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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)
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Background: Population-based data regarding outcomes of coronavirus disease 2019 (COVID-19) among patients with ulcerative colitis (UC) and Crohn's disease (CD) remain limited. Methods: We conducted a population-based study investigating the outcomes of COVID-19 among patients with UC and CD in Denmark. The Danish COVID-19 IBD Database is an extensive populationbased database which prospectively monitors the disease course of laboratory-confirmed COVID-19 among patients with UC and CD. Severe COVID-19 was defined as COVID-19 necessitating intensive care unit admission, ventilator use, or death, while adverse COVID- 19 was defined as requirement of COVID-19 related hospitalization. Regression analysis was adjusted for age, sex, disease type, disease activity, cardiovascular disease, and corticosteroids. Outcomes of COVID-19 among patients with UC and CD were compared with those among the background population covering all incidents of COVID-19 in Denmark. Results: The study included 319 patients with UC and 197 patients with CD from January 28th, 2020, to April 1st, 2021. Baseline characteristics are presented in Table 1. A significantly higher risk of COVID- 19-related hospitalization was observed among patients with UC (N=46(14.4%), RR=2.49 (95%CI 1.91-3.26)) and CD (N=24(12.2%), RR=2.11 (95%CI 1.45-3.07)) as compared with the background population (N=13,306 (5.8%)). A similar pattern was observed for admission to intensive care (UC: N=8(2.51%), RR=27.88 (95%CI 13.88- 56.00);CD: N=3 (1.52%), RR=16.92 (95%CI 5.46-52.46)) (Figure 1). The association between these outcomes and IBD-related clinical characteristics and treatments is presented in Tables 2-3. As shown, none of the IBD-related medications were associated with severe COVID-19 in univariate and multivariable analysis. However, systemic steroids were found to be associated with an increased risk of adverse COVID-19 among patients with CD (adjusted odds ratio (aOR)=13.62 (95% CI 1.98-17.77)). Conclusion: This Danish population-based study on COVID-19 outcomes among patients with UC and CD demonstrated severe COVID-19 among only a minority of patients, which was not associated with IBD-related medications. Apart from systemic steroids, this study encourages continued use of IBD therapy to prevent IBD relapse and complications.
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Background: The coronavirus disease 2019 (COVID-19) pandemic raised concerns among patients with ulcerative colitis (UC) and Crohn's disease (CD) fearing an increased susceptibility to infection and increased risk of poor outcomes. Furthermore, the impact of COVID-19 on subsequent health-related quality of life (HRQoL) has so far not been described. We aimed to evaluate the HRQoL in relation to the severity of COVID-19 in a cohort of survivors. Methods: We conducted a population-based study investigating the outcomes of COVID-19 among patients with UC and CD in Denmark. The Danish COVID-19 IBD Database is an extensive populationbased database which prospectively monitors the disease course of laboratory-confirmed COVID-19 among patients with UC and CD. Severe COVID-19 was defined as COVID-19 necessitating intensive care unit admission, ventilator use, or death, while adverse COVID- 19 was defined as requirement of COVID-19 related hospitalization. HRQoL was assessed using several validated questionnaires, including the EuroQol five-dimension five-level (EQ-5D-5L) questionnaire, EuroQol Visual Analogue Scale (EQ-VAS), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), IBD Disability Index (IBD-DI), and IBD Fatigue Score. Results: HRQoL after COVID-19 was assessed among 137/319 (42.9%) patients with UC of whom 125 (91.2%) and 12 (8.8%) patients experienced mild and adverse COVID-19, respectively. Furthermore, HRQoL was assessed among 85/197 (43.1%) patients with CD of whom 74 (87.1%) and 11 (12.9%) patients experienced mild and adverse COVID-19, respectively. HRQoL was assessed after a median of 5.1 months (IQR 4.5-7.9) after infection. Baseline characteristics are presented according to the availability of HRQoL data in Table 1. No difference was observed in terms of EQ-5D-5L among patients with UC and CD or patients with mild, adverse, or severe COVID-19 (Table 2). Accordingly, the SIBDQ scores were similar among patients with mild, adverse or severe COVID-19 and UC (mild: median 59 (IQR 50-65), adverse: 62 (54-65), severe: 62 (54-65), p=0.89) or CD (mild: 57 (46- 65), 58 (49-64), 58 (49-64), p=0.91) as well, and no difference was observed in the subscores (Table 2). In line with these results, the IBD Disability Index (UC: median 10 (IQR 6-16), CD: 13 (6-20), p=0.16) were not associated with the severity of COVID-19 (Table 3). Finally, CD patients with adverse COVID-19 experienced more fatigue than patients with mild COVID-19 (26 (IQR 25-35) vs. 41 (IQR 29-46), p=0.03). Conclusion: This Danish population-based study found no durable impact of COVID-19 on health-related quality of life among patients with inflammatory bowel disease providing further assurance for the clinical guidelines for IBD care during the pandemic.
