ABSTRACT
Background The rapid development and distribution of SARS-CoV-2 vaccines has raised concerns surrounding vaccine safety in immunocompromised populations, such as those with inflammatory bowel disease (IBD). Purpose We described adverse events (AEs) following SARS-CoV-2 vaccination in those with IBD and determined relationships between AEs to post-vaccination antibody titres. Method Individuals with IBD from a prospective cohort in Calgary, Canada (n=670) who received a 1st, 2nd, 3rd, and/or 4th dose of a SARS-CoV-2 vaccine (Pfizer-BioNTech, Moderna, and/or AstraZeneca) were interviewed via telephone for AEs using the Adverse Events Following Immunization form. Subsequently, we assessed injection site reaction as a specific AE outcome. Multivariable logistic regression models were used to assess the association between anti-SARS-CoV-2 spike protein antibody (anti-S) levels within 1–12 weeks of vaccination and injection site reaction following 1st, 2nd, and 3rd dose vaccination. Models were adjusted for age, sex, IBD type, IBD medications, vaccine type, and prior COVID-19 infection. Additionally, we evaluated the risk of flare of IBD within 30 days of vaccination via chart review. Result(s) Table 1 describes AEs in individuals with IBD following 1st dose (n=331), 2nd dose (n=331), 3rd dose (n=195), and 4th dose (n=100) of a SARS-CoV-2 vaccine. AEs were reported in 83.3% of participants after 1st dose, 79.1% after 2nd dose, 77.4% after 3rd dose, and 67.0% after 4th dose. Injection site reaction (pain, redness, etc.) was the most common AE (50.8% of AEs), with fatigue and malaise (18.1%), headache and migraine (8.6%), musculoskeletal discomfort (8.2%), and fever and chills (6.5%) also commonly reported. Multivariable logistic regression determined no associations between anti-S concentration and injection site reaction for all doses. Age above 65 years was associated with decreased injection site reaction following 1st and 3rd doses, while female sex and mRNA vaccine type were associated with increased injection site reaction following 1st and 2nd doses. Prior COVID-19 infection, IBD type, and medication class were not associated with injection site reaction with any dose. Only one participant was diagnosed with a severe AE requiring hospitalization: Immune thrombocytopenic purpura (ITP) following 2nd dose of a Pfizer vaccination. No cases of IBD flare occurred within 30 days of vaccination. Image Conclusion(s) AEs following SARS-CoV-2 vaccination are generally mild and become less common with each consecutive dose. Antibody levels following each dose of the vaccine were not associated with injection site reactions. Females, those under 65 years of age, and those administered mRNA vaccines were more likely to experience an injection site reaction. Prior COVID-19 infection, IBD type, and IBD medication class did not predict injection site reactions. Vaccination was not associated with IBD flare within 30 days of vaccination. Please acknowledge all funding agencies by checking the applicable boxes below Other Please indicate your source of funding;Helmsley Disclosure of Interest A. Markovinovic: None Declared, M. Herauf: None Declared, J. Quan: None Declared, L. Hracs: None Declared, J. Windsor: None Declared, N. Sharifi: None Declared, S. Coward: None Declared, L. Caplan: None Declared, J. Gorospe: None Declared, C. Ma Grant / Research support from: Ferring, Pfizer, , Consultant of: AbbVie, Alimentiv, Amgen, Ferring, Pfizer, Takeda, , Speakers bureau of: AbbVie, Alimentiv, Amgen, Ferring, Pfizer, Takeda, R. Panaccione Grant / Research support from: AbbVie, Ferring, Janssen, Pfizer, Takeda, Consultant of: Abbott, AbbVie, Alimentiv, Amgen, Arena, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Mylan, Oppilan Pharma, Pandion Therapeutics, Pandion Pharma, Pfizer, Progenity, Pro agonist, Roche, Sandoz, Satisfai Health, Schering-Plough, Shire, Sublimity Therapeutics, Takeda, Theravance, UCB, Speakers bureau of: AbbVie, Arena, Celgene, Eli Lilly, Ferring, Gilead Sciences, Janssen, Merck, Pfizer, Roche, Sandoz, Shire, Takeda, R. Ingram: None Declared, J. Kanji: None Declared, G. Tipples: None Declared, J. Holodinsky: None Declared, C. Berstein Grant / Research support from: AbbVie, Amgen, Janssen, Pfizer, Takeda, Speakers bureau of: AbbVie, Janssen, Pfizer, Takeda, D. Mahoney: None Declared, S. Bernatsky: None Declared, E. Benchimol: None Declared, G. Kaplan Grant / Research support from: Ferring, Speakers bureau of: AbbVie, Janssen, Pfizer
ABSTRACT
Background Venous thromboembolism (VTE), is associated with significant morbidity and mortality. Inflammation increases the risk of VTE, and it is a well-recognised complication of both inflammatory bowel disease (IBD) and COVID-19. Purpose To compare the risk of VTE among individuals with and without IBD following a positive COVID-19 test. Method Using health administrative data from Ontario, Canada we conducted a retrospective matched cohort study.All Ontario residents with a positive SARS-CoV-2 PCR test between January 1,2020 and December 30,2021 who had been diagnosed with IBD prior to their COVID-19 infection (identified using a validated algorithm) were matched to 5 individuals without IBD based on year of birth, sex, mean neighbourhood income quintile, date of positive COVID-19 test, and rural/urban residence. Individuals with a cancer diagnosis in the 5 years prior to their first COVID-19 positive test were excluded. Individuals were followed from positive COVID-19 PCR test until VTE event, death, migration out of Ontario or March 31, 2022.VTEs were identified from emergency department or hospitalization data using ICD-10 codes. Incidence rate of VTEs among individuals with IBD were assessed at 1, 6 and 12 months. Proportional cause-specific hazards models compared the risk of VTEs in people with and without IBD, treating death as a competing risk and controlling for vaccination status (2nd dose ≥14 days prior to positive COVID-19 test) and a history of VTE (VTE in the 5 years prior to infection). Result(s) There were 4293 people with IBD (44% Crohn's disease, mean age ±SD 46.1±17.2 y) matched to 20,207 with out IBD (mean age 45.3±16.8 y) with a positive SARS-CoV-2 PCR test. Within 1 month of a positive COVID-19 test, the crude incidence rate of VTE in individuals with IBD was 4.77(95%CI, 4.75-4.80) per 100,000 person-days compared to 8.25(95%CI, 8.20-8.30) per 100,000 among people without IBD.Within 6 months, these rates were 1.86(95%CI, 1.86-1.87) and 2.12(95%CI, 2.11-2.12) per 100,000 person-days among people with and without IBD, respectivley. Within 12 months, these rates were 1.59(95% CI, 1.58-1.59) and 1.42(95% CI, 1.42-1.42) per 100,000 person-days among people with and without IBD, respectively.After adjusting for vaccination status and history of VTE there was no difference in the risk of VTE for people with and without IBD (HR 1.08, 95%CI, 0.64 to 1.83). Conclusion(s) IBD patients with COVID-19 were not more likely to experience a VTE infection compared with the general popluation. The risk of VTE was highest soon after COVID-19 and declined thereafter. Please acknowledge all funding agencies by checking the applicable boxes below None Disclosure of Interest None Declared
ABSTRACT
Background The COVID-19 pandemic caused by the SARS-CoV-2 virus is a rapidly evolving public health emergency in which mundane behaviors such as grocery shopping or restaurant dining are considered high-risk for some, such as persons with inflammatory bowel disease (IBD) who are often immunodeficient due to medications. Research on the behavioral exposures experienced by populations with IBD during the COVID-19 pandemic are lacking. Purpose We aim to better understand how the behaviors of persons with IBD are associated with COVID-19 diagnoses. Method We conducted a prospective serosurveillance cohort study in Calgary to assess exposure to SARS-CoV-2 from Nov. 1, 2020 to Aug. 8, 2022 in 485 individuals with IBD. A diagnosis of SARS-CoV-2 was defined as a molecular-confirmed PCR test, a self-report home antigen test, or a positive nucleocapsid antibody level. Participants completed a self-report electronic questionnaire on social and occupational risk activities stratified across two time periods: Jan. 2020 to Mar. 2020 (before lockdown) and post-Jun. 2020 (post lockdown). Univariate analyses (χ2 and Fischer's exact if n≤5) were performed on social activities that occurred following the lockdown among those with IBD who were and were not diagnosed with COVID-19. Occupational exposures were compared across essential workers (EW) (i.e., frontline workers at high risk of COVID) and non-EWs. Result(s) Overall, 37.5% (n=182) of our cohort was diagnosed with COVID-19. Seniors were less likely to be infected with COVID-19 (22.7%) compared to those under the age of 65 (40.8%) (p=0.002). A greater proportion of females (42.6 %) compared to males (32.5%) were COVID positive (p=0.02). Those with Crohn's disease (38.3%) were as likely to test positive for COVID-19 as those with ulcerative colitis (36%) (p=0.65). COVID positive patients were less likely to have 4 vaccine doses (28.5%) compared to those who tested negative (71.5%) (p=0.4). Statistically significant decreases (p<0.001) in engagement post-Jun. 2020 were observed for: bar use (11.6% to 2.1%), visiting a friend (44.5% to 15.2%), having visitors over (38.7% to 12.1%), restaurant dining (38% to 9%), indoor fitness (31.9% to 8.4%), and transit use (11% to 1.3%). There was an increase in regular use of outdoor fitness (31.9% to 67.1%, p<0.003). Persons with IBD who tested positive for COVID-19 were more likely to regularly dine in a restaurant (16.8% vs. 4.7% for COVID negative, p<0.001), engage in indoor fitness activities (14% vs. 5.1%, p<0.001), and travel outside Calgary (21% vs. 11.2%, p=0.004) post-lockdown. Post-lockdown, a greater proportion of EW were COVID positive (50.4%) compared to non-EW (38.6%) (p=0.04). Image Conclusion(s) Over a two-year period, two-thirds of our cohort did not test positive for COVID-19. Those with IBD who avoided COVID tended to be older, male, have 4 doses of vaccine, and reduce their risk of exposure through social and occupational modifications, perhaps in response to public health guidance. Disclosure of Interest None Declared
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Background Throughout the COVID-19 pandemic, one of the major challenges was conveying expert health information, which was evolving rapidly, to confer population-level advice;this was especially relevant to at risk groups, such as those who are immunocompromised due to conditions like inflammatory bowel disease (IBD) or medications to manage disease. Purpose To provide sufficient information to those with IBD (>0.75% of the Canadian population or roughly 300,000 individuals) and their carers to allow self assessment of personal risks related to COVID-19. Method On March 17, 2020, Crohn's and Colitis Canada (CCC) convened the COVID-19 & IBD Taskforce comprised of adult and pediatric gastroenterologists, IBD nurses, infectious disease experts, scientists, public health officials, communication and government relations experts, and patient advisors. The taskforce met weekly (later monthly) to synthesize rapidly evolving information on COVID-19 and personal risk assessment. Expert reviews of population-level recommendations were tailored to the IBD community and communicated through website FAQs and infographics;a public-oriented burden report with foci on additional special populations (e.g., pregnant people, pediatrics, seniors), IBD medications, and mental health and access to care during the pandemic;and through a moderated, online webinar series. The 1- to 2-hour webinar recordings were then curated into 3- to 5-minute video clips to answer specific questions and uploaded to CCC's YouTube page. YouTube and website metrics show the continued efficacy of this strategy. Result(s) More than 24,778 households registered for the first 23 webinars, with more than one third registering for more than one webinar. As of April 1, 2021 (just after the 23rd webinar), there have been 54,136 views of the archived full (1- to 2-hour) webinars and a further 