The Third Dose of BNT162b2 COVID-19 Vaccine Does Not 'Boost' Disease Flares and Adverse Events in Patients with Rheumatoid Arthritis

Autor: Andrea Picchianti Diamanti, Assunta Navarra, Gilda Cuzzi, Alessandra Aiello, Simonetta Salemi, Roberta Di Rosa, Chiara De Lorenzo, Daniele Vio, Giandomenico Sebastiani, Mario Ferraioli, Maurizio Benucci, Francesca Li Gobbi, Fabrizio Cantini, Vittoria Polidori, Maurizio Simmaco, Esmeralda Cialdi, Palma Scolieri, Vincenzo Bruzzese, Emanuele Nicastri, Raffaele D’Amelio, Bruno Laganà, Delia Goletti
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Biomedicines, Vol 11, Iss 3, p 687 (2023)
Druh dokumentu: article
ISSN: 2227-9059
DOI: 10.3390/biomedicines11030687
Popis: Data on the risk of adverse events (AEs) and disease flares in autoimmune rheumatic diseases (ARDs) after the third dose of COVID-19 vaccine are scarce. The aim of this multicenter, prospective study is to analyze the clinical and immunological safety of BNT162b2 vaccine in a cohort of rheumatoid arthritis (RA) patients followed-up from the first vaccine cycle to the third dose. The vaccine showed an overall good safety profile with no patient reporting serious AEs, and a low percentage of total AEs at both doses (40/78 (51.3%) and 13/47 (27.7%) patients after the second and third dose, respectively (p < 0.002). Flares were observed in 10.3% of patients after the end of the vaccination cycle and 12.8% after the third dose. Being vaccinated for influenza was inversely associated with the onset of AEs after the second dose, at both univariable (p = 0.013) and multivariable analysis (p = 0.027). This result could allow identification of a predictive factor of vaccine tolerance, if confirmed in larger patient populations. A higher disease activity at baseline was not associated with a higher incidence of AEs or disease flares. Effectiveness was excellent after the second dose, with only 1/78 (1.3%) mild breakthrough infection (BI) and worsened after the third dose, with 9/47 (19.2%) BI (p < 0.002), as a probable expression of the higher capacity of the Omicron variants to escape vaccine recognition.
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