Estimation of the Harvey Bradshaw Index from the Patient-Reported Outcome 2 in Crohn's Disease: Results Based on a Large Scale Randomized Controlled Trial.

Background: Many registrational trials in Crohn's disease assess treatment efficacy with the 2-item Patient-Reported Outcome (PRO2), while the Harvey-Bradshaw Index (HBI) is prominent in pragmatic trials and clinical practice. The translation between PRO2 and HBI has not been established.

Methods: Data from a Phase 3 trial of vedolizumab in Crohn's disease were used to determine the Pearson correlation between PRO2 and HBI.

The Clinical Interpretation of Cluster Trials.

Cluster-randomized trials randomize entire groups of participants, instead of individual participants, