P641 Implementation and short-term adverse events of anti-SARS-CoV-2 vaccines in Inflammatory Bowel Disease patients: an international web-based survey
Revés, J.(1);Abreu, B.(1);Chaparro, M.(2);Gisbert, J.P.(2);Mariangela, A.(3);Fiorino, G.(3);Barberio, B.(4);Zingone, F.(4);Pisani, A.(5);Cassar, D.(5);Michalopoulos, G.(6);Mantzaris, G.(7);Mountaki, K.(7);Koutroubakis, I.(8);Karmiris, K.(9);Katsanos, K.(10);Ďuricova, D.(11);Burisch, J.(12);Madsen, G.R.(12);Maaser, C.(13);Naila, A.(14);Orfanoudaki, E.(8);Milivojevic, V.(15);Buisson, A.(16);Avedano, L.(17);Leone, S.(18);Torres, J.(1);Ellul, P.(5);
(1)Hospital Beatriz Ângelo, Gastrenterology Department, Loures, Portugal;(2)Hospital Universitario de La Princesa- Instituto de Investigación Sanitaria Princesa IIS-IP- Universidad Autónoma de Madrid UAM- and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBEREHD, Gastrenterology Unit, Madrid, Spain;(3)IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Gastrenterology and Endoscopy, Milan, Italy;(4)University of Padova, Department of Surgery- Oncology and Gastroenterology DiSCOG- Gastroenterology Unit, Padova, Italy;(5)Mater Dei Hospital, Division of Gastrenterology, Msida, Malta;(6)Tzaneion General Hospital of Piraeus, Gastrenterology Department, Piraeus, Greece;(7)Ophthalmiatreion Athinon and Polyclinic Hospitals, Evangelismos, Athens, Greece;(8)University Hospital of Heraklion, Gastrenterology Department, Heraklion, Greece;(9)Venizeleio General Hospital, Gastrenterology Department, Heraklion, Greece;(10)University and Medical School of Ioannina, Gastrenterology Department, Ioannina, Greece;(11)ISCARE, IBD Clinical and Research Centre, Prague, Czech Republic;(12)Hvidovre Hospital- University of Copenhagen, Gastrounit- medical division, Hvidovre, Denmark;(13)Hospital Lüneburg, Gastrenterology Department, Lüneburg, Germany;(14)St Mark's National Bowel Hospital, IBD Department, London, United Kingdom;(15)Clinical center of Serbia- School of Medicine, Clinic for gastroenterology and hepatology, Belgrade, Serbia;(16)Université Clermont Auvergne- Inserm- U1071- M2iSH- USC-INRA 2018 3iHP- CHU Clermont-Ferrand, Service d'Hépato-Gastroentérologie, Clermont-Ferrand, France;(17)European Federation of Crohn's and Ulcerative Colitis Associations, efcca, Brussels, Belgium;(18)European Federation of Crohn's and Ulcerative Colitis Associations, effca, Brussels, Belgium;
Pivotal anti-SARS-CoV-2 vaccines 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 vaccines among IBD patients, patients’ concerns before vaccination and side-effect profile of the anti-SARS-CoV-2 vaccines using real-world data.
An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of patients’ characteristics, concerns, vaccination status and side-effect profile were analysed using descriptive statistics and logistic regression.
Among the 3272 IBD patients completing the survey (0.1% of the IBD European population), 79.6% had received at least one dose of the anti-SARS-CoV-2 vaccine, and 71.7% had completed the vaccination process. Most of the patients (70.6%) were vaccinated with the Pfizer-BioNTech (BNT162b2) vaccine. Patients over 60 years old had a significantly higher rate of vaccination (OR 2.98, 95% CI 2.20-4.03, p<0.001). Patients’ main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD (24.6%), having 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 at the injection site and 51.4% had systemic symptoms (5 patients had non-specified thrombosis). Adverse events were less frequent after the second dose of the vaccine and in older patients. When comparing with previous studies from the general population, the IBD patients answering the survey did not seem to have increased side effects (Table 1). Only a minority of the patients were hospitalized (0.3%), needed a consultation (3.6%) or had to change IBD therapy (13.4%) after anti-SARS-CoV-2 vaccination.
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.