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Volume 11
Issue 3
10.3390/biomedicines11030687
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Article

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

by
Andrea Picchianti Diamanti
1,*,
Assunta Navarra
2,
Gilda Cuzzi
2,
Alessandra Aiello
2,
Simonetta Salemi
1,
Roberta Di Rosa
1,
Chiara De Lorenzo
1,
Daniele Vio
1,
Giandomenico Sebastiani
3,
Mario Ferraioli
4,
Maurizio Benucci
5,
Francesca Li Gobbi
5,
Fabrizio Cantini
6,
Vittoria Polidori
7,
Maurizio Simmaco
7,
Esmeralda Cialdi
7,
Palma Scolieri
8,
Vincenzo Bruzzese
8,
Emanuele Nicastri
9,
Raffaele D’Amelio
1,†,
Bruno Laganà
1 and
Delia Goletti
2add Show full author list remove Hide full author list
1
Department of Clinical and Molecular Medicine, Sapienza University of Rome, S. Andrea University Hospital, 00189 Rome, Italy
2
Translational Research Unit, National Institute for Infectious Diseases Lazzaro Spallanzani-IRCCS, 00161 Rome, Italy
3
Department of Rheumatology, San Camillo Hospital, 00152 Rome, Italy
4
Rheumatology, Allergology and Clinical Immunology, Department of ‘Medicina dei Sistemi’, University of Rome ‘Tor Vergata’, 00133 Rome, Italy
5
Rheumatology Unit, S. Giovanni di Dio Hospital, Azienda USL-Toscana Centro, 50122 Florence, Italy
6
Rheumatology Department, Hospital of Prato, 59100 Prato, Italy
7
UOC Laboratorio Analisi e Biochimica Clinica, Sant’Andrea University Hospital, 00189 Rome, Italy
8
UOC di Medicina e Rete Reumatologica, Ospedale Nuovo Regina Margherita, 00153 Rome, Italy
9
Clinical Division of Infectious Diseases, National Institute for Infectious Diseases Lazzaro Spallanzani-IRCCS, 00161 Rome, Italy
*
Author to whom correspondence should be addressed.
†
Retired.
Biomedicines 2023, 11(3), 687; https://doi.org/10.3390/biomedicines11030687
Submission received: 21 January 2023 / Revised: 15 February 2023 / Accepted: 21 February 2023 / Published: 23 February 2023
(This article belongs to the Special Issue Clinical Immunology in Italy, with Special Emphasis to Primary and Acquired Immunodeficiencies: A Commemorative Issue in Honor of Prof. Fernando Aiuti)
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Abstract

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.
Keywords: COVID-19; SARS-CoV-2 vaccine; immunogenicity; adverse events; disease flare; autoimmune rheumatic diseases COVID-19; SARS-CoV-2 vaccine; immunogenicity; adverse events; disease flare; autoimmune rheumatic diseases

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MDPI and ACS Style

Picchianti Diamanti, A.; Navarra, A.; Cuzzi, G.; Aiello, A.; Salemi, S.; Di Rosa, R.; De Lorenzo, C.; Vio, D.; Sebastiani, G.; Ferraioli, M.; et al. The Third Dose of BNT162b2 COVID-19 Vaccine Does Not “Boost” Disease Flares and Adverse Events in Patients with Rheumatoid Arthritis. Biomedicines 2023, 11, 687. https://doi.org/10.3390/biomedicines11030687

AMA Style

Picchianti Diamanti A, Navarra A, Cuzzi G, Aiello A, Salemi S, Di Rosa R, De Lorenzo C, Vio D, Sebastiani G, Ferraioli M, et al. The Third Dose of BNT162b2 COVID-19 Vaccine Does Not “Boost” Disease Flares and Adverse Events in Patients with Rheumatoid Arthritis. Biomedicines. 2023; 11(3):687. https://doi.org/10.3390/biomedicines11030687

Chicago/Turabian Style

Picchianti Diamanti, Andrea, Assunta Navarra, Gilda Cuzzi, Alessandra Aiello, Simonetta Salemi, Roberta Di Rosa, Chiara De Lorenzo, Daniele Vio, Giandomenico Sebastiani, Mario Ferraioli, and et al. 2023. "The Third Dose of BNT162b2 COVID-19 Vaccine Does Not “Boost” Disease Flares and Adverse Events in Patients with Rheumatoid Arthritis" Biomedicines 11, no. 3: 687. https://doi.org/10.3390/biomedicines11030687

APA Style

Picchianti Diamanti, A., Navarra, A., Cuzzi, G., Aiello, A., Salemi, S., Di Rosa, R., De Lorenzo, C., Vio, D., Sebastiani, G., Ferraioli, M., Benucci, M., Li Gobbi, F., Cantini, F., Polidori, V., Simmaco, M., Cialdi, E., Scolieri, P., Bruzzese, V., Nicastri, E., ... Goletti, D. (2023). The Third Dose of BNT162b2 COVID-19 Vaccine Does Not “Boost” Disease Flares and Adverse Events in Patients with Rheumatoid Arthritis. Biomedicines, 11(3), 687. https://doi.org/10.3390/biomedicines11030687

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