Implementation and short-term adverse events of anti-SARS-CoV-2 vaccines in Inflammatory Bowel Disease patients: an international web-based survey

Pierre Ellul, Joana Revés, Bárbara Abreu, María Chaparro, Javier P Gisbert, Mariangela Allocca, Gionata Fiorino, Brigida Barberio, Fabiana Zingone, Anthea Pisani, David Cassar, George Michalopoulos, Gerassimos Mantzaris, Ioannis Koutroubakis, Konstantinos Karmiris, Konstantinos Katsanos, Dana Ďuricova, Johan Burisch, Gorm Roager Madsen, Christian MaaserNaila Arebi, Eleni Orfanoudaki, Vladimir Milivojevic, Anthony Buisson, Luisa Avedano, Salvo Leone, Joana Torres

Abstract

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.

OriginalsprogEngelsk
Artikelnummerjjac010
TidsskriftJournal of Crohn's & colitis
Vol/bind16
Udgave nummer7
Sider (fra-til)1070-1078
Antal sider9
ISSN1873-9946
DOI
StatusUdgivet - 4 aug. 2022

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