Safety of Covid-19 Vaccine in Patients with Inflammatory Bowel Disease: Data of a National Study (Escape-Ibd)

ABSTRACT

Introduction: Vaccination is the most effective method to prevent and control the SARS-CoV-2 infection. Recommendations consider patients with inflammatory bowel disease (IBD), Crohn's disease (CD) and ulcerative colitis (UC), a high-priority population to COVID-19 vaccine administration. There were a lot of concerns about vaccination safety in the setting of biological and immunomodulatory drugs. The purpose of this study was to present data on safety about anti-SARSCoV- 2 vaccination in a cohort of IBD patients. These are data of an ongoing multicenter study assessing effectiveness and safety of COVID-19 vaccines in patients with IBD treated with immunomodulatory or biological drugs (ESCAPE-IBD) sponsored by the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD - ClinicalTrials.gov Identifier NCT04769258). Aims & Methods: Anti-SARS-CoV-2 vaccination was administrated to 809 IBD patients. Afterwards completed vaccination, telephone or in-person interviews were conducted from February to July 2021 by gastroenterologists from referral center to report local and/or systemic adverse events (AEs) related to vaccination. Data on medical history and treatment was collected from electronic health records. Of these 809, 346 patients were surveyed on the pandemic burden and the main reason for hesitancy in Covid-19 vaccination. 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 AEs. Result(s) 809 patients, 456 CD and 353 UC, regularly followed in IBD unit, were enrolled. All patients received a complete SARS-CoV-2 vaccination cycle. Most of them (68%) were in biological or immunomodulatory therapy. About 45% of patients had at least one side effect, following the first dose (10%), the second (15%) or both doses (20%). Local pain at site of injection (24%), fatigue (33%) and fever (30%) were the three most common AEs. Flares of the underlying IBD were not reported. The vast majority of AE were mild and lasted only a few days. No serious AEs were reported and no patient was hospitalized. Logistic regression analysis revealed that female gender (p<0.001), younger age (p=0.001), seroconversion (p=0.002) and comorbidity (p<0.001) were significantly associated with the occurrence of AEs. Futhermore the survey showed that the pandemic did not affect IBD at all in 37.5%, and a lot in 9.2% of participants. The majority (95%) of patients welcomed the possibility of getting vaccinated;only 7% feared the vaccine's influence on the course of the IBD. The main concerns were the possibility of adverse effects (33%) and the failure to achieve immunity (17%), few for the type of vaccine (3%) and for the need to a further booster (6%). Almost all patients (99%) felt safer to have vaccinated at their IBD reference center. Conclusion(s) The short-term vaccine reactions experienced in this cohort of IBD patients were mostly self-limiting, including local pain at the injection site, fatigue and fever. We found a high acceptance rate and a good safety profile of SARS-CoV-2 vaccination in our cohort.