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Background During the COVID-19 pandemic, the focus of many health care systems shifted in order to prioritize and allocate resources toward treating those affected by COVID-19. What this has meant for other patient populations remains unclear. We aimed to determine if there have been changes to acute care access for patients with inflammatory bowel disease (IBD) during the COVID-19 pandemic. Methods A retrospective cohort study was performed in IBD patients seen during (March 1, 2020 to August 31, 2020) and before (March 1, 2019 to August 31, 2019) the COVID-19 pandemic. IBD-related emergency room (ER) access, hospitalization, inpatient care and follow-up and post-discharge ER access were assessed. Results A total of 1229 participants were included. A higher proportion of patients accessed ER during the pandemic (44.6% versus 37.2%, P = 0.0097). A higher proportion of hospitalizations resulted from IBD-related ER visits during the pandemic period (41.6% versus 32.4%, OR = 1.48, 95% CI = 1.14 to 1.94, P = 0.0047), though length of stay was shorter (7.13 ± 8.95 days versus 10.11 ± 17.19 days, P = 0.015) and use of rescue infliximab was less. No change was seen in inpatient surgical intervention. Despite similar proportions of follow-up appointments post-hospital discharge (pre-pandemic, 77.9% versus pandemic, 78.3%), more ER visits occurred in the first 30 days following hospitalization for patients in the pandemic cohort (24.4% versus 11.1%, P = 0.0015). Conclusion These data highlight the need for ER services and hospitalization amongst IBD patients during the COVID-19 pandemic. This suggests that a return to pre-pandemic IBD care infrastructure is needed to mitigate the need for acute care access.

Background The management of inflammatory bowel disease (IBD) requires frequent endoscopic assessment. It is unknown if measures put in place to reduce the spread of the virus SARS-CoV-2, including the delay of non-urgent patient assessments, resulted in deleterious outcomes for patients with IBD. Therefore, we aimed to determine if delays in endoscopy during the COVID-19 pandemic were associated with an increased risk of adverse IBD outcomes (emergency room, ER presentation, hospitalization, surgery, or escalation of drug therapy). Methods A retrospective cohort study was performed in patients with IBD scheduled for outpatient endoscopies between March and August 2019 and 2020 at two tertiary care centers affiliated with Western University, London, Canada. Data pertaining to endoscopy timing, IBD drug prescription, ER attendance, hospitalization, and surgery were collected. Results A total of 1160 endoscopies (2019, n = 718; 2020, n = 442) occurred during the study periods in 669 (2019) and 414 (2020) patients with IBD, respectively. More endoscopies were delayed in 2020 than 2019 (26.7% vs. 9.7%, respectively, P < 0.0001). Endoscopy delay was not associated with an increased risk of an adverse IBD outcome (OR = 1.23, 95%CI = 0.89–1.34, P = 0.20). Fewer adverse IBD outcomes were seen in the 2020 cohort who had endoscopy delays (n = 33/115, 28.7%) versus those without delay (n = 176/299, 58.9%, P < 0.0001). Conclusion More endoscopy delays occurred during the COVID-19 pandemic; however, delays in general were not associated with adverse IBD outcomes, and in particular, endoscopy delays during the COVID-19 pandemic were associated with fewer deleterious IBD outcomes, suggesting that patients with IBD in need of urgent endoscopy were appropriately identified.

The prevalence of inflammatory bowel diseases (IBD), Crohn’s disease and ulcerative colitis, in Canada, is over 0.75% in 2021. Many individuals with IBD are immunocompromised. Consequently, the World Health Organization’s declaration of a global pandemic uniquely impacted those with IBD. Crohn’s and Colitis Canada (CCC) formed the COVID-19 and IBD Taskforce to provide evidence-based guidance during the pandemic to individuals with IBD and their families. The Taskforce met regularly through the course of the pandemic, synthesizing available information on the impact of COVID-19 on IBD. At first, the information was extrapolated from expert consensus guidelines, but eventually, recommendations were adapted for an international registry of worldwide cases of COVID-19 in people with IBD. The task force launched a knowledge translation initiative consisting of a webinar series and online resources to communicate information directly to the IBD community. Taskforce recommendations were posted to CCC’s website and included guidance such as risk stratification, management of immunosuppressant medications, physical distancing, and mental health. A weekly webinar series communicated critical information directly to the IBD community. During the pandemic, traffic to CCC’s website increased with 484,755 unique views of the COVID-19 webpages and 126,187 views of the 23 webinars, including their video clips. CCC’s COVID-19 and IBD Taskforce provided critical guidance to the IBD community as the pandemic emerged, the nation underwent a lockdown, the economy reopened, and the second wave ensued. By integrating public health guidance through the unique prism of a vulnerable population, CCC’s knowledge translation platform informed and protected the IBD community.