78,862 views of individual webinar segments (3- to 5-minute curated clips), for a total of 126,187 views. Additionally, traffic to the CCC website increased exponentially with 484,755 unique views to the COVID-19 web pages, viewed for up to 28.29 minutes. Since April 2021, after an additional seven webinars, these numbers have continued to swell to 33,243 (registrants), 81,370 (webinar views), 92,862 (segment views), and 810,156 (unique website views);this is demonstrative of the continued impact of the electronic knowledge translation strategy. Image Conclusion(s) While many within the IBD community were secluded during the early portions of the pandemic due to lockdown restrictions and public health advice not tailored to immunocompromised individuals, advice tailored to this community and presented through electronic methods proved to be an effective and efficient knowledge translation strategy. Please acknowledge all funding agencies by checking the applicable boxes below CCC Disclosure of Interest None Declared
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Background Adequate serological responses following two-dose regimens and additional doses of SARS-CoV-2 vaccination have been demonstrated for the vast majority of those with IBD. However, antibody levels following 2nd, 3rd, and 4th dose SARS-CoV-2 vaccination may decrease over time in the IBD population. Purpose We assessed the durability of serological responses to 2nd, 3rd, and 4th dose SARS-CoV-2 vaccination over time in a cohort of IBD patients. Method Adults with IBD who received at least one dose of a SARS-CoV-2 vaccine (n=559) were evaluated for serological response to the spike protein of SARS-CoV-2 using the Abbott IgG II Quant assay with a seroconversion threshold of ≥ 50 AU/mL. The geometric mean titer (GMT) with 95% confidence intervals (CI) were calculated and stratified by weeks (1–8, 8–16, 16–24, 24+ weeks) after each vaccine dose. We compared stratified GMTs with Mann–Whitney U tests using a significance level of 0.05. Result(s) Our cohort (n=559) comprised the following patient characteristics: 82.8% were 18–65 years-old (n = 463), 53.1% were female (n =297), and 71.6% had Crohn's disease (n =400). IBD medications were classified in the following mutually exclusive groups: No immunosuppressives 10.5% (n = 59), anti-TNF monotherapy 35.8% (n = 200), immunomodulatory monotherapy 2.1% (n =12 ), vedolizumab 11.8% (n =66 ), ustekinumab 20.4% (n =114 ), tofacitinib 1.2% (n =7 ), combination therapy 15.9% (n = 89), and prednisone 2.1% (n =12). For vaccine type, 85.6% and 82.3% had Pfizer for 3rd and 4th dose, respectively, while the remainder had Moderna. Seroconversion rates 1–8 weeks after 3rd and 4th dose were both 99.9%. Figure 1 compares GMTs with 95% CI by weeks after each vaccine dose. GMTs are highest 1–8 weeks after 2nd dose (4053 AU/mL;95% CI: 3468, 4737 AU/mL;n=337), 3rd dose (12116 AU/mL;10413, 14098 AU/mL;n=256), and 4th dose (14337 AU/mL;10429, 19710 AU/mL;n=67). Subsequently, antibody levels decay from 1–8 weeks to 8–16 weeks (p<0.001) for 2nd dose (mean difference: –2224 AU/mL), 3rd dose (mean difference: –7526 AU/mL), and 4th dose (mean difference: –9715 AU/mL). Compared to 16–24 weeks after 2nd dose, antibody levels 24+ weeks after were similar (GMTs: 795 AU/mL vs. 1043 AU/mL, p=0.52). For third dose, antibody levels 8–16 weeks and 16–24 weeks after vaccination were similar (4590 AU/mL vs. 4073 AU/mL, p=0.73) along with 16–24 weeks compared to 24+ weeks after vaccination (4073 AU/mL vs. 5876 AU/mL, p=0.18). Image Conclusion(s) Within 1–8 weeks after each dose of vaccine, serological responses spikes with each subsequent dose yielding a higher GMT. While antibody levels decay 8–16 weeks after each dose, similar GMT levels beyond 16 weeks may indicate durability of antibody levels over a longer duration of time. Disclosure of Interest None Declared
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Background: In August 2016 Cortiment® was approved for use in ulcerative colitis (UC) patients in Canada, but not approved for reimbursement;the Canadian Agency for Drugs and Technology in Health cited no comparable benefit for its use over other approved UC medications. Real-world data comparing Cortiment® to other UC medications is limited, especially during the COVID-19 pandemic where the use of steroids is counter-indicated for COVID-19-related outcomes. Aims: To examine the comparative risk of hospitalization, surgery, and infection after initiation of Cortiment® or oral corticosteroids among UC patients using real-world data Methods: Using population-based data from Alberta Canada, two cohorts were compared: 1. Patients dispensed Cortiment® and an ICD diagnostic code for UC [9: 556.X;10: K51.X] (August 1, 2016 to October 31, 2019);and, 2. Validated (algorithm) UC patients dispensed a >30 day supply or >500mg in 24 hours of prednisone/prednisolone (April 1, 2016 to October 31, 2019). All hospitalizations, IBD-surgery, or infections (i.e., pneumonia, c.diff, sepsis, tuberculosis) that occurred 6 or 12 months from initial medication dispensing were identified. Cox-proportional hazard models, with Hazard Ratios (HR), assessed comparative outcomes. Kaplan-Meier survival curves were created, and Poisson regression (or negative binomial) used to assess the Average Monthly Percentage Change (AMPC) with associated 95% confidence intervals (CI). Results: We identified 917 Cortiment® and 2,404 Prednisone patients. Over the study period, prednisone dispensing significantly decreased (AMPC:-2.53% [CI:-2.85,-2.21]) while Cortiment® remained stable. Dispensing of Cortiment® significantly decreased the hazard of hospitalization (all types, except surgery) at 12 months as compared to prednisone, and significantly decreased the hazard of an infection at both 6 and 12 months (Table 1, Fig 1). Conclusions: The use of Cortiment® in a real-world setting is associated with fewer deleterious outcomes, and its use during a pandemic should be preferred, especially when it's counterpart can exacerbate negative COVID-19-related outcomes. (Table Presented).
