TY - JOUR
T1 - Implementation and short-term adverse events of anti-SARS-CoV-2 vaccines in Inflammatory Bowel Disease patients
T2 - an international web-based survey
AU - Ellul, Pierre
AU - Revés, Joana
AU - Abreu, Bárbara
AU - Chaparro, María
AU - Gisbert, Javier P
AU - Allocca, Mariangela
AU - Fiorino, Gionata
AU - Barberio, Brigida
AU - Zingone, Fabiana
AU - Pisani, Anthea
AU - Cassar, David
AU - Michalopoulos, George
AU - Mantzaris, Gerassimos
AU - Koutroubakis, Ioannis
AU - Karmiris, Konstantinos
AU - Katsanos, Konstantinos
AU - Ďuricova, Dana
AU - Burisch, Johan
AU - Madsen, Gorm Roager
AU - Maaser, Christian
AU - Arebi, Naila
AU - Orfanoudaki, Eleni
AU - Milivojevic, Vladimir
AU - Buisson, Anthony
AU - Avedano, Luisa
AU - Leone, Salvo
AU - Torres, Joana
N1 - © The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: [email protected].
PY - 2022/8/4
Y1 - 2022/8/4
N2 - INTRODUCTION: Anti-SARS-CoV-2 vaccine clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease [IBD]. We aimed to describe the implementation of anti-SARS-CoV-2 vaccination among IBD patients, patients' concerns, and the side effect profile of the anti-SARS-CoV-2 vaccines, using real-world data.METHODS: An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of the patient characteristics, concerns, vaccination status, and side effect profile were analysed.RESULTS: In all 3272 IBD patients completed the survey, 79.6% had received at least one dose of anti-SARS-CoV-2 vaccine, and 71.7% had completed the vaccination process. Patients over 60 years old had a significantly higher rate of vaccination [p < 0.001]. Patients' main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD [24.6%], an IBD flare after vaccination [21.1%], and reduced vaccine efficacy due to IBD or associated immunosuppression [17.6%]. After the first dose of the vaccine, 72.4% had local symptoms and 51.4% had systemic symptoms [five patients had non-specified thrombosis]. Adverse events were less frequent after the second dose of the vaccine and in older patients. Only a minority of the patients were hospitalised [0.3%], needed a consultation [3.6%], or had to change IBD therapy [13.4%] after anti-SARS-CoV-2 vaccination.CONCLUSIONS: Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD.
AB - INTRODUCTION: Anti-SARS-CoV-2 vaccine clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease [IBD]. We aimed to describe the implementation of anti-SARS-CoV-2 vaccination among IBD patients, patients' concerns, and the side effect profile of the anti-SARS-CoV-2 vaccines, using real-world data.METHODS: An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of the patient characteristics, concerns, vaccination status, and side effect profile were analysed.RESULTS: In all 3272 IBD patients completed the survey, 79.6% had received at least one dose of anti-SARS-CoV-2 vaccine, and 71.7% had completed the vaccination process. Patients over 60 years old had a significantly higher rate of vaccination [p < 0.001]. Patients' main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD [24.6%], an IBD flare after vaccination [21.1%], and reduced vaccine efficacy due to IBD or associated immunosuppression [17.6%]. After the first dose of the vaccine, 72.4% had local symptoms and 51.4% had systemic symptoms [five patients had non-specified thrombosis]. Adverse events were less frequent after the second dose of the vaccine and in older patients. Only a minority of the patients were hospitalised [0.3%], needed a consultation [3.6%], or had to change IBD therapy [13.4%] after anti-SARS-CoV-2 vaccination.CONCLUSIONS: Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD.
KW - Inflammatory bowel disease
KW - COVID-19
KW - SARS-CoV-2
KW - vaccination
KW - Vaccination/adverse effects
KW - Europe
KW - Humans
KW - Middle Aged
KW - COVID-19/prevention & control
KW - Surveys and Questionnaires
KW - Aged
KW - COVID-19 Vaccines/adverse effects
KW - Internet
KW - Inflammatory Bowel Diseases/drug therapy
UR - http://www.scopus.com/inward/record.url?scp=85131819621&partnerID=8YFLogxK
U2 - 10.1093/ecco-jcc/jjac010
DO - 10.1093/ecco-jcc/jjac010
M3 - Journal article
C2 - 35037033
SN - 1873-9946
VL - 16
SP - 1070
EP - 1078
JO - Journal of Crohn's & colitis
JF - Journal of Crohn's & colitis
IS - 7
M1 - jjac010
ER -