At the beginning of the coronavirus disease 2019 (COVID-19) pandemic, there were many unknowns: transmission vectors of the virus, appropriate intervention strategies and if being immunocompromised due to inflammatory bowel disease (IBD), for example, or medications put a person at increased risk for severe COVID-19. Imposing and relaxing of public health restrictions at different times and in different regions in Canada led to different epidemiologies of the virus in different provinces and territories. In order to understand the waxing and waning of waves of the COVID-19 pandemic, it is necessary to understand the effective reproductive number (Rt) and the countervailing forces that exert upward or downward pressure on the spread of the virus at a given point in time. As many regions in Canada deal with a third wave, the primary forces affecting the Rt of severe acute respiratory syndrome coronavirus 2 are variants of concern and the increasing vaccinations of Canadians leading to increased population-level immunity. Fortunately, for the IBD population, current research suggests that those with IBD are not at increased risk of contracting COVID-19, nor of having a more severe disease course when compared to the general population.

Crohn’s disease (CD) is associated with reduced quality of life, increased absenteeism and high direct medical costs resulting from frequent hospitalizations and surgeries. Tumor necrosis factor–alpha inhibitors (TNFi’s) have transformed the therapeutic landscape and enabled a shift from a symptom control to a treat-to-target strategy. The Effect of Tight Control Management on Crohn’s Disease (CALM) trial demonstrated tight control (TC), with TNFi dose changes informed by biochemical markers of inflammation, achieved higher mucosal healing rates compared with conventional management (CM) based on symptoms. A Markov model compared TC and CM strategies from the perspective of the Canadian public payer using patient-observation data from the CALM trial. A regression model estimated weekly CD Activity Index–based transition matrices over a 5-year horizon and included covariates to improve extrapolation of outcomes beyond the 48-week trial assessment period. Costs of CD-related hospitalizations, biomarker tests and adalimumab injections were sourced from public data. Other direct medical costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated. Absenteeism was monetized and included in a sensitivity analysis. Over the 5-year time horizon, TC reduced hospitalization costs by 64% compared with CM. Other direct medical costs were reduced by 22%; adalimumab costs increased by 38%, generating an ICER of $35,168 per QALY gained. Absenteeism costs were reduced by 54%, and, when that was included in the model, TC became dominant compared with CM. Management of CD with TC is cost-effective compared with CM in Canada and is dominant if indirect costs associated with absenteeism are included. Trial registration number: NCT01235689.

Persons with inflammatory bowel disease (IBD) make up more than 0.75% of the Canadian population in 2021. Early in the COVID-19 pandemic, individuals with IBD, particularly those on immunosuppressive therapies, were concerned that their health status may place them at higher risk of contracting COVID-19 or experiencing more severe disease course if infected with SARS-CoV-2. In response, Crohn’s and Colitis Canada developed the COVID-19 and IBD Taskforce in March 2020 to rapidly synthesize the evolving knowledge of COVID-19 as relevant to Canadians with IBD. The Taskforce communicated expert information directly to the Canadian IBD community through online tools and a webinar series. In order to understand the full impact of COVID-19 on the IBD community, Crohn’s and Colitis Canada commissioned a policy report that was informed through a systematic literature review and synthesized across working groups along the following domains: Epidemiology, Children and Expectant Mothers with IBD, Seniors with IBD, Mental Health, Risk Factors and Medications, Vaccines, and Healthcare Delivery during the Pandemic and the Future Model of IBD Care. This report from Canadian physicians, researchers, and IBD community representatives highlights the physical, mental, and health systems impact of COVID-19 on the entire spectrum of the IBD community, including children, adolescents, adults, seniors, and pregnant people with IBD. This executive summary provides an overview of the crucial information from each of the chapters of the policy report, supplemented with additional information made available through Crohn’s and Colitis Canada’s webinar-based knowledge translation platform.

Background & Aims Crohn’s disease (CD) is a lifelong illness with substantial morbidity, although new therapies and treatment paradigms have been developed. We provide guidance for treatment of ambulatory patients with mild to severe active luminal CD. Methods We performed a systematic review to identify published studies of the management of CD. The quality of evidence and strength of recommendations were rated according to the Grading of Recommendation Assessment, Development and Evaluation (GRADE) approach. Statements were developed through an iterative online platform and then finalized and voted on by a group of specialists. Results The consensus includes 41 statements focused on 6 main drug classes: antibiotics, 5-aminosalicylate, corticosteroids, immunosuppressants, biologic therapies, and other therapies. The group suggested against the use of antibiotics or 5-aminosalicylate as induction or maintenance therapies. Corticosteroid therapies (including budesonide) can be used as induction, but not maintenance therapies. Among immunosuppressants, thiopurines should not be used for induction, but can be used for maintenance therapy for selected low-risk patients. Parenteral methotrexate was proposed for induction and maintenance therapy in patients with corticosteroid-dependent CD. Biologic agents, including tumor necrosis factor antagonists, vedolizumab, and ustekinumab, were recommended for patients failed by conventional induction therapies and as maintenance therapy. The consensus group was unable to clearly define the role of concomitant immunosuppressant therapies in initiation of treatment with a biologic agent. Conclusions Optimal management of CD requires careful patient assessment, acknowledgement of patient preferences, evidence-based use of existing therapies, and thorough assessment to define treatment success.

Background The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak, also known as COVID-19, was declared a worldwide pandemic in March of 2020. Since the onset of the pandemic, the focus of many healthcare systems has shifted toward limiting non-essential visits to hospitals in order to prioritize and allocate resources toward treating those affected by COVID-19, and preventing further exposures. While the effect of COVID-19 has been felt amongst many patient populations, those with inflammatory bowel disease (IBD) have been particularly impacted through delayed appointments and endoscopy, which is critical in disease monitoring. Aims We aimed to determine how changes to the provision of IBD care due to the COVID-19 pandemic have affected IBD patients. Methods A retrospective cohort study was conducted using administrative data comparing IBD patients admitted to the gastroenterology ward from March 17 to August 31 2019, with IBD patients admitted from March 17 to August 31 2020 at a tertiary care centre in London, Ontario. Patients were reviewed to assess differences in care utilization and IBD-related outcomes such as hospitalization, surgery and length of stay and in-patient drug therapy. Results A total of 538 patients (259 in 2019 cohort and 279 in 2020 cohort) were reviewed with 48 and 60 IBD patients meeting the inclusion criteria for 2019 and 2020 respectively. Patient demographics were similar between 2019 and 2020 cohort for age, sex, rurality, disease type, and biologic exposure. A greater proportion of patients were admitted with IBD flares in 2020 (86.7% vs 75%, p=0.03). Furthermore, the 2020 cohort also had a 45% increase in in-patient surgical consultations (p=0.07), a 50% increase in in-patient IBD-related surgeries (p=0.39), a 69% increase in inpatient Remicade prescription (p=0.13) and a 70% increase in infectious complications at presentation to hospital (p=0.21). A shorter median length of stay was reported for patients in the 2020 cohort (4 days IQR 3.95 vs 5.85 IQR 4.65, p=0.09). Conclusions Preliminary data suggest that during the COVID-19 pandemic, we have seen more deleterious outcomes in our IBD patients such as increased flares necessitating hospital admission. There was also a non-significant trend toward increased infectious complications as well as in-patient surgeries and need for in-patient Remicade. Though these results cannot be fully interpreted due to the need for further sampling, they suggest that IBD patients may be at-risk for poor outcomes in the current climate of medical care. Completion of this study will help define the full impact of care shifts related to reducing the spread of the novel coronavirus on IBD patients and highlight areas of care that need careful assessment and consideration to protect IBD patient health. Funding Agencies None