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Background: In light of the COVID-19 pandemic, gastroenterologists in Alberta moved to virtual care for many clinic visits. As the public health situation evolves, it is important to evaluate provider satisfaction with virtual care during these unprecedented times. Aims: To assess healthcare provider (HCP) satisfaction with virtual care during the COVID-19 pandemic. Methods: We administered a 20-item satisfaction survey that assessed the usefulness, ease of use, interface qualities, reliability, and overall satisfaction with virtual care tools for the delivery of care to patients with gastrointestinal diseases. One hundred and twenty-five gastroenterologists in Alberta were invited to participate via email. We used a modified Telehealth Usability Questionnaire (TUQ) which was open for response from June 19-August 30, 2020. Results: The overall response rate was 19% (24/125) with 46% female respondents. Most respondents worked in an academic facility (63%) and had been in practice for a mean duration of 12.3 years. Respondents were from seven facilities within the South, Calgary, Central and Edmonton health zones. Virtual care reported was a hybrid model consisting of telephone and in-person (54%) or telephone and video consults (42%). Although 90% indicated that virtual care tools improved access to healthcare, provided location flexibility and were appropriate to meet healthcare needs, only 42% agreed that it saved time. Inconclusive virtual consultations due to the absence of physical examination and missing lab values was reported by 75% and 33% of HCPs, respectively. Ninety-five percent of HCPs who used video conferencing found it simple, easy to learn and were able to become productive quickly with it. Over 60% of HCPs reported that virtual care (irrespective of the platform used) was not the same as in-person visits. The mean overall satisfaction for HCPs who rarely or never had virtual care prior to the pandemic, was 0.57 points higher than those who often provided virtual care (4.36 vs 3.79;95% CI: 0.26-0.88, p=0.001). Overall, 88% of providers were satisfied with virtual care and all respondents were willing to use it again (Figure 1). Identified areas of concern included patient safety, patient education on best practices, adequate remuneration, additional administrative duties, and challenges with providing care for new patients on virtual platforms. Conclusions: This survey of GI providers in Alberta showed high satisfaction and acceptance with virtual care. However, the majority reported it to be less reliable than in-person visits. Access to Alberta Netcare to view investigations was deemed valuable. Areas of concern that needs to be addressed include patient education on virtual care best practices and provider resources to assist with new consultations on virtual platforms.
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Background: The COVID-19 pandemic is affecting patients and healthcare providers worldwide. During the first wave of the pandemic, healthcare delivery shifted from in-person to virtual clinics. Non-urgent and some emergent procedures, including endoscopies, surgeries, and imaging, were delayed to limit the spread and divert resources to COVID-19. Aims: To assess the impact of the COVID-19 pandemic in care to IBD patients Methods: A survey study was conducted to assess the impact of the COVID-19 pandemic on IBD care. All patients had a virtual clinic appointment between March to July 2020 at either: University of Alberta Hospital or the University of Calgary Clinic. A section of the survey assessed patient experience of virtual clinics and delays in access to IBD care during the COVID-19 pandemic. Results: A total of 1581 patients were contacted to complete the survey. 628 patients agreed to participate in the survey, however not all patients completed each component. The mean age of patients who participated in the survey was 48 years (SD = 15.19). 408 patients responded to satisfaction/future use questions: 84.3% (344) patients agree/strongly agree they were comfortable communicating to the physician using the remote system, 77.5% (316) of patients agree/strongly agree that virtual clinic is an acceptable way to receive healthcare services, 84.8% (346) of patients agree/strongly agree they would use virtual care services again, and 82.6% (337) agree/strongly agree they were satisfied with the telehealth system. Additional challenges were reported by 228 patients. Fear and stress (infection risk/mental health concerns/unemployment) was reported by 57.4% (131) patients. Access to healthcare services, PPE, and community resources was a challenge experienced by 26.3% (60) patients. Additionally, 16.2% (37) patients experienced uncertainty around IBD-specific care, including procedures, treatments, labs, and medications. Overall, 17.3% of patients reported some type of delay in care by July 2020. Table 1 shows the proportion of patients with a delay by type of care and the median delay: 5.7% of patients with IBD had surgery delayed by a median of 10 weeks (8-16 weeks). Conclusions: While some delays in healthcare delivery occurred during the first wave of the pandemic, overall 82.7% of patients with IBD maintained their care without disruption. Sustaining healthcare delivery to the IBD community required adaptation to virtual care;however, patient satisfaction was overwhelming positive among patients with IBD.
