IMPLEMENTATION AND SHORT-TERM ADVERSE EVENTS OF ANTI-SARSCOV-2 VACCINES IN INFLAMMATORY BOWEL DISEASE PATIENTS: AN INTERNATIONAL WEB-BASED SURVEY

Introduction: 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. Methods: 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. Results: Among the 3272 IBD patients completing the survey (0.1% of the IBD European population), 79.6% had received at least one dose of 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. 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. (Table Presented)

HOSPITALIZATION FOR DRUG INFUSION DOES NOT INCREASE COVID INFECTION RATE, IBD RELAPSES DUE TO INFECTIONS AND LEVELS OF ANXIETY IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE: A COMPARATIVE STUDY

Background and aim: During coronavirus disease 2019 (COVID-19) pandemic, immumodulatory therapies as well as the access to high-risk places (i.e. hospitals, infusion centers) were associated to an increased risk of infection. Nevertheless, patients with inflammatory bowel diseases (IBD) treated with intravenous (i.v.) biologics had to move to hospital for drug infusion, in contrast to patients treated with subcutaneous (s.c.) therapies who could remain at home, monitored through telemedicine. We investigated whether patients hospitalized or treated at home showed similar COVID-19 risk, as well as the levels of anxiety in both groups Materials and methods: We conducted a survey including consecutive IBD patients in clinical and biochemical remission treated with biologics referring to the lockdown period. Patients underwent the normally scheduled clinical visits, performed at home by means of telemedicine for patients treated with s.c. drugs and only in specific cases for patients treated with i.v. therapies. We administered to all patients the Hospital Anxiety and Depression Scale (HADS) questionnaire and other 12 questions, specifically related to COVID and its implications. Group differences in continuous and nominal variables were tested by Kruskal–Wallis test and Fisher exact test, respectively Results: A total of 189 IBD patients were recruited, 112 (59.3%) treated with i.v. drugs and 77 (40.7%) with s.c. ones. No augmented risk of COVID infection were recorded in both groups (hospitalized vs. non-hospitalized, p=ns). The two groups of patients had similar scores in the 14 single items of the HADS questionnaire (p>0.10 for all). The total HADS score obtained by the sum of all items was also almost identical between groups (37.1±2.8 vs 37.2±2.8;p=0.98). In patients treated with i.v. drugs receiving a televisit (n=17), the rates of satisfaction about telemedicine (58.8%) and the lack of in-person care (33.3%) were significantly lower compared with those treated with s.c. drugs (94.8% and 92.2%, respectively;both p<0.0005). Conclusions: Our results suggest that there is no need to convert patients from i.v. to s.c. therapy during COVID-19 outbreaks, since the risk of infection and its transmission is not increased. Moreover, anxiety levels are similar in both groups, emphasizing that hospitalization seems not affecting the psychological status of the patients and therefore not increasing the relapse rate.

Large differences in IBD care and education across Europe, first results of the pan-european viper survey

Introduction: More than 2.5 million people in Europe are diagnosed with inflammatory bowel diseases (IBD). IBD affects the quality of life, but also has important consequences for health systems. It remains unknown if variations in IBD care and education differs across Europe and to help address this question, we conducted this European Variation In IBD PracticE suRvey (VIPER) to study potential differences. Aims & Methods: This trainee-initiated survey, run through SurveyMonkey ®, consisted of 47 questions inquiring basic demographics, IBD training and clinical care. The survey was distributed through social media and national GI societies from December 2020 - January 2021. Results were compared according to GDP per capita, for which countries were divided into 2 groups (low/high income, according to the World Bank). Differences between groups were calculated using the chi2 statistic. Results: The online survey was completed by 1268 participants from 39 European countries. Most of the participants are specialists (65.3 %), followed by fellows in training (>/< 3 years, 19.1%, 15.6 %). Majority of the responders are working in academic institutions (50.4 %), others in public/ district hospitals (33.3 %) or private practices (16.3 %). Despite significant differences in access to IBD-specific training between high (56.4%) and low (38.5%) GDP countries (p<0.001), majority of clinicians feels comfortable in treating IBD (77.2% vs 72.0%, p=0.04). GDP was not a factor that dictated confidence in treating patients. IBD patients seen per week, IBD boards and especially IBD specific training were factors increasing confidence in managing IBD patients. Interestingly, a difference in availability of dedicated IBD units could be observed (58.5% vs 39.7%, p<0.001), as well as an inequality in multidisciplinary meetings (72.6% vs 40.2%, p<0.001), which often take place on a weekly basis (53.0%). In high GDP countries, IBD nurses are more common (86.2%) than in low GDP countries (36.0%, p<0.001), which is mirrored by differences in nurse-led IBD clinics (40.6% vs 13.8%, p<0.001). IBD dieticians (32.4% vs 16.6%) and psychologists (16.7% vs 7.5%) are mainly present in high GDP countries (p<0.001). In the current COVID era, telemedicine is available in 58.4% vs 21.4% of the high/low GDP countries respectively (p<0.001), as well as urgent flare clinics (58.6% vs 38.7%, p<0.001) and endoscopy within 24 hours if needed (83.0% vs 86.7% p=0.1). Treat-to-target approaches are implemented everywhere (85.0%), though access to biologicals and small molecules differs significantly. Almost all (94.7%) use faecal calprotectin for routine monitoring, whereas half also use intestinal ultrasound (47.9%). Conclusion: A lot of variability in IBD practice exists across Europe, with marked differences between high vs low GDP countries. Further work is required to help address some of these inequalities, aiming to improve and standardise IBD care across Europe.