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Background: The vast majority of patients with ulcerative colitis (UC) and Crohn's disease (CD) who acquire coronavirus disease 2019 (COVID-19) survive the infection. Still, the long-term health consequences of COVID-19 are not well described in patients with underlying inflammatory bowel disease (IBD). Methods: We conducted a population-based study investigating the outcomes of COVID-19 among patients with UC and CD in Denmark. The Danish COVID-19 IBD Database is an extensive population-based database which prospectively monitors the disease course of laboratory-confirmed COVID-19 among patients with UC and CD. Severe COVID-19 was defined as COVID-19 necessitating intensive care unit admission, ventilator use, or death, while adverse COVID-19 was defined as requirement of COVID-19 related hospitalization. Sequelae following COVID-19 were defined as symptoms that developed during or after an infection consistent with COVID- 19, were present for more than 12 weeks, and were not attributable to alternative diagnoses. Results: The study included 319 patients with UC and 197 patients with CD from January 28th, 2020, to April 1st, 2021. Of these, a total of 137 (42.9%) and 85 (43.1%), respectively, participated in a subsequent investigation of post-COVID-19 sequelae after a median of 5.1 months (IQR 4.5-7.9) after infection (Table 1). An equal proportion of patients with UC (58 (42.3%)) and CD (39 (45.9%), p=0.60) reported persisting symptoms of COVID-19 for at least 12 weeks, consistent with the development of post-COVID-19 syndrome. The most common persisting patient-reported symptoms included fatigue (UC: 49 (35.8%), CD: 31 (36.5%), p=0.92), anosmia (UC: 37 (27.0%), CD: 25 (29.4%), p=0.70), ageusia (UC: 26 (19.0%), CD: 24 (28.2%), p=0.11), headache (UC: 19 (13.9%), CD: 16 (18.8%), p=0.32), dyspnea (UC: 19 (13.9%), CD: 16 (18.8%), p=0.32), and arthralgia (UC: 17 (12.4%), CD: 14 (16.5%), p=0.40) (Figure 1). Only discontinuation of immunosuppressive therapies for UC during COVID-19 (OR=1.50 (95% CI 1.07-10.22), p=0.01) and the severity of COVID-19 among patients with CD were independently associated with the long-term effects of COVID-19 (OR=2.76 (95% CI 1.05- 3.90), p=0.04) (Tables 2-3). Conclusion: This Danish population-based study found a high occurrence of patient-reported persisting symptoms following the acute phase of COVID-19 infection, which were associated with the discontinuation of immunosuppressive therapies for UC during COVID-19 and the severity of COVID-19 among patients with CD. These findings might have implications for planning the healthcare of patients with inflammatory bowel diseases in the post-COVID-19 era.
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Background: Whether the disease activity of ulcerative colitis (UC) and Crohn's disease (CD) is correlated with the severity of coronavirus disease 2019 (COVID-19) remains poorly investigated with only few selected cohort studies having addressed this in the past. Methods: We conducted a population-based study investigating the outcomes of COVID-19 among patients with UC and CD in Denmark. The Danish COVID-19 IBD Database is an extensive population-based database which prospectively monitors the disease course of laboratory-confirmed COVID-19 among patients with UC and CD. Severe COVID-19 was defined as COVID-19 necessitating intensive care unit admission, ventilator use, or death, while adverse COVID-19 was defined as requirement of COVID-19 related hospitalization. Clinical disease activity was measured by simple clinical colitis index and Harvey-Bradshaw Index in UC and CD, respectively. The biochemical activity was defined as C-reactive protein higher than 5 mg/L or fecal calprotectin higher than 250 μg/g. The endoscopic activity was defined as Mayo Endoscopic Subscore of at least 2 in UC, or Simple Endoscopic Score Crohn's Disease of at least 3 for CD. Sequelae following COVID-19 were defined as symptoms that (i) developed during or after an infection consistent with COVID-19, (ii) and were present for more than 12 weeks, (iii) and were not attributable to alternative diagnoses. Results: During the inclusion period between January 28th, 2020, to April 1st, 2021, the study included 319 patients with UC and 197 patients with CD who developed laboratory confirmed COVID-19. Of these, data on clinical, biochemical, and endoscopic activity were available among 265/319 (83.1%), 319/319 (100.0%), and 66/319 (20.7%) of patients with UC, respectively, and 140/197 (71.1%), 131/197 (66.5%), and 42/197 (21.3%) of patients with CD. Figures 1-2 outlines the outcomes of COVID-19 according to the degree of clinical, biochemical and endoscopic disease activity. In both UC and CD, clinical, biochemical, and endoscopic activity were not associated with adverse or severe COVID-19, nor long-term outcomes, in unadjusted nor adjusted analysis (Table 1). Conclusion: In this population-based study, we found no association between disease activity of UC or CD and severity of COVID-19. These findings have implications for the risk stratification of patients with IBD acquiring COVID-19.