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Background: The immune response of SARS-CoV-2 vaccines is uncertain in those with Inflammatory Bowel Disease (IBD) due to a diverse array of immune-modifying therapies that vary in the mechanism of immunosuppression. Aim: We aimed to quantify the serological response to SARS-CoV-2 vaccines in those with IBD and determine antibody levels across varying therapeutic options. Methods: Individuals with IBD who received a first and/or second dose of a COVID-19 vaccine (Pfizer-BioNTech, Moderna, and/or AstraZeneca) were assessed for serological response (1–8 weeks after first dose;1–8 weeks after second dose, 8–18 weeks after second dose, 18+ weeks after second dose) using the SARS-CoV-2 IgG II Quant assay to the receptor-binding domain of the SARS-CoV-2 spike protein. The cohort was stratified based on age, sex, vaccine received, IBD type, IBD therapeutic, and prior confirmed diagnosis of COVID-19. The primary outcome was seroconversion defined as IgG levels of ³50 AU/mL. Secondarily, we evaluated the geometric mean titer (GMT) with 95% confidence intervals (CI). Results: Table 1 describes the characteristics of individuals with IBD (n=466) with serological data following the first dose (n=247) and/or second dose (n=413) of a COVID-19 vaccine. After 1–8 weeks following first dose of the vaccine, 81.4% seroconverted, with the lowest first-dose conversion rates in patients taking anti- TNF monotherapy (80.3%), anti-TNF combination therapy (51.5%), and corticosteroids (50.0%) (Table 1). Overall, 98.4% of the cohort seroconverted within 1–8 weeks of the second dose. Over time, seropositive rates decreased with 95.8% seroconversion within 8– 18 weeks of the second dose and 90.5% after 18 weeks. Seroconversion after second dose was consistently high across all medication classes (range: 94.6%–100.0%), except for oral corticosteroids (62.5%). GMT levels significantly increased (p<0.0001) from first dose (1825 AU/mL [95% CI: 981, 2668 AU/mL]) to second dose at 1–8 week (9059 AU/mL [7698, 10420 AU/mL]) but fell significantly (p<0.0001) to 3649 AU/mL (95% CI: 2562, 4736 AU/ mL) 8–18 weeks from second dose and 2527 AU/mL (95% CI: 883, 4172 AU/mL) 18+ weeks after second dose (Table 1, Figure 1). GMT levels 1–8 weeks after second dose were higher in those with prior COVID-19 (16,770 AU/mL), but lower in those receiving anti- TNF combination therapy (4231 AU/mL) and oral corticosteroids (5996 AU/mL) (Table 1). Conclusion: Seroconversion rates following full-regimen vaccination are high in patients with inflammatory bowel disease across all medication classes except for anti-TNF combination therapy and oral corticosteroids. Antibody titres and seroconversion rates tend to decrease after eight weeks post-full vaccination, which is consistent across medication classes. (Table Presented) Table 1. Patient and vaccine characteristics, seroconversion rates, and geometric mean titres by prior PCR-confirmed COVID-19 status for each medication class. (Figure Presented) Figure 1. Log-transformed anti-SARS-CoV-2 spike antibody concentration per vaccine category. Black points represent GMTs while narrow black bars represent bounds of 95% CI associated with each GMT. Solid blue line represents threshold for positive seroconversion [ln (50 AU/mL)].
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Background: The immune response to a two-dose regimen of SARS-CoV-2 vaccination in those with Inflammatory Bowel Disease (IBD) has been consistently high in emerging research. Serological responses following a third dose have yet to be established. Aim: We aimed to quantify the serological response to a third dose of SARS-CoV-2 vaccines in those with IBD and compare to responses after a two-dose regimen. Methods: Individuals with IBD who have received at least two doses of a COVID-19 vaccine were assessed for serological response using the SARS-CoV-2 IgG II Quant assay to the receptor-binding domain of the SARSCoV- 2 spike protein at least eight weeks after second dose and then after third dose. The primary outcome was seroconversion defined as IgG levels of ≥50 AU/mL. Secondarily, we evaluated the geometric mean titer (GMT) with 95% confidence intervals (CI). Outcomes were stratified by prior COVID-19 history. A Wilcoxon rank sum test was used to compare antibody titres following 3rd dose vaccination and titres following 2nd dose vaccination. For patients with both post-2nd and post-3rd vaccination serology, the difference in antibody titres between doses was determined and the mean difference was tested using one-sample Student's t-tests. Results: Table 1 describes the characteristics of individuals with IBD (n = 271) with serological data following the corresponding dose for those with 2nd dose vaccination (n = 175) compared to those with a 3rd dose of vaccine (n = 96). Seroconversion following 3rd dose vaccination occurred for all individuals (100.0%), compared to a 94.4% seroconversion rate at least eight weeks following 2nd dose vaccination (range: 8 to 35 weeks post-2nd dose). GMT for the post-3rd dose cohort (16424 AU/mL [13437, 19411 AU/mL]) was significantly higher (p<0.0001) than the post-2nd dose cohort (3261 AU/mL [2356, 4165 AU/mL] (Table 1, Figure 1b). Individual titres as a function of time following 2nd dose vaccination are seen in Figure 1a for both 3rd dose and 2nd dose cohorts. For individuals with serology following both 2nd dose and 3rd dose vaccination (n = 82), seroconversion rates increased from 97.6% to 100.0% after the 3rd dose. GMT following post-3rd dose vaccination also increased with a mean difference in antibody titres between post-3rd dose and post-2nd dose vaccination of 11384 AU/mL (8541, 14228 AU/mL, p < 0.0001). This difference was significant for both individuals with prior COVID-19 history (11682 AU/mL [95% CI: 8618, 14746 AU/mL, p<0.0001]) and individuals without (8194 AU/mL [95% CI: 988, 15400 AU/mL]). Conclusion: Seroconversion rates and antibody response following third dose vaccination are substantially increased as compared to second dose in patients with IBD. Third dose vaccination can counter the decrease in antibody concentration over time following a two-dose regimen. (Table Presented) Table 1. Patient characteristics, vaccine type, seroconversion rates, and geometric mean titres by prior COVID-19 status for post-3rd dose and post-2nd dose cohorts
