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Background: COVID-19 vaccination has been suggested as very effective in patients with Inflammatory Bowel Disease (IBD), but most studies assess antibody levels within a few weeks after vaccination and do not use the most recent recommendations as seroconversion cut-off. The objective of VACOVEII study is to evaluate the antibody response to vaccination at 6 months using these recommendations, the improvement after a booster dose and the effect of the immunosuppressive therapy (IST). We present the intermediate results of the study. Method(s): Spanish multicentre, prospective and case-control study. 18 years or older IBD patients fully vaccinated against COVID-19 were included. Those with previous COVID infection were not included, but not excluded for the next analyses if the infection was subsequent. Main outcomes were anti-SARS-CoV-2 spike protein antibody (anti S) concentrations and rate of seroconversion (defined above the protection threshold of 260 BAU/mL), measured 6 months after vaccination at a single centralized laboratory. The effect of IST on the main outcomes was analysed, adjusted by age, vaccine type and COVID infection. Groups of treatment considered for the analysis were: Patients without IST (without treatment or under salicylates alone), anti-TNF in combination with immunomodulators (IMM), anti-TNF in monotherapy, IMM in monotherapy, ustekinumab and anti-integrin. Result(s): We included 313 patients with IBD (46.5% ulcerative colitis and 52.3% Crohn's disease, median age 49 years) vaccinated either with non-mRNA vaccines (14%) or mRNA vaccines (86%). Baseline therapy was: 124 patients without IST, 21 with anti-TNF plus IMM, 67 with anti-TNF in monotherapy, 54 with IMM in monotherapy, 28 with ustekinumab and 19 with anti-integrin. Mean anti S concentrations were significant lower in patients with anti-TNF compared with patients without IST (Figure 1). In multivariable analysis, lower antibody concentrations were independently associated with anti-TNF treatment, non-mRNA vaccines and older age. Within the patients with no COVID infection during the follow-up, we found very low rates of seroconversion in patients with anti-TNF (14.1%), ustekinumab (30.8%) and IMM in monotherapy (34.9%), compared with patients without IST (51.5%) (Table 1). In multivariable analysis, anti-TNF treatment, non-mRNA vaccines and older age were independently associated with lower rates of seroconversion, as well as ustekinumab and IMM in monotherapy (Table 2). Conclusion(s): COVID-19 vaccine-induced antibody seroconversion in patients with IBD, measured at 6 months and according to >260 BAU as protection threshold, is clearly lower than previously reported, with a profound impact by some IST therapies, mainly anti-TNF, besides age and type of vaccine.
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Background: COVID-19 pandemic increased medical services demand aside from interrupting daily clinical practice for other diseases such as inflammatory bowel disease (IBD). Here we present the results of a survey to gain the perception of IBD specialists in their patient-management using telemedicine in their daily practice. Methods: This was an observational survey study among physicians focused on IBD (gastroenterologist, surgeons, and pediatricians) members of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU), the Spanish Association of Gastroenterology (AEG), and the Spanish Association of Coloproctology (AECP), regarding changes of management of IBD patients. Results: We received a total of 269 responses to the survey (from May to June 2020). Before the pandemic, nearly all the respondents reported performing very frequently their visits face-to-face (n = 251, 93.3%) while, during the pandemic, the telephone visits were the most frequent visits performed (n = 138, 51.3%). Regarding communication difficulties, 157 (58.4%) respondents reported the impossibility of performing a proper examination as the most relevant issue. Also, 114 (42.4%) respondents considered remote visits more time-consuming than face-to-face visits. Most gastroenterologists (n = 188, 83.2%) considered patients with active perianal disease in special need of face-to-face consultation and more than half of the surgeons (n = 35, 50.7%) reported having performed an immediate postoperative follow-up remotely. Conclusions: Most IBD units have implemented remote visits during the pandemic, but most professionals found them more time-consuming and unsuitable for some disease profiles. Therefore, there is a need for the development of better telemedicine systems that can meet professionals’ and patients’ requirements.
