Real-World Use and Adverse Events of SARS-CoV-2 Vaccination in Greek Patients with Inflammatory Bowel Disease

Since inflammatory bowel disease (IBD) patients were excluded from vaccine authorization studies, limited knowledge exists regarding perceptions and unfavorable effects of COVID-19 vaccination in this group. We aimed to investigate the real-world use and adverse events (AEs) of COVID-19 vaccines in...

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Main Authors: Eleni Orfanoudaki, Eirini Zacharopoulou, Vassiliki Kitsou, Konstantinos Karmiris, Angeliki Theodoropoulou, Gerassimos J. Mantzaris, Maria Tzouvala, Spyridon Michopoulos, Evanthia Zampeli, Georgios Michalopoulos, Pantelis Karatzas, Nikos Viazis, Christos Liatsos, Giorgos Bamias, Ioannis E. Koutroubakis, on behalf of the Hellenic Group for the Study of IBD
Format: Article
Language:English
Published: MDPI AG 2022-01-01
Series:Journal of Clinical Medicine
Subjects:
Online Access:https://www.mdpi.com/2077-0383/11/3/641
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author Eleni Orfanoudaki
Eirini Zacharopoulou
Vassiliki Kitsou
Konstantinos Karmiris
Angeliki Theodoropoulou
Gerassimos J. Mantzaris
Maria Tzouvala
Spyridon Michopoulos
Evanthia Zampeli
Georgios Michalopoulos
Pantelis Karatzas
Nikos Viazis
Christos Liatsos
Giorgos Bamias
Ioannis E. Koutroubakis
on behalf of the Hellenic Group for the Study of IBD
author_facet Eleni Orfanoudaki
Eirini Zacharopoulou
Vassiliki Kitsou
Konstantinos Karmiris
Angeliki Theodoropoulou
Gerassimos J. Mantzaris
Maria Tzouvala
Spyridon Michopoulos
Evanthia Zampeli
Georgios Michalopoulos
Pantelis Karatzas
Nikos Viazis
Christos Liatsos
Giorgos Bamias
Ioannis E. Koutroubakis
on behalf of the Hellenic Group for the Study of IBD
author_sort Eleni Orfanoudaki
collection DOAJ
description Since inflammatory bowel disease (IBD) patients were excluded from vaccine authorization studies, limited knowledge exists regarding perceptions and unfavorable effects of COVID-19 vaccination in this group. We aimed to investigate the real-world use and adverse events (AEs) of COVID-19 vaccines in Greek IBD patients. Fully vaccinated IBD patients followed in Greek centers were invited to participate. All patients filled out an anonymous online survey concerning the vaccination program, which included information regarding demographics, clinical characteristics, treatment, vaccination perceptions and potential AEs. Overall, 1007 IBD patients were included. Vaccine hesitancy was reported by 49%. Total AEs to vaccination were reported by 81% after dose 1 (D1) and 76% after dose 2 (D2), including isolated injection site reactions (36% and 24% respectively). Systemic AEs were more common after D2 (51%, D2 vs. 44%, D1, <i>p</i> < 0.0001). Very few patients reported new onset abdominal symptoms (abdominal pain 4% (D1), 6% (D2) and diarrhea 5% (D1), 7% (D2)). There were no serious AEs leading to emergency room visit or hospitalization. In multivariate analysis, AEs occurrence was positively associated with young age and female gender (<i>p</i> < 0.0005 for both doses), whereas inactive disease was negatively associated with AE in D1 (<i>p</i> = 0.044). SARS-CoV-2 vaccination in Greek IBD patients demonstrated a favorable and reassuring safety profile.