ABSTRACT
BACKGROUND: The immune response of SARS-CoV-2 vaccines is uncertain in those with Inflammatory Bowel Disease (IBD) due to a diverse array of immune-modifying therapies that vary in the mechanism of immunosuppression. AIM: We aimed to quantify the serological response to SARS-CoV-2 vaccines in those with IBD and determine antibody levels across varying therapeutic options. METHODS: Individuals with IBD who received first and/or second dose of a COVID- 19 vaccine (Pfizer-BioNTech, Moderna, and/or AstraZeneca) were assessed for serological response (2-4 weeks after first dose;2-8 weeks after second dose and 8-18 weeks after second dose) using the SARS-CoV-2 IgG II Quant assay to the spike protein of SARS-CoV-2. The cohort was stratified based on age, sex, vaccine received, IBD type, IBD therapeutic, and prior confirmed diagnosis of COVID-19. The primary outcome was seroconversion defined as IgG levels of ≥50 AU/mL. Secondarily, we evaluated the geometric mean titer (GMT) with 95% confidence intervals (CI). RESULTS: Table 1 describes the characteristics of individuals with IBD (n=464) with serological data following the first dose (n=266) and/or second dose (n=303) of a COVID-19 vaccine. After the first dose of the vaccine, 81.6% seroconverted, with the lowest first-dose conversion rates in patients taking anti-TNF monotherapy (79.7%), anti-TNF combination therapy (52.9%), and corticosteroids (50.0%) (Table 1). Overall, 98.4% of the cohort seroconverted within 2-8 weeks of the second dose, with 94.6% seropositive within 8-18 weeks of the second dose. Seroconversion after second dose was consistently high across all medication classes (range: 94.6%-100.0%), except for oral corticosteroids (62.5%). GMT levels significantly increased (p<0.0001) from first dose (1679 AU/mL) to second dose at 2-8 week (7943 AU/mL) but fell significantly (<0.0001) to 3565 AU/mL 8-18 weeks from second dose (Table 1, Figure 1). GMT levels 2-8 weeks after second dose were higher in those with prior COVID-19 (12,729 AU/mL), but lower in those receiving anti-TNF combination therapy (4231 AU/mL) and oral corticosteroids (5996 AU/mL) (Table 1). CONCLUSION: Seroconversion rates following fullregimen vaccination are high in patients with inflammatory bowel disease across all medication classes except for anti-TNF combination therapy and oral corticosteroids. Antibody titres and seroconversion rates tend to decrease after 8 weeks postfull vaccination, which is consistent across medication classes.
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Background: As the COVID-19 pandemic continues, there are questions about whether patients with celiac disease (CD) are at increased risk for severe outcomes. Prior studies have shown that patients with CD have a higher risk of developing zoster and complications from influenza and pneumococcal pneumonia, risks that persist after adoption of the gluten free diet. To study the outcomes of COVID-19 in patients with celiac disease, we created a secure, online, de-identified adult and pediatric reporting registry. Methods: The SECURECeliac registry (www.covidceliac.org) was established on March 31, 2020 and promoted via physician email lists, national societies, and word-of-mouth. Clinicians worldwide are encouraged to report all cases of COVID-19 in patients with celiac disease, regardless of severity. (Only confirmed cases of COVID-19, either through viral PCR swab or serology testing, are eligible to be reported in the registry.) Clinicians were counseled to report confirmed cases only after a minimum of 7 days and sufficient time had passed to observe the disease course through resolution of acute illness or death. A choropleth map to illustrate geographic differences in reported cases of COVID-19 in those with CD was created using QGIS and an interactive online website was created using ARCGIS to visualize current data by time, country, age, sex, hospitalizations, and deaths. Results: Between March 31, 2020 and November 20, 2020, there have been 84 cases of COVID-19 reported in patients with celiac disease. Countries across five continents are represented in the registry: Asia, Australia, Europe, North America and South America (Figure 1). 86% of patients (N = 72) did not require hospitalization for COVID-19 while 14% did (N = 12). 1% of patients (N = 1) required ICU-level care while 1% of patients (N = 1) died from COVID-19. Patients who were hospitalized tended to be older (45.8y vs 39.4y, p= 0.2) and have at least one comorbidity (50.0% vs 31.9%, p= 0.3). Patients who were hospitalized were also less likely to adhere to a strict gluten-free diet (41.7% vs 65.3%, p=0.2). Patients with gastrointestinal symptoms were more likely to be hospitalized (66.7% vs 31.9%, p = 0.03). An online dashboard with interactive map displaying the current global distribution of patients with CD and COVID-19 is found here: www.covidceliac.org/map Conclusions: Preliminary data from the SECURECeliac registry does not suggest increased risk of severe outcomes in patients with celiac disease who contract COVID-19. Gastrointestinal symptoms were associated with hospitalization for COVID-19. The registry remains open for clinicians to contribute to this reporting system so as to better define the impact of COVID-19 on patients with celiac disease and how factors such as age, comorbidities, and treatments impact COVID-19 outcomes.(Image Presented)(Table Presented)