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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: The exhaustive registry of COVID-19 cases in patients with IBD is a unique opportunity to learn how to deal with this infection, especially in reference to the management of immunosuppressive treatment, isolation measures or if the disease is more severe in IBD patients due to immunosuppression. Aims & Methods: Aims: The aims of this study were to know the incidence and characteristics of COVID-19 in the ENEIDA cohort during the first wave of the pandemic;the outcomes among those under immunosuppressants/ biologics for IBD;the risk factors for contracting the infection and poor outcomes;and the impact of the infection after three-month followup. Methods: Prospective observational cohort study of all IBD patients with COVID-19 included in the ENEIDA registry (with 60.512 patients in that period) between March and July 2020, with at least 3 months of follow-up. Any patient with a confirmed (by PCR or SARS-CoV-2 serology) or probable (suggestive clinical picture) infection was considered as a case. Results: A total of 482 patients with COVID-19 from 63 centres were included: 247 Crohn's disease, 221 ulcerative colitis and 14 unclassified colitis;median age 52 years (IQR: 42-61), 48% women and 44% 1 comorbidity. Diagnosis was made by PCR: 62% and serology: 35%. The most frequent symptoms: fever (69%), followed by cough (63%) and asthenia (38%). During lockdown 78% followed strict isolation. 35% required hospital admission (ICU: 2.7%) and 12% fulfilled criteria for SIRS upon admission. 18 patients died from COVID-19 (mortality:3.7%). 12% stop IBD medication during COVID-19. At 3 months, taken into account all included cases, 76% were in remission of IBD. Age 50 years (OR 2.09;95% CI:1.27-3.4;p=0.004), 1 comorbidities (OR 2.28;95% CI:1.4-3.6;p=0.001), and systemic steroids <3 months before infection (OR 1.3;95%CI:1-1.6;p= 0.003), were risk factors for hospitalisation due to COVID-19. A Charlson score 2 (OR 5.4;95%CI:1.5-20.1;p=0.01) was associated with ICU admission. Age 60 years (OR 7.1;95%CI:1.8-27.4;p=0.004) and having 2 comorbidities (OR 3.9;95% CI:1.3-11.6;p=0.01) were risk factors for COVID- 19 related death. Conclusion: IBD does not seem to worsen the prognosis of COVID-19, even when immunosuppressants and biological drugs are used. Age and comorbidity are the most important prognostic factors for more severe COVID-19 in IBD patients.
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Introduction: The information regarding IBD patients with COVID-19 suggests that the factors related to bad outcome are older age and comorbidity whereas immunosuppressants do not have a significant impact worsening the disease evolution. Aims & Methods: Aims: To assess if there are differences in epidemiological, demographical, and clinical characteristics between infected and non-infected IBD patients. Methods: Case-control study in IBD patients with COVID-19 (cases) compared to IBD without COVID-19 (controls) in the period March-July/2020 within the ENEIDA registry (promoted by GETECCU and with more than 60.000 IBD patients included). Cases were matched 1:2 by age (±5y), type of disease (CD/UC), gender, and centre. All controls were selected from only one investigator blind to other clinical characteristics of the patients to avoid selection bias. Results: 482 cases and 964 controls from 63 Spanish centres were included. No differences were found within the basal characteristics including CD location, CD behaviour, extraintestinal manifestations, family history of IBD or smoking habits. Cases had ≥ 1 comorbidities (cases:43%vs. controls: 35%, p=0.01) and occupational risk (cases:27% vs. controls:10.6%, p<0.0001) in a higher proportion. Strict lock-down was the only measure demonstrating protection against COVID-19 (cases:49% vs. controls:70%, p<0.0001). There were no differences in the use of systemic steroids (p=0.19), immunosuppressants (p=0.39) or biologics (p=0.28) between cases and controls. Cases were more often treated with aminosalycilates (42% vs.34%, p=0.003). Having ≥ 1 comorbidities (OR:1.6, 95%CI: 1.2-2.1), occupational risk (OR:1.95, 95%CI:1.39-2.7) and the use of aminosalycilates (OR:1.4, 95%CI: 1-1.8) were risk factors for COVID-19. On the other hand, strict lockdown was a protective factor (OR:0.38, CI:0.29-0.49). Conclusion: Comorbidities and epidemiological risk factors are the most relevant aspects for the risk of COVID-19 in IBD patients. This risk of COVID- 19 seems to be increased by aminosalycilates but not by immunosuppressants or biologics. The attitude regarding treating IBD patients with aminosalicylates during COVID-19 pandemic deserves a deeper analysis. (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.
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Introduction: Few studies have examined the effects of COVID-19 on the mental health of patients with inflammatory bowel disease (IBD), who are already at higher risk of depression, anxiety and stress than the general population. Aims & Methods: This cross-sectional study was conducted to assess the psychosocial impact of COVID-19 on patients with IBD in Spain during lockdown and the first wave of the pandemic. A self-report questionnaire that integrated the Spanish version of the Depression, Anxiety and Stress Scale-21 items (DASS-21) and the Perceived Stress Questionnaire (PSS) was designed to gather sociodemographic data and information related to the effects of COVID-19 on the lives of IBD patients. Twelve IBD units invited their patients to answer the anonymous online survey via email or by using a QR code displayed at the unit. A link to the survey was also published on the GETECCU (Spanish IBD group) website and social media account. The survey was conducted between the 1st July and the 25th August 2020. Results: Of the 693 survey participants with IBD, 67% were female, mean age 43 (12y SD). 61% had ulcerative colitis, 36% Crohn's disease 3% indeterminate colitis. Only 15 participants were diagnosed with COVID-19: 3 of them required hospital admission and none required ICU admission. Physical activity levels and sleep habits were adversely affected for 79% and 67% of respondents, respectively. In addition, 39% reported a decrease in income due to the pandemic. 95% report having complied with IBD treatment during the COVID-19 pandemic, despite over 50% of them feeling that they were more at risk of infection due to their medication. DASS-21 scores indicate that during the lockdown the estimated prevalence of depression was 10.5% [95% CI 8.2-13%], anxiety 20% [95% CI -17- 23%] and stress 18% [95% CI 8.2-13%]. Conclusion: In the short-term, lockdown during the COVID-19 pandemic has had a considerable impact on the mental health of IBD patients in Spain. Further follow-up studies should be carried out to determine the real long-term impact.