Background Non-melanoma skin cancer (NMSC) accounts for at least 40% of all new cancer diagnoses in Canada annually and presents a significant cost to the health care system due to the volume of cases. The incidence of NMSC in patients with Inflammatory Bowel Disease (IBD) is higher when compared to the general population. Generally, in a non-IBD population, the risk of further NMSC progression is low, however, little data exists that highlights differences in clinical course of patients diagnosed with NMSC who have IBD and are TNF-α antagonist exposed. It is unclear if TNF-α antagonist therapy should be discontinued in this patient population. Aims Our goal is to determine whether TNF-α antagonist exposure in IBD is associated with a high risk NMSC presentation at diagnosis, as defined by the National Comprehensive Cancer Network (NCCN) stratification. Our secondary objectives include presence of positive margins following resection, presence of metastatic disease on initial presentation, requirement of additional therapy to treat NMSC, number of patients who had TNF-α antagonist therapy discontinued following diagnosis of NMSC and number of individuals with recurrent NMSC. Methods Four hundred and twenty-four IBD patients seen at London Health Sciences Centre were reviewed. We have identified 22 patients who were diagnosed with NMSC. Twelve patients had a pre-NMSC TNF-α antagonist exposure while 10 patients who developed an NMSC and had no TNF-α antagonist exposure prior to NMSC diagnosis. Results Preliminary results of the primary outcome demonstrate that fifty-percent (6/12) of patients who have been exposed to TNF antagonist therapy presented with a high risk NMSC lesion at diagnosis compared to 40% (4/10) who were not exposed (OR 5.16, 95%CI 0.47–57.00; p = 0.181). Preliminary results of the secondary outcomes suggest that 25% (3/12) of patients exposed to TNF-α antagonist had positive margins compared with 0% (0/10) of patients who were not exposed. No patients in either group presented with metastatic disease. Twenty-five percent (3/12) of patients in the exposed group received more advanced treatment compared with 0% (0/10) in the non-exposed group. Eight percent (1/12) of patients in the TNF-α antagonist group had their IBD therapy changed from a TNF-α antagonist to an alternative biologic class, and 17% of patients (2/12) in the TNF-α antagonist group had recurrent NMSC lesions. Conclusions In conclusion, preliminary results suggest that TNF-α antagonist exposure may be associated with higher risk NMSC lesion at presentation. Further expansion of the sample size is required to explore these hypotheses further. Funding Agencies None

BACKGROUND: Despite anti-rejection immunosuppressive therapies post-liver transplantation (LT), patients with concurrent inflammatory bowel disease (IBD) may have persistent bowel inflammation that requires addition of biologic therapy. AIMS: To evaluate the safety of combination biologic and anti-rejection therapy in IBD patients after LT. METHODS: The LT Registry at London Health Sciences Centre (LHSC) was searched to identify all patients undergoing LT from 1985–2018. IBD patients initiated on biologic treatment post-LT, in addition to anti-rejection therapy, were eligible for inclusion. Medical chart review was conducted to extract safety outcomes, including rates of infections, malignancy, colectomy and death. RESULTS: 19 patients were included (78.9% male, mean age 46.0 years, 8 patients with ulcerative colitis), followed for a median duration of 19 months (IQR 5.8, 30.8). Indications for LT included: primary sclerosing cholangitis (PSC) (14/19, 73.7%), autoimmune hepatitis (AIH) (2/19, 10.5%), AIH-PSC overlap syndrome (2/19, 10.5%), and biliary atresia (1/19, 5.3%). Post-LT, six patients were treated with only TNF antagonists (infliximab in 5 patients, golimumab in 1 patient); eight patients with only anti-integrin therapies (vedolizumab in 7 patients, natalizumab in 1 patient); and five patients with sequential TNF antagonists followed by either ustekinumab (n=2) or vedolizumab (n=3). Six patients required long-term prednisone. The most commonly used anti-rejection therapies were tacrolimus and mycophenolate mofetil. Disease course was complicated by infections in nine patients (47.4%), most commonly Clostridium difficile colitis (4/19, 31.6%). One patient had recurrent C. difficile infection and one patient had CMV colitis and viremia. Other infections included cholangitis (n=2), perianal abscess (n=1), JC virus seroconversion but without progressive multifocal leukoencephalopathy (n=1) and hospital-acquired pneumonia (n=1). Two patients required colectomy for refractory colitis. One patient required re-transplantation due to PSC recurrence. No deaths or malignancies were reported although one patient developed low grade colonic dysplasia. CONCLUSIONS: This is the largest reported case series from a single center to date evaluating the safety of combination biologic therapy with anti-rejection regimens in IBD patients post-LT. Whilst there appeared to be an increased risk of enteric infections, especially Clostridium difficile,there were no life-threatening infections reported. Active screening for enteric infections should be pursued in these patients presenting with increased IBD symptoms. FUNDING AGENCIES: None