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Background: Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is an international database that monitors COVID-19 outcomes in IBD patients. We examined the influence of IBD disease activity on COVID-19 severity, while accounting for confounders and exploring the modifying effect of age. Methods: This was a retrospective analysis of all cases reported to SECURE-IBD with complete Physician Global Assessment (PGA) of IBD activity and age data (N=3028). PGA was categorized as remission/mild (reference) vs moderate vs severe. Outcomes used as surrogates of severe SARS-CoV2 infection were hospitalization and a composite of ICU/ ventilation/death. We compared cohort characteristics across PGA categories using the Chisquare and Kruskal-Wallis test. Using logistic regression, we determined the unadjusted association between disease activity and COVID-19 outcomes, overall and by age decade. Multivariable logistic regression models included PGA, age, sex, IBD type, comorbidities (0, 1, ≥2) and systemic corticosteroids (CS) a priori and additional confounders if they changed the estimate by ≥10% (we tested BMI, race, and medications). Risk estimates were expressed as crude and adjusted odds ratios (OR) with 95% CI. We also built models stratified by age (≤50 vs >50 years). Results: Race, IBD type, BMI and current medications (CS, anti-TNF, thiopurine monotherapy, aminosalicylates, ustekinumab and tofacitinib) differed across PGA categories (p<0.05). COVID-19 was more severe in patients with more active IBD: hospitalization rates 19% (remission/mild), 26% (moderate) and 45% (severe);ICU/ventilation/death rates 5% (remission/ mild), 6% (moderate) and 12% (severe) (p<0.05 for both outcomes). In unadjusted analyses, higher PGA was associated with an increased risk of hospitalization (moderate: OR 1.52, 95% CI 1.21-1.92;severe: OR 3.57, 95% CI 2.56-4.98) and ICU/ventilation/death (moderate: OR 1.40, 95% CI 0.94-2.10;severe: OR 2.72, 95% CI 1.63-4.55). Figure 1 illustrates the OR for hospitalization and ICU/ventilation/death for severe PGA vs remission/ mild by decade;effect sizes are greatest in patients ≤50 years. In multivariable analyses, PGA remained significantly associated with hospitalization, but not ICU/ventilation/death (effect lost after adjusting for CS) (Table 1). However, in analyses stratified by age, PGA remained significantly associated with both hospitalization and ICU/ventilation/death, even after adjusting for medications, in patients ≤50 but not >50 years (Table 1).Conclusions: The association between IBD activity and severe COVID-19 varied with age. The association was stronger in younger patients and, after adjusting for the confounding effect of medications, particularly CS, disease activity was significantly associated with severe outcomes only in younger (≤50 years) patients.(Figure Presented)Odds Ratios for A) hospitalization and B) ICU/ventilation/death for severe PGA vs remission/mild by decade (Table Presented)Adjusted Odds Ratios for Hospitalization and ICU/ventilation/death by Disease Activity, Overall and Stratified by Age
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Background: Cases of Coronavirus disease 2019 (COVID-19) have emerged in discrete waves across different regions in the world. We explored temporal trends in the reporting of COVID-19 in patients with inflammatory bowel disease (IBD), in a large global database. Methods: The Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is an international registry to study the character-istics and outcomes of patients with IBD diagnosed with COVID-19. Joinpoint regression models calculated the average percent change (APC) with 95% confidence intervals (CI) in weekly reported cases of COVID-19 in patients in the registry stratified by geographic regions (Asia, Europe, Latin America, and North America) during two time periods: March 22 to September 12 and September 13 to November 14, 2020. We also determined the APC in US regions (Midwest, Northeast, South and West) during the two time periods. Results: Across 63 countries and dependencies, 3,195 cases of COVID-19 in people with IBD were reported over an 8-month period. Overall, COVID-19 reporting steadily decreased throughout the world by 4.5% per week (95% CI: −5.7, −3.2) from March 22 to September 12, 2020 but then steadily climbed by 12.4% per week (95% CI: 6.8, 18.3) from September 13 to November 14, 2020. After stratification by geographic region, weekly reporting declined before September 13 in North America (APC = −2.0%;95% CI: −3.7, −0.4), Asia (APC =− 4.4%;95% CI: −7.8, −0.9), and Europe (APC = −8.6%;95% CI: −10.6, −6.6), but escalated in Latin America (APC = 3.4%;95% CI: 0.7, 6.1) (Figure 1). After September 12, the rate of weekly cases decreased in Latin America (APC = −19.0%;95% CI: −33.3, −1.7) and Asia (APC = −19.3%;95% CI: −34.6, −0.5), while increased in North America (APC = 10.7%;95% CI: 4.3, 17.4) and Europe (APC = 28.0%;95% CI: 17.3, 39.6) (Figure 1). Within the US, temporal trends differed by region: Midwest (stable APC: −0.8%;95% CI: −3.5, 1.9 then increase APC: 27.3%;95%: 16.1, 39.6), Northeast (decrease APC: −9.1%;95% CI:− 11.8, −6.2 then stable APC: 2.4%;95% CI: −9.9, 16.5), South (increase APC: 5.3%;95%CI: 2.5, 8.3 then decrease APC: −12.0;95% CI: −18.4, −5.0), and West (stable APC: 0.2%;95% CI: −3.0, 3.5 then stable APC: 9.0%;95% CI: −13.8, 37.9) (Figure 2). Conclusion: COVID-19 reporting to SECURE-IBD declined steadily during the first wave of the pandemic throughout the world except Latin America. Starting in September, reports to SECURE-IBD rose in both Europe and North America, consistent with the second wave of the pandemic in these countries.(Figure presented)Figure 1. Global regional temporal trends in reporting of COVID-19 in patients with IBD from the SECURE-IBD registry: A. Asia, B. Europe, C. Latin America, and D. North America: March 22–28 to September 6-12 and September 13-19 to November 8–14, 2020(Figure presented)Figure 2. United States regional temporal trends in reporting of COVID-19 in patients with IBD from the SECURE-IBD registry: A. Midwest, B. Northeast, C. South, and D. West: March 22–28 to September 6-12 and September 13-19 to November 8–14, 2020
