tetano
Editor, Senior Moderator
Eur J Gastroenterol Hepatol
. 2023 Apr 4.
doi: 10.1097/MEG.0000000000002550. Online ahead of print. Safety, hesitancy of coronavirus disease 2019 vaccination and pandemic burden in patients with inflammatory bowel disease: data of a national study (ESCAPE-IBD)
Mariabeatrice Principi[SUP] 1 [/SUP], Fabio Salvatore Macaluso[SUP] 2 [/SUP], Alessia Todeschini[SUP] 1 [/SUP], Federica Facciotti[SUP] 3 [/SUP], Antonella Contaldo[SUP] 4 [/SUP], Fabiana Castiglione[SUP] 5 [/SUP], Olga Maria Nardone[SUP] 5 [/SUP], Rocco Spagnuolo[SUP] 6 [/SUP], Patrizia Doldo[SUP] 6 [/SUP], Gaia Riguccio[SUP] 7 [/SUP], Francesco Simone Conforti[SUP] 8 [/SUP], Chiara Viganò[SUP] 9 [/SUP], Marta Ascolani[SUP] 10 [/SUP], Gionata Fiorino[SUP] 11 [/SUP], Carmen Correale[SUP] 12 [/SUP], Giorgia Bodini[SUP] 13 [/SUP], Monica Milla[SUP] 14 [/SUP], Giulia Scardino[SUP] 15 [/SUP], Marta Vernero[SUP] 16 [/SUP], Federico Desideri[SUP] 17 [/SUP], Flavio Caprioli[SUP] 9 18 [/SUP], Mariella Mannino[SUP] 2 [/SUP], Giuseppe Rizzo[SUP] 2 [/SUP], Ambrogio Orlando[SUP] 2 [/SUP]; Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
Affiliations
Background and aims: The purpose of this study was to present data on the safety of anti- severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in a cohort of inflammatory bowel disease (IBD) patients of an ongoing multicenter study (ESCAPE-IBD) sponsored by the Italian Group for the study of Inflammatory Bowel Disease (ClinicalTrials.gov Identifier: NCT04769258).
Methods: Anti-SARS-CoV-2 vaccination was administrated to 809 IBD patients. Interviews were conducted to report adverse events related to vaccination. Of these 809, 346 patients were surveyed on the pandemic burden and the main reason for hesitancy in coronavirus disease 2019 vaccination. The chi-square test was used to compare categorical variables. Logistic regression was used to assess the relationship between disease-related characteristics and the onset of adverse events.
Results: About 45% of patients had at least one side effect, following the first dose (10%), the second (15%), and both doses (19%). All the adverse events were mild and lasted only a few days. Logistic regression analysis revealed that female sex (P < 0.001), younger age (P = 0.001), seroconversion (P = 0.002), and comorbidity (P < 0.001) were significantly associated with adverse events. The survey showed that the main concerns were the possibility of adverse event (33%). Almost all patients (99%) felt safer having been vaccinated at their IBD reference center.
Conclusion: The vaccine reactions experienced in IBD patients were mostly self-limited. We found high acceptance and good safety of SARS-CoV-2 vaccination in our cohort.
. 2023 Apr 4.
doi: 10.1097/MEG.0000000000002550. Online ahead of print. Safety, hesitancy of coronavirus disease 2019 vaccination and pandemic burden in patients with inflammatory bowel disease: data of a national study (ESCAPE-IBD)
Mariabeatrice Principi[SUP] 1 [/SUP], Fabio Salvatore Macaluso[SUP] 2 [/SUP], Alessia Todeschini[SUP] 1 [/SUP], Federica Facciotti[SUP] 3 [/SUP], Antonella Contaldo[SUP] 4 [/SUP], Fabiana Castiglione[SUP] 5 [/SUP], Olga Maria Nardone[SUP] 5 [/SUP], Rocco Spagnuolo[SUP] 6 [/SUP], Patrizia Doldo[SUP] 6 [/SUP], Gaia Riguccio[SUP] 7 [/SUP], Francesco Simone Conforti[SUP] 8 [/SUP], Chiara Viganò[SUP] 9 [/SUP], Marta Ascolani[SUP] 10 [/SUP], Gionata Fiorino[SUP] 11 [/SUP], Carmen Correale[SUP] 12 [/SUP], Giorgia Bodini[SUP] 13 [/SUP], Monica Milla[SUP] 14 [/SUP], Giulia Scardino[SUP] 15 [/SUP], Marta Vernero[SUP] 16 [/SUP], Federico Desideri[SUP] 17 [/SUP], Flavio Caprioli[SUP] 9 18 [/SUP], Mariella Mannino[SUP] 2 [/SUP], Giuseppe Rizzo[SUP] 2 [/SUP], Ambrogio Orlando[SUP] 2 [/SUP]; Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
Affiliations
- PMID: 37115976
- DOI: 10.1097/MEG.0000000000002550
Background and aims: The purpose of this study was to present data on the safety of anti- severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in a cohort of inflammatory bowel disease (IBD) patients of an ongoing multicenter study (ESCAPE-IBD) sponsored by the Italian Group for the study of Inflammatory Bowel Disease (ClinicalTrials.gov Identifier: NCT04769258).
Methods: Anti-SARS-CoV-2 vaccination was administrated to 809 IBD patients. Interviews were conducted to report adverse events related to vaccination. Of these 809, 346 patients were surveyed on the pandemic burden and the main reason for hesitancy in coronavirus disease 2019 vaccination. The chi-square test was used to compare categorical variables. Logistic regression was used to assess the relationship between disease-related characteristics and the onset of adverse events.
Results: About 45% of patients had at least one side effect, following the first dose (10%), the second (15%), and both doses (19%). All the adverse events were mild and lasted only a few days. Logistic regression analysis revealed that female sex (P < 0.001), younger age (P = 0.001), seroconversion (P = 0.002), and comorbidity (P < 0.001) were significantly associated with adverse events. The survey showed that the main concerns were the possibility of adverse event (33%). Almost all patients (99%) felt safer having been vaccinated at their IBD reference center.
Conclusion: The vaccine reactions experienced in IBD patients were mostly self-limited. We found high acceptance and good safety of SARS-CoV-2 vaccination in our cohort.