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Introduction: Several vaccines against SARS-CoV-2 are currently in use and are recommended in inflammatory bowel disease (IBD) patients. Data are scarce about the gastroenterologist and IBD patients acceptance of SARS-CoV-2 vaccines. Aims & Methods: The aim of the study was to evaluate the intention to get vaccination with SARS-CoV-2 vaccine among IBD patients from gastroenterologists and patient's perspective. An online anonymous survey was sent to 8000 patients from a national patient association (ACCU-Spain) and 1000 members of the Spanish IBD Working Group (GETECCU). Three invitations were sent between October-December 2020. The specific questions about SARS-CoV-2 vaccination were added in two different surveys for physicians and patients of de VACUNEII project jointly designed by ACCU and GETECCU. Descriptive analyses were performed, comparing physicians and patients responses by standard statistical analyses. Results: 144 gastroenterologists [63% female, mean age 43 years (SD 9.5)], and 1302 patients [72% female, mean age of 43 years (SD 12)] responded to the survey. 95% of the physicians recommended SARS-CoV-2 vaccine for IBD patients and 87% consider that their vaccination strategies has not changed after the pandemic compared to 12% who considered that they currently refer more patients to vaccination. Regarding to IBD patients, only 43% of patients were willing to receive the vaccine and 43% were not sure. Male sex (p<0.001) and mesalazine treatment (p=0.021) were positively associated with SARS-CoV-2 vaccine acceptance. Female sex was associated with the belief that the influenza or pneumococcal vaccine prevented SARS-CoV-2 infection (p=0.03). After multivariate analysis, only male sex was significantly associated with vaccination intent (OR=1.6;95% confidence interval=1.2-2.0;p = 0.001). Conclusion: Gastroenterologists and patient's perspectives about SARSCoV2 are different. Future efforts to increase COVID-19 vaccine acceptance and decrease unfounded beliefs among IBD patients are needed.
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Background: The novel coronavirus emerged in 2019 in Wuhan has caused a global pandemic of coronavirus disease (COVID-19). Immune-mediated diseases (IMID), as inflammatory arthritis or inflammatory bowel disease (IBD), have some special implications due to their pathogenesis and treatments. Some treatments employed in IMID are now being used in the treatment of severe COVID-19. There still exists controversy about IMID behavior and its complications. 1, 2 Objectives: To assess COVID-19 severity in IMID patients and its prognosis predictors. Methods: An observational retrospective multicenter study was performed in two Spanish Hospitals (Clinical University Hospital in Santiago De Compostela and Gregorio Marañón Hospital). Patients were selected if they were diagnosed of an IMID (rheumatoid arthritis, psoriatic arthritis, espondyloarthritis, ulcerative colitis and Crohn's disease) and had COVID-19 infection between February and April 2020. Demographic, clinical, analytical and treatment data were collected. Logistic regression was used to evaluate potential predictors. Stata 15.1 was used to perform statistical analysis. Results: 91 patients were recruited. 55 suffered from a rheumatic disease and 36 suffer IBD. Baseline characteristics are shown in Table 1. Univariable analysis reached age, comorbidity, female gender, flu vaccine, arthropathy, basal classical synthetic anti-rheumatic drugs (csDMARD), pneumonia and basal C-reactive protein (CRP) as potential predictors of non-severe (absence of death, respiratory insufficiency, intensive care unit admission or sepsis) COVID-19 disease (p < 0.2). After multivariable analysis, only female gender (OR 4.60 [CI95% 1.00, 21.2] p=0.050), lower age (OR 0.94 [CI95% 0.88, 1.00] p=0.042) and lower basal levels of CRP (OR 0.87 [CI95% 0.77, 0.97] p=0.010) were predictors for non-severe disease (p < 0.005). Mean time of healing (symptoms solved in outpatient and hospital discharge in admitted) from COVID-19 was 13.8 days (SD 16.3). Univariable analysis showed arthropathy, COVID-19 symptomatic and basal glucocorticoids (GC) dose as potential predictors of higher time-to-healing from COVID-19 disease (p < 0.2). After multivariable analysis, only lower GC basal dose predicts higher time-tohealing (OR -1.83 [CI95% -2.81, -0.84] p=0.001). 11 patients deceased because of COVID-19. Univariable analysis reached age, basal csDMARD, pneumonia and basal CRP as potential predictors of COVID-19 mortality (p < 0.2). After multivariable analysis, only higher age was a predictor for mortality (OR 1.14 [CI95% 1.04,1.25] p=0.006). Conclusion: IMID patients showed similar predictors of mortality than general population involving COVID-19. Immune-modulating agents did not seem to overshadow the prognosis of COVID-19 infection. Female gender, lower age and lower basal CRP could select a cohort of “good” prognosis patients with mild COVID-19 disease as well higher age points out the worst prognosis. Even that, each case should be individiualized.