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BACKGROUND The COVID-19 pandemic is affecting patients and healthcare providersworldwide. During the first wave of the pandemic, healthcare delivery shifted from inpersonto virtual clinics. Non-urgent and some emergent procedures, including endoscopies,surgeries, and imaging, were delayed to limit the spread and divert resources to COVID-19. AIMS To assess the impact of the COVID-19 pandemic in care to IBD patients METHODSA survey study was conducted to assess the impact of the COVID-19 pandemic on IBDcare. All patients had a virtual clinic appointment between March to July 2020 at either:University of Alberta Hospital or the University of Calgary Clinic. A section of the surveyassessed patient experience of virtual clinics and delays in access to IBD care during theCOVID-19 pandemic. RESULTS A total of 1581 patients were contacted to complete thesurvey. 628 patients agreed to participate in the survey, however not all patients completedeach component. 423 patients reported which hospital they receive their care: 71.2% (301)were from the University of Alberta, 24.6% (104) were from the University of Calgary, and2.9% (18) did not list either hospital. 429 patients provided a postal code, where 71.8%(308) were from either the Calgary or Edmonton metropolitan area. The mean age of patientswho participated in the survey was 48 years (SD = 15.19). 408 patients responded tosatisfaction/future use questions: 84.3% (344) patients agree/strongly agree they were comfortablecommunicating to the physician using the remote system, 77.5% (316) of patientsagree/strongly agree that virtual clinic is an acceptable way to receive healthcare services,84.8% (346) of patients agree/strongly agree they would use virtual care services again, and82.6% (337) agree/strongly agree they were satisfied with the telehealth system. Table 1shows additional challenges experienced by patients. Overall, 17.3% of patients reportedsome type of delay in care by July 2020. Table 2 shows the proportion of patients with adelay by type of care and the median delay: 5.7% of patients with IBD had surgery delayedby a median of 10 weeks (8-16 weeks). Of note, 73.9% (51) of patients were from theUniversity of Alberta, 23.2 (16) were from the University of Calgary, and 2.9% (2) patientsdid not associate with either hospital. Additionally, 75.4% (52) of patients who experienceddelays live within the Calgary/Edmonton metropolitan area. CONCLUSION: While somedelays in healthcare delivery occurred during the first wave of the pandemic, overall 82.7%of patients with IBD maintained their care without disruption. Sustaining healthcare deliveryto the IBD community required adaptation to virtual care;however, patient satisfaction wasoverwhelming positive among patients with IBD.(Table Presented)Table 1: Additional Challenges Experienced by Patients (N = 228)(Table Presented)Table 2: Proportion of IBD Patients with delays in care (N=398)
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Introduction In the United States (US), race and ethnicity impact outcomes of chronic diseases including inflammatory bowel disease (IBD). The aim of this study was to evaluate racial and ethnic disparities in the coronavirus disease 2019 (COVID-19) outcomes among IBD patients and to assess the degree to which observed disparities may be attributed to non-IBD comorbidities. Methods Using data from the Surveillance of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD), an international, collaborative registry of IBD patients with confirmed COVID-19, we used multivariable logistic regression to evaluate associations between race and ethnicity and COVID-19 outcomes. These included hospitalization and severe COVID-19 defined as a composite of intensive care unit stay, mechanical ventilation and/or death. Results We analyzed 988 US cases (96 [9.7%] Hispanic;141 [14.3%] non-Hispanic Black;680 [68.8%] non-Hispanic White). Bivariate analyses of outcomes are reported in the Table. Compared to non-Hispanic White patients, Hispanic patients had higher odds of hospitalization [adjusted odds ratio (aOR) 2.01, 95% CI 1.07 to 3.79] but not severe COVID-19 (2.75, 95% CI 0.93 to 8.10). Compared to non-Hispanic White patients, non-Hispanic Black patients had higher odds of hospitalizations (aOR 2.47, 95% CI 1.48 to 4.11) and severe COVID-19 (2.50, 95% CI 1.01 to 6.20) after adjusting for age, sex, and IBD activity (Figure). Upon adjusting for comorbidities, the odds of hospitalization and severe COVID-19 remained unchanged in Hispanic individuals compared to non-White Hispanic individuals (aOR 2.14, 95% CI 1.09 to 4.18 for hospitalizations and 2.69, 95% CI 0.77 to 9.38 for severe COVID-19), but decreased in Black individuals compared to non-White Hispanic individuals (aOR 2.21, 95% CI 1.30 to 3.76 for hospitalization and 2.13, 95% CI 0.81 to 5.59 for severe COVID-19). Conclusions The odds of adverse COVID-19 outcomes are higher in Hispanic and non-Hispanic Black, compared with non-Hispanic White individuals with IBD, accounted for partially by underlying comorbidities. (Table presented) COVID-19 Outcomes for United States cases reported to SECURE-IBD, overall and stratified by race/ethnicity (Figure presented) Odds ratios of A) hospitalization due to COVID-19 and B) severe COVID-19 outcomes (ICU stay, mechanical ventilation or death) among Hispanic vs. non-Hispanic White individuals and among non-Hispanic Black vs. non-Hispanic White individuals
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Objective: We assessed our knowledge about the epidemiological, clinical characteristics, laboratory/radiological findings, and outcomes of hospitalized children with COVID-19. Materials and Methods: This retrospective single-center study was conducted on 54 children with COVID-19 who were hospitalized from March 16, 2020, to April 26, 2020, in the Pediatric Department at Sancaktepe Training &Research Hospital Istanbul, Turkey.
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Introduction: During the 2019 novel coronavirus (COVID-19) pandemic period, all cases admitted to the emergency services have been evaluated primarily for COVID-19, and therefore other infectious diseases, especially Crimean Congo Hemorrhagic Fever (CCHF), which are endemic in our region, can be overlooked. In this study, it was aimed to determine the diagnostic power of the Hitit Index, which we developed from a panel consisting of clinical and laboratory findings of the cases with and without CCHF in previous years, to distinguish CCHF cases from COVID-19 cases. Materials and Methods: The study groups consisted of the COVID-19 cases (n= 116) admitted to the emergency service and the CCHF patients (n= 110) who were followed up in the Infectious Diseases and Clinical Microbiology Clinic of the same hospital between 2015-2020. Results: Hitit Index was found to be statistically significantly higher in patients with CCHF. For Hitit Index, sensitivity and specificity were 88% and 99%, while negative predictive value (NPV) and positive predictive value (PPV) were 90% and 99%, respectively. Conclusion: The Hitit Index is an example of artificial intelligence that we can use to distinguish patients with CCHF from patients with COVID-19.