PMID- 36979666
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230331
IS  - 2227-9059 (Print)
IS  - 2227-9059 (Electronic)
IS  - 2227-9059 (Linking)
VI  - 11
IP  - 3
DP  - 2023 Feb 23
TI  - The Third Dose of BNT162b2 COVID-19 Vaccine Does Not "Boost" Disease Flares and 
      Adverse Events in Patients with Rheumatoid Arthritis.
LID - 10.3390/biomedicines11030687 [doi]
LID - 687
AB  - 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.
FAU - Picchianti Diamanti, Andrea
AU  - Picchianti Diamanti A
AUID- ORCID: 0000-0002-8552-4641
AD  - Department of Clinical and Molecular Medicine, Sapienza University of Rome, S. 
      Andrea University Hospital, 00189 Rome, Italy.
FAU - Navarra, Assunta
AU  - Navarra A
AUID- ORCID: 0000-0002-3662-4312
AD  - Translational Research Unit, National Institute for Infectious Diseases Lazzaro 
      Spallanzani-IRCCS, 00161 Rome, Italy.
FAU - Cuzzi, Gilda
AU  - Cuzzi G
AD  - Translational Research Unit, National Institute for Infectious Diseases Lazzaro 
      Spallanzani-IRCCS, 00161 Rome, Italy.
FAU - Aiello, Alessandra
AU  - Aiello A
AUID- ORCID: 0000-0003-2681-9383
AD  - Translational Research Unit, National Institute for Infectious Diseases Lazzaro 
      Spallanzani-IRCCS, 00161 Rome, Italy.
FAU - Salemi, Simonetta
AU  - Salemi S
AD  - Department of Clinical and Molecular Medicine, Sapienza University of Rome, S. 
      Andrea University Hospital, 00189 Rome, Italy.
FAU - Di Rosa, Roberta
AU  - Di Rosa R
AD  - Department of Clinical and Molecular Medicine, Sapienza University of Rome, S. 
      Andrea University Hospital, 00189 Rome, Italy.
FAU - De Lorenzo, Chiara
AU  - De Lorenzo C
AD  - Department of Clinical and Molecular Medicine, Sapienza University of Rome, S. 
      Andrea University Hospital, 00189 Rome, Italy.
FAU - Vio, Daniele
AU  - Vio D
AD  - Department of Clinical and Molecular Medicine, Sapienza University of Rome, S. 
      Andrea University Hospital, 00189 Rome, Italy.
FAU - Sebastiani, Giandomenico
AU  - Sebastiani G
AUID- ORCID: 0000-0003-2969-6649
AD  - Department of Rheumatology, San Camillo Hospital, 00152 Rome, Italy.
FAU - Ferraioli, Mario
AU  - Ferraioli M
AD  - Rheumatology, Allergology and Clinical Immunology, Department of 'Medicina dei 
      Sistemi', University of Rome 'Tor Vergata', 00133 Rome, Italy.
FAU - Benucci, Maurizio
AU  - Benucci M
AD  - Rheumatology Unit, S. Giovanni di Dio Hospital, Azienda USL-Toscana Centro, 50122 
      Florence, Italy.
FAU - Li Gobbi, Francesca
AU  - Li Gobbi F
AD  - Rheumatology Unit, S. Giovanni di Dio Hospital, Azienda USL-Toscana Centro, 50122 
      Florence, Italy.
FAU - Cantini, Fabrizio
AU  - Cantini F
AD  - Rheumatology Department, Hospital of Prato, 59100 Prato, Italy.
FAU - Polidori, Vittoria
AU  - Polidori V
AD  - UOC Laboratorio Analisi e Biochimica Clinica, Sant'Andrea University Hospital, 
      00189 Rome, Italy.
FAU - Simmaco, Maurizio
AU  - Simmaco M
AD  - UOC Laboratorio Analisi e Biochimica Clinica, Sant'Andrea University Hospital, 
      00189 Rome, Italy.
FAU - Cialdi, Esmeralda
AU  - Cialdi E
AD  - UOC Laboratorio Analisi e Biochimica Clinica, Sant'Andrea University Hospital, 
      00189 Rome, Italy.
FAU - Scolieri, Palma
AU  - Scolieri P
AUID- ORCID: 0000-0002-2055-7282
AD  - UOC di Medicina e Rete Reumatologica, Ospedale Nuovo Regina Margherita, 00153 
      Rome, Italy.
FAU - Bruzzese, Vincenzo
AU  - Bruzzese V
AD  - UOC di Medicina e Rete Reumatologica, Ospedale Nuovo Regina Margherita, 00153 
      Rome, Italy.
FAU - Nicastri, Emanuele
AU  - Nicastri E
AUID- ORCID: 0000-0002-5606-8712
AD  - Clinical Division of Infectious Diseases, National Institute for Infectious 
      Diseases Lazzaro Spallanzani-IRCCS, 00161 Rome, Italy.
FAU - D'Amelio, Raffaele
AU  - D'Amelio R
AUID- ORCID: 0000-0003-0669-2629
AD  - Department of Clinical and Molecular Medicine, Sapienza University of Rome, S. 
      Andrea University Hospital, 00189 Rome, Italy.
FAU - Lagana, Bruno
AU  - Lagana B
AUID- ORCID: 0000-0003-2305-4063
AD  - Department of Clinical and Molecular Medicine, Sapienza University of Rome, S. 
      Andrea University Hospital, 00189 Rome, Italy.
FAU - Goletti, Delia
AU  - Goletti D
AUID- ORCID: 0000-0001-8360-4376
AD  - Translational Research Unit, National Institute for Infectious Diseases Lazzaro 
      Spallanzani-IRCCS, 00161 Rome, Italy.
LA  - eng
GR  - 871029/Italian Ministry of Health, by the European Union's Horizon 2020 research 
      and innovation pro-gramme under EVA GLOBAL grant/
PT  - Journal Article
DEP - 20230223
PL  - Switzerland
TA  - Biomedicines
JT  - Biomedicines
JID - 101691304
PMC - PMC10045021
OTO - NOTNLM
OT  - COVID-19
OT  - SARS-CoV-2 vaccine
OT  - adverse events
OT  - autoimmune rheumatic diseases
OT  - disease flare
OT  - immunogenicity
COIS- The authors declare no conflict of interest.
EDAT- 2023/03/30 06:00
MHDA- 2023/03/30 06:01
PMCR- 2023/02/23
CRDT- 2023/03/29 01:20
PHST- 2023/01/21 00:00 [received]
PHST- 2023/02/15 00:00 [revised]
PHST- 2023/02/21 00:00 [accepted]
PHST- 2023/03/30 06:01 [medline]
PHST- 2023/03/29 01:20 [entrez]
PHST- 2023/03/30 06:00 [pubmed]
PHST- 2023/02/23 00:00 [pmc-release]
AID - biomedicines11030687 [pii]
AID - biomedicines-11-00687 [pii]
AID - 10.3390/biomedicines11030687 [doi]
PST - epublish
SO  - Biomedicines. 2023 Feb 23;11(3):687. doi: 10.3390/biomedicines11030687.