Pierre Ellul1, Joana Revés2, Bárbara Abreu2, María Chaparro3, Javier P Gisbert3, Mariangela Allocca4,5, Gionata Fiorino4,5, Brigida Barberio4,5, Fabiana Zingone4,5, Anthea Pisani1, David Cassar1, George Michalopoulos6, Gerassimos Mantzaris7, Ioannis Koutroubakis8, Konstantinos Karmiris9, Konstantinos Katsanos10, Dana Ďuricova11,12, Johan Burisch13,14, Gorm Roager Madsen13,14, Christian Maaser15, Arebi Naila16, Eleni Orfanoudaki8, Vladimir Milivojevic17, Anthony Buisson18,19, Luisa Avedano20, Salvo Leone20, Joana Torres2,21. 1. Division of Gastroenterology, Mater Dei Hospital, Msida,Malta. 2. Gastroenterology Division, Surgical Department, Hospital Beatriz Ângelo, Loures,Portugal. 3. Gastroenterology Unit, Hospital Universitario de La Princesa, IIS-IP, UAM, and Centro de CIBEREHD, Madrid,Spain. 4. IBD Center, Humanitas Clinical and Research Center, Milan,Italy. 5. Department of Surgery, DiSCOG, University of Padova, Padova,Italy. 6. Gastroenterology Department Tzaneion General Hospital of Piraeus, Piraeus, Greece. 7. Evangelismos, Ophthalmiatreion Athinon and Polyclinic Hospitals, Crete,Greece. 8. Department of Gastroenterology, University Hospital of Heraklion, Heraklion,Greece. 9. Department of Gastroenterology, Venizeleio General Hospital, Heraklion,Greece. 10. Department of Gastroenterology and Hepatology, Division of Internal Medicine, University and Medical School of Ioannina, Ioannina,Greece. 11. IBD Clinical and Research Centre, ISCARE, Prague,Czech Republic. 12. Institute of Pharmacology, 1st Faculty of Medicine, Charles University, Prague,Czech Republic. 13. Gastrounit, Hvidovre Hospital, University of Copenhagen Hvidovre, Denmark. 14. Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, University of Copenhagen Hvidovre, Denmark. 15. Outpatients Department of Gastroenterology, Hospital Lüneburg, Lüneburg,Germany. 16. St Mark's Hospital, London North West University Healthcare NHS Trust, Harrow,UK. 17. Clinic for Gastroenterology and Hepatology, Clinical Center of Serbia, School of Medicine, Belgrade,Serbia. 18. Université Clermont Auvergne, Inserm, CHU Clermont-Ferrand, 3iHP, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France. 19. Université Clermont Auvergne, 3iHP, Inserm U1071, M2iSH, USC-INRA 2018, F-Clermont-Ferrand,France. 20. European Federation of Crohn's and Ulcerative Colitis Associations, Brussels, Belgium. 21. Faculty of Medicine, Lisbon University, Portugal.
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.
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.