Abstract
Introduction
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 vaccination among IBD patients, patients’ concerns and 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
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 (5 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 hospitalized (0.3%), needed a consultation (3.6%) or had to change IBD therapy (13.4%) after anti-SARS-CoV-2 vaccination.
Conclusion
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.
Keywords: Inflammatory Bowel Disease, COVID-19, SARS-CoV-2, vaccination
Contributor Information
Pierre Ellul, Division of Gastroenterology Mater Dei Hospital, Msida, Malta.
Joana Revés, Gastroenterology Division, Surgical Department, Hospital Beatriz Ângelo, Loures, Portugal.
Bárbara Abreu, Gastroenterology Division, Surgical Department, Hospital Beatriz Ângelo, Loures, Portugal.
María Chaparro, Gastroenterology Unit, 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), Madrid, Spain.
Javier P Gisbert, Gastroenterology Unit, 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), Madrid, Spain.
Mariangela Allocca, IBD Center, Humanitas Clinical and Research Center, Milan, Italy; Department of Surgery, Oncology and Gastroenterology (DiSCOG), Gastroenterology Unit, University of Padova, Padova, Italy.
Gionata Fiorino, IBD Center, Humanitas Clinical and Research Center, Milan, Italy; Department of Surgery, Oncology and Gastroenterology (DiSCOG), Gastroenterology Unit, University of Padova, Padova, Italy.
Brigida Barberio, IBD Center, Humanitas Clinical and Research Center, Milan, Italy; Department of Surgery, Oncology and Gastroenterology (DiSCOG), Gastroenterology Unit, University of Padova, Padova, Italy.
Fabiana Zingone, IBD Center, Humanitas Clinical and Research Center, Milan, Italy; Department of Surgery, Oncology and Gastroenterology (DiSCOG), Gastroenterology Unit, University of Padova, Padova, Italy.
Anthea Pisani, Division of Gastroenterology Mater Dei Hospital, Msida, Malta.
David Cassar, Division of Gastroenterology Mater Dei Hospital, Msida, Malta.
George Michalopoulos, Gastroenterology Department Tzaneion General Hospital of Piraeus, Greece.
Gerassimos Mantzaris, Evangelismos, Ophthalmiatreion Athinon and Polyclinic Hospitals, Athens, Greece.
Ioannis Koutroubakis, University Hospital of Heraklion, Heraklion, Greece.
Konstantinos Karmiris, Venizeleio General Hospital, Heraklion, Crete, Greece.
Konstantinos Katsanos, University and Medical School of Ioannina, Ioannina, Greece.
Dana Ďuricova, IBD Clinical and Research Centre, ISCARE, Prague, Czech Republic; Institute of Pharmacology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.
Johan Burisch, Gastrounit, medical division, Hvidovre Hospital, University of Copenhagen Hvidovre, Denmark; Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, University of Copenhagen Hvidovre, Denmark.
Gorm Roager Madsen, Gastrounit, medical division, Hvidovre Hospital, University of Copenhagen Hvidovre, Denmark; Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, University of Copenhagen Hvidovre, Denmark.
Christian Maaser, Hospital Lüneburg, Lüneburg, Germany.
Naila Arebi, St Mark's National Bowel Hospital, London, UK.
Eleni Orfanoudaki, University Hospital of Heraklion, Heraklion, Greece.
Vladimir Milivojevic, Clinic for gastroenterology and hepatology, Clinical center of Serbia, School of Medicine, Belgrade, Serbia.
Anthony Buisson, Université Clermont Auvergne, Inserm, CHU Clermont-Ferrand, 3iHP, Service d’Hépato-Gastro Entérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Clermont-Ferrand, France.
Luisa Avedano, The European Federation of Crohn's & Ulcerative Colitis Associations (EFCCA).
Salvo Leone, The European Federation of Crohn's & Ulcerative Colitis Associations (EFCCA).
Joana Torres, Gastroenterology Division, Surgical Department, Hospital Beatriz Ângelo, Loures, Portugal; Faculdade de Medicina, Universidade de Lisboa, Portugal.
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