BACKGROUND: Treatment targets in ulcerative colitis (UC) have evolved to include normalization of objective endoscopic and histologic endpoints. Minimizing the endoscopic and histologic placebo response and remission rate is critical for the conduct of efficient randomized controlled trials (RCTs) and development of new treatments, in order to maximize ability to detect differences between active comparator and placebo. AIMS: To quantify the endoscopic and histologic placebo response and remission rates in induction and maintenance UC RCTs and to identify trial design factors influencing these rates. METHODS: MEDLINE, EMBASE, and the Cochrane Library were searched from inception through March 1, 2017 for placebo-controlled RCTs of adult patients with UC treated with aminosalicylates, immunosuppressants, corticosteroids, biologics, and oral small molecules. Endoscopic and histologic placebo response and remission rates for induction and maintenance trials were pooled using a random-effects model. Patient- and trial-level covariates were evaluated by constructing stratum-specific rates of placebo response/remission and by random-effects meta-regression analysis. RESULTS: Placebo endoscopic response/remission rates were reported in 45 induction and eight maintenance trials; placebo histologic response/remission rates were reported in nine induction trials. Pooled estimates for placebo induction endoscopic remission, induction endoscopic response, and maintenance endoscopic remission rates were 25% [95 confidence interval (CI): 22–30%], 36% [29–43%], and 20% [16–24%], respectively. The pooled histologic remission rate in induction trials was 16% [10–25%]. Disease severity, disease duration, trial setting, trial phase, class of active comparator, trial follow-up duration, and endoscopic sub-score criterion for trial inclusion were not predictive of placebo endoscopic or histologic remission rates. CONCLUSIONS: Pooled placebo endoscopic and histologic response and remission rates vary according to whether trials are designed for induction or maintenance. Potential strategies to further reduce these rates include standardization of histologic scoring as well as the definitions used for response and remission. FUNDING AGENCIES: None

BACKGROUND: Trials of antibiotic therapy for Crohn’s disease (CD) have produced conflicting results. AIMS: We performed a systematic review and meta-analysis to determine the efficacy and safety of antibiotics for induction and maintenance of remission in CD. METHODS: EMBASE, MEDLINE, the Cochrane Library and the Cochrane IBD Group Specialized Register were searched from inception to September 2016. Randomized controlled trials (RCTs) comparing antibiotics to placebo or an active comparator in CD patients were considered for inclusion. Data were analyzed based on intention-to-treat. Risk ratios (RR) and corresponding 95% confidence interval (95% CI) were calculated for dichotomous outcomes. The primary outcome was the number of patients who failed to achieve clinical remission. Methodological quality was assessed using the Cochrane risk of bias tool. GRADE was used to assess the overall quality of the evidence for the primary outcome. RESULTS: Fourteen RCTs (n = 1469 patients) were eligible. Two trials were rated as high risk of bias (no blinding). Eight trials were rated as unclear risk of bias and 4 trials were rated as low risk of bias. Ciprofloxacin, metronidazole, clarithromycin, rifaximin and cotrimoxazole were evaluated at therapeutic doses. Comparisons included antibiotic vs. placebo, antibiotic vs. steroid, antibiotic vs. placebo in addition to usual therapy and antibiotic vs. placebo in addition to biologic therapy. A pooled analysis of 8 placebo-controlled RCTs (801 patients) showed no significant difference in clinical remission at 6 to 10 weeks. Fifty per cent (267/535) of antibiotic treated patients failed to enter remission compared to 59% (158/266) of placebo patients (RR 0.87, 95% CI 0.75–1.01; moderate quality evidence). A pooled analysis of two placebo-controlled studies (155 patients) showed no statistically significant difference in relapse rates at 52 weeks. Forty-five per cent (37/83) of antibiotic treated patients relapsed compared to 57% (41/72) of those assigned to placebo (RR 0.87, 95% CI 0.52–1.47; low quality evidence). There were no statistically significant differences between antibiotics and placebo in the proportion of patients with adverse events (RR 0.87, 95% CI 0.75–1.02; 9 studies; 852 patients), serious adverse events (RR 1.12, 95% CI 0.26–4.76; 4 studies; 555 patients), or withdrawal due to adverse events (RR 0.86, 95% CI 0.57–1.29; 9 studies; 858 patients). CONCLUSIONS: Antibiotics are ineffective for induction or maintenance of remission in Crohn’s disease. FUNDING AGENCIES: None