiveness and Safety of the COVID-19 Vaccine in Patients With Rheumatoid Arthritis in a Real-World Setting. Preprints 2024, 2024010703. https://doi.org/10.20944/preprints202401.0703.v1 Torres-Rufas, M.; Vicente-Rabaneda, E.F.; Cardeñoso, L.; Gutiérrez-Cobos, A.; Valero-Martínez, C.; López-Matencio, J.M.S.; García-Vicuña, R.; González-Gay, M.A.; González-Álvaro, I.; Castañeda, S. Effectiveness and Safety of the COVID-19 Vaccine in Patients With Rheumatoid Arthritis in a Real-World Setting. Preprints 2024, 2024010703. https://doi.org/10.20944/preprints202401.0703.v1

Abstract

Background: To describe the effectiveness and safety of COVID-19 vaccine in a series of patients with rheumatoid arthritis (RA). Methods: Retrospective single-center study of RA patients, fulfilling the ACR 1987 or ACR/EULAR 2010 classification criteria, that received first COVID-19 vaccine between December 2020 and October 2021, had post-vaccination serology and subsequent follow-up of at least 6 months in a university hospital. Vaccine effectiveness was evaluated by the serological response and the incidence of post-vaccine COVID-19, and safety by the incidence of adverse events (AE) and RA flares. Adjusted logistic and linear multivariate regression analyses were carried out with Stata® to identify factors associated with vaccine response. Results: We included 118 patients with RA (87.2% women, age 65.4±11.6 years, evolution 12.0±9.6 years). 95.8% received complete vaccination schedule. Most patients (88.1%) developed adequate humoral immunogenicity, and the degree of serological response was significantly related to younger age and previous COVID-19 infection. After vaccination, 18.6% presented mild SARS-CoV-2 infection. Vaccine AE (19.5%) were mostly mild and inversely associated with age (OR 0.95). RA flares were anecdotal (1.7%) and inversely related to age (OR 0.95). Conclusion: Our results suggest that COVID-19 vaccine induces adequate humoral immunogenicity, with an acceptable safety profile in RA patients.

Keywords

Rheumatoid arthritis; COVID-19 vaccine; humoral response; effectiveness; safety

Subject

Medicine and Pharmacology, Medicine and Pharmacology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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