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spelling doaj.art-f91eba554b314321b2ef6cfbcfd8ce942023-11-23T16:51:43ZengMDPI AGJournal of Clinical Medicine2077-03832022-01-0111364110.3390/jcm11030641Real-World Use and Adverse Events of SARS-CoV-2 Vaccination in Greek Patients with Inflammatory Bowel DiseaseEleni Orfanoudaki0Eirini Zacharopoulou1Vassiliki Kitsou2Konstantinos Karmiris3Angeliki Theodoropoulou4Gerassimos J. Mantzaris5Maria Tzouvala6Spyridon Michopoulos7Evanthia Zampeli8Georgios Michalopoulos9Pantelis Karatzas10Nikos Viazis11Christos Liatsos12Giorgos Bamias13Ioannis E. Koutroubakis14on behalf of the Hellenic Group for the Study of IBDDepartment of Gastroenterology, University Hospital of Heraklion, Medical School, University of Crete, 71110 Heraklion, GreeceDepartment of Gastroenterology, General Hospital of Nikaia Piraeus “Ag. Panteleimon”-General Hospital Dytikis Attikis “Agia Varvara”, 12351 Athens, GreeceGastroenterology Unit, 3rd Academic Department of Internal Medicine, National and Kapodistrian Univeristy of Athens, “Sotiria” General Hospital, 11527 Athens, GreeceDepartment of Gastroenterology, Venizelio General Hospital, 71409 Heraklion, GreeceDepartment of Gastroenterology, Venizelio General Hospital, 71409 Heraklion, GreeceDepartment of Gastroenterology, General Hospital of Athens, Evaggelismos-Polykliniki, 10676 Athens, GreeceDepartment of Gastroenterology, General Hospital of Nikaia Piraeus “Ag. Panteleimon”-General Hospital Dytikis Attikis “Agia Varvara”, 12351 Athens, GreeceDepartment of Gastroenterology, General Hospital of Athens “Alexandra”, 11528 Athens, GreeceDepartment of Gastroenterology, General Hospital of Athens “Alexandra”, 11528 Athens, GreeceDepartment of Gastroenterology, General Hospital of Piraeus “Tzaneio”, Piraeus, 18536 Athens, GreeceDepartment of Gastroenterology, National and Kapodistrian University of Athens, General Hospital of Athens “Laiko”, 11527 Athens, GreeceDepartment of Gastroenterology, General Hospital of Athens, Evaggelismos-Polykliniki, 10676 Athens, GreeceGastroenterology Department, 401 General Army Hospital of Athens, 11525 Athens, GreeceGastroenterology Unit, 3rd Academic Department of Internal Medicine, National and Kapodistrian Univeristy of Athens, “Sotiria” General Hospital, 11527 Athens, GreeceDepartment of Gastroenterology, University Hospital of Heraklion, Medical School, University of Crete, 71110 Heraklion, GreeceSince inflammatory bowel disease (IBD) patients were excluded from vaccine authorization studies, limited knowledge exists regarding perceptions and unfavorable effects of COVID-19 vaccination in this group. We aimed to investigate the real-world use and adverse events (AEs) of COVID-19 vaccines in Greek IBD patients. Fully vaccinated IBD patients followed in Greek centers were invited to participate. All patients filled out an anonymous online survey concerning the vaccination program, which included information regarding demographics, clinical characteristics, treatment, vaccination perceptions and potential AEs. Overall, 1007 IBD patients were included. Vaccine hesitancy was reported by 49%. Total AEs to vaccination were reported by 81% after dose 1 (D1) and 76% after dose 2 (D2), including isolated injection site reactions (36% and 24% respectively). Systemic AEs were more common after D2 (51%, D2 vs. 44%, D1, <i>p</i> < 0.0001). Very few patients reported new onset abdominal symptoms (abdominal pain 4% (D1), 6% (D2) and diarrhea 5% (D1), 7% (D2)). There were no serious AEs leading to emergency room visit or hospitalization. In multivariate analysis, AEs occurrence was positively associated with young age and female gender (<i>p</i> < 0.0005 for both doses), whereas inactive disease was negatively associated with AE in D1 (<i>p</i> = 0.044). SARS-CoV-2 vaccination in Greek IBD patients demonstrated a favorable and reassuring safety profile.https://www.mdpi.com/2077-0383/11/3/641COVID-19Crohn’s diseasevaccineulcerative colitis
spellingShingle Eleni Orfanoudaki
Eirini Zacharopoulou
Vassiliki Kitsou
Konstantinos Karmiris
Angeliki Theodoropoulou
Gerassimos J. Mantzaris
Maria Tzouvala
Spyridon Michopoulos
Evanthia Zampeli
Georgios Michalopoulos
Pantelis Karatzas
Nikos Viazis
Christos Liatsos
Giorgos Bamias
Ioannis E. Koutroubakis
on behalf of the Hellenic Group for the Study of IBD
Real-World Use and Adverse Events of SARS-CoV-2 Vaccination in Greek Patients with Inflammatory Bowel Disease
Journal of Clinical Medicine
COVID-19
Crohn’s disease
vaccine
ulcerative colitis
title Real-World Use and Adverse Events of SARS-CoV-2 Vaccination in Greek Patients with Inflammatory Bowel Disease
title_full Real-World Use and Adverse Events of SARS-CoV-2 Vaccination in Greek Patients with Inflammatory Bowel Disease
title_fullStr Real-World Use and Adverse Events of SARS-CoV-2 Vaccination in Greek Patients with Inflammatory Bowel Disease
title_full_unstemmed Real-World Use and Adverse Events of SARS-CoV-2 Vaccination in Greek Patients with Inflammatory Bowel Disease
title_short Real-World Use and Adverse Events of SARS-CoV-2 Vaccination in Greek Patients with Inflammatory Bowel Disease
title_sort real world use and adverse events of sars cov 2 vaccination in greek patients with inflammatory bowel disease
topic COVID-19
Crohn’s disease
vaccine
ulcerative colitis
url https://www.mdpi.com/2077-0383/11/3/641
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