PMID- 36047032
OWN - NLM
STAT- MEDLINE
DCOM- 20221031
LR  - 20221031
IS  - 1751-2441 (Electronic)
IS  - 1751-2433 (Linking)
VI  - 15
IP  - 10
DP  - 2022 Oct
TI  - BNT162b2 mRNA COVID-19 vaccine is safe in a setting of patients on biologic 
      therapy with inflammatory bowel diseases: a monocentric real-life study.
PG  - 1243-1252
LID - 10.1080/17512433.2022.2120466 [doi]
AB  - OBJECTIVES: Patients with inflammatory bowel disease were excluded from trials 
      that led to the approval of anti-COVID-19 vaccines and are worthy of real-life 
      studies providing information on the safety of these vaccines in this clinical 
      setting. METHODS: A prospective observational study was performed to estimate 
      BNT162b2 mRNA COVID-19 Vaccine local and systemic adverse events (AEs) incidence 
      related to administration in patients with inflammatory bowel disease through a 
      questionnaire administered at the first, second, and third doses. Disease 
      activity by Mayo Partial Score and Harvey-Bradshaw Index was also evaluated. 
      RESULTS: Eighty patients with a median age of 47.5 years were initially enrolled. 
      The local AEs rate was 26.25%, 58.75%, and 28.37% at the first, second, and third 
      doses of the vaccine, respectively. In contrast, the systemic AEs rate was 52.2%, 
      48.75%, and 43.24%. Clinic-demographic predictor variables for AEs were not 
      identified. Vaccination did not affect disease activity and no statistically 
      significant difference in disease activity index scores was observed between the 
      three doses. No serious adverse events were observed. CONCLUSION: This vaccine 
      was safe in a population of patients with inflammatory bowel disease and, 
      therefore, could be safely administered in this clinical setting.
FAU - Pellegrino, Raffaele
AU  - Pellegrino R
AUID- ORCID: 0000-0001-5074-230X
AD  - Department of Precision Medicine, University of Campania "Luigi Vanvitelli", 
      Naples, Italy.
FAU - Pellino, Gianluca
AU  - Pellino G
AUID- ORCID: 0000-0002-8322-6421
AD  - Department of Advanced Medical and Surgical Sciences, University of Campania 
      "Luigi Vanvitelli", Naples, Italy.
FAU - Selvaggi, Lucio
AU  - Selvaggi L
AD  - Department of Advanced Medical and Surgical Sciences, University of Campania 
      "Luigi Vanvitelli", Naples, Italy.
FAU - Selvaggi, Francesco
AU  - Selvaggi F
AUID- ORCID: 0000-0002-3219-3797
AD  - Department of Advanced Medical and Surgical Sciences, University of Campania 
      "Luigi Vanvitelli", Naples, Italy.
FAU - Federico, Alessandro
AU  - Federico A
AUID- ORCID: 0000-0002-0885-0793
AD  - Department of Precision Medicine, University of Campania "Luigi Vanvitelli", 
      Naples, Italy.
FAU - Romano, Marco
AU  - Romano M
AUID- ORCID: 0000-0002-3271-349X
AD  - Department of Precision Medicine, University of Campania "Luigi Vanvitelli", 
      Naples, Italy.
FAU - Gravina, Antonietta Gerarda
AU  - Gravina AG
AUID- ORCID: 0000-0001-8049-0115
AD  - Department of Precision Medicine, University of Campania "Luigi Vanvitelli", 
      Naples, Italy.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20220908
PL  - England
TA  - Expert Rev Clin Pharmacol
JT  - Expert review of clinical pharmacology
JID - 101278296
RN  - 0 (BNT162 Vaccine)
RN  - 0 (RNA, Messenger)
SB  - IM
MH  - Humans
MH  - Middle Aged
MH  - BNT162 Vaccine
MH  - RNA, Messenger
MH  - *COVID-19/prevention & control
MH  - *Inflammatory Bowel Diseases/drug therapy
MH  - Biological Therapy
OTO - NOTNLM
OT  - BNT162b2
OT  - COVID-19
OT  - IBD
OT  - SARS-Cov-2
OT  - crohn's disease
OT  - safety
OT  - ulcerative colitis
OT  - vaccine
EDAT- 2022/09/02 06:00
MHDA- 2022/11/01 06:00
CRDT- 2022/09/01 03:13
PHST- 2022/09/02 06:00 [pubmed]
PHST- 2022/11/01 06:00 [medline]
PHST- 2022/09/01 03:13 [entrez]
AID - 10.1080/17512433.2022.2120466 [doi]
PST - ppublish
SO  - Expert Rev Clin Pharmacol. 2022 Oct;15(10):1243-1252. doi: 
      10.1080/17512433.2022.2120466. Epub 2022 Sep 8.