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INTRODUCTION: The COVID19 pandemic has been primarily mitigated with behavioralstrategies such as social distancing, mask wearing, increased hand washing, and stay athome orders. Negative consequences were increased isolation, lack of access to medicalservices, medication shortages, and scarcity of daily necessities;all of which can lead toadverse mental health consequences. The aim of the current international study was todescribe the effect of the pandemic on the well-being of people with gastrointestinal (GI)diseases. METHODS: In this cross-sectional study, participants were recruited through socialmedia ads, posted by patient organizations, opinion leaders, and the authors from May toOctober 2020, and asked to complete online surveys. Psychological distress was measuredwith the Depression, Anxiety and Stress Scale (DASS), GI symptoms with the GastrointestinalSymptoms Rating Scale (GSRS), and quality of life (QoL) with the World Health OrganizationQuality of Life scale (WHOQOL). All questionnaires were in English and answered byEnglish speakers only. Three separate regressions were run with psychosocial distress, QoL,and GI symptoms as dependent variables and self-reported impacts of the pandemic on GIdisease as the independent variables. All models controlled for gender and self-reported prepandemiclevels of the dependent variables. RESULTS: 831 people participated from 22countries (top five were: 37.7% England, 12.2% Australia, 9.5% Poland, 8.3% New Zealand,7.6% USA). Mean age was 49.3 years;82.3% female. The most common GI conditions wereinflammatory bowel disease (38.4%), celiac disease (33.6%), and irritable bowel syndrome(31.4%). Table 1 shows the self-reported impact of the pandemic on aspects of care fortheir GI condition(s). Table 2 shows significant correlations between all these challengesand ratings of psychosocial distress, GI symptoms, and QoL. Regression analyses indicatedthat increased GI symptoms during the pandemic (R2= 0.65) were associated with increaseddifficulties relayted to managing GI disease (ß=0.133, p=0.009), appointments with primarycare doctor (ß=0.152, p=0.013), and diet adherence (ß=0.143, p=0.016). Decreased QoLduring the pandemic (R2= 0.60) was associated with perceived difficulties in accessing toiletpaper (ß=-2.611, p=0.010). None of the variables were associated with psychological distressafter controlling for pre-pandemic levels. CONCLUSION: COVID19 pandemic is affectingGI patients by restricting access to care, medications, toilet paper, and usual diet. Qualityof life and GI symptoms were associated with these challenges, but no effect was found formental health. These findings indicate that the COVID19 pandemic is having adverse impactson GI patients that should be mitigated with future appropriate planning and preventionstrategies.(Table Presented) (Table Presented)
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Background Although several studies have reported the impact of fears relating to COVID-19 on several chronic illness populations, there are few studies focused on gastrointestinal (GI) conditions. The aim was to compare how fear of COVID-19 is manifested in people living with Inflammatory Bowel Disease (IBD) compared to other GI conditions across different demographic backgrounds (employment status, education level and country of residence) using a large international sample. Method Participants with a GI condition (≥18years of age) were recruited from 22 countries through a web-based questionnaire. Demographic, clinical, and psychosocial information was collected in relation to the COVID-19 pandemic. An adaptation of the scale developed for IBD by Trindade & Ferreira (2020, Figure 1) measuring fear of COVID-19 (FoC;original items 1-9) and GI specific fear of COVID-19 (GI-FoC;new items 10-14) was used. Oneway ANOVA or x2 test was chosen as appropriate. Results In 831 participants (312 IBD), there were no significant differences in FoC between IBD and other GI conditions;whilst significant increases in GI-FoC were found in IBD respondents (mean [SD]: 13.5 [5.5] vs. 10.9 [5.0], p<0.01). The greatest fears of IBD respondents were: their condition would get worse;impact on access to medical support;being at increased risk of getting COVID-19;and being at increased risk of death if they got COVID-19. Having an unclassifiable employment status, e.g. redundancy, (mean [SD], unclassifiable: 33.3 [9.3], employed/students: 25.9 [8.3], unemployed: 28.6 [11.5], retired/ home duties: 27.2 [8.6], p<0.01) impacted on IBD respondents having FoC (and near significant GI-FoC [p=0.051]). Those individuals were more afraid of contracting COVID-19 or having contact with other people. Participants living in a rural setting had significantly more FoC and GI-FoC (mean [SD], rural setting: 28.9 [9.9] & 13.3 [5.5], regional setting: 25.5 [7.9] & 12.9 [5.0], metropolitan setting: 27.0 [8.9] & 13.3 [5.5], p=0.04 & 0.03, respectively). These participants were more afraid of having contact with other people, going outside, and believed that they are more likely to get COVID-19 and more likely to die if they got COVID-19 due to their IBD. There were no differences in FoC and GI-FoC by education levels. However, participants with higher education were less afraid of dying from COVID-19 (question 9, p<0.01). Conclusion Respondents with IBD are more afraid of the consequences of COVID-19 due to their disease compared to other GI diseases;especially, persons with undefinable employment status or persons living in a rural setting. Persons with higher education were less afraid of dying from COVID-19. These findings should be taken into consideration to personalize the support health care providers can offer in mitigating fear related to COVID-19 in IBD patients.(Table Presented)
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Introduction: Although several studies have reported the impact of fears relating to COVID-19 on several chronic illness populations, there are few studies focused on gastrointestinal (GI) conditions1-4. The aim was to compare how fear of COVID-19 is manifested in people living with Inflammatory Bowel Disease (IBD) compared to other GI conditions;and, how fear of COVID-19 is manifested across different demographic backgrounds (employment status, education level and country of residence) among IBD respondents using a large international sample. Aims & Methods: Participants with a GI condition (≥18years of age) were recruited from 22 countries through a web-based questionnaire. Demographic, clinical, and psychosocial information was collected in relation to the COVID-19 pandemic. An adaptation of the scale developed for IBD by Trindade & Ferreira (2020)5 measuring fear of COVID-19 (FoC;original items 1-9) and GI specific fear of COVID-19 (GI-FoC;new items 10-14) was used. Results: In 831 participants (312 IBD), there were no significant differences in FoC between IBD and other GI conditions;whilst significant increases in GI-FoC were found in IBD respondents (mean [SD]: 13.5 [5.5] vs. 10.9 [5.0], p<0.01). The greatest fears of IBD respondents were: their condition would get worse;impact on access to medical support;being at increased risk of getting COVID-19;and being at increased risk of death if they got COVID-19. Among IBD respondents, persons on sick leave had significantly more FoC than those employed (median [IQR], 31.0 [28.5-39.5] vs 26.0 [20.0-33.0], p=0.035), and significantly more GI-FoC compared to the employed (18.0 [14.5-22.0] vs 13.0 [9.0-17.0], p=0.033) or respondents outside of the labour market (12.0 [7.0-16.0], p=0.022). Persons living in a rural setting had significantly more FoC compared to persons living in regional setting (29.5 [22.0-37.8] vs 25.0 [20.0-31.3], p=0.007) and GI-FoC (15.0 [11.0-19.8] vs 12.0 [9.0-16.0], p=0.02). These persons were fearful of contracting COVID-19, having contact with someone with respiratory symptoms, having contact with healthcare professionals, going outside, meeting people, having contact with someone who was in contact with an infected person, having contact with someone infected with COVID-19, and that their IBD means being at increased risk of death if they got COVID-19. There were no differences in general FoC and GI-FoC according to educational background. However, respondents with higher education were less afraid of dying from COVID-19. Conclusion: Respondents with IBD are more afraid of the consequences of COVID-19 due to their disease compared to other GI diseases;especially, persons on sick leave or persons living in a rural setting. Persons with higher education were less afraid of dying from COVID-19. These findings should be taken into consideration to personalise the support health care providers can offer in mitigating fear related to COVID-19 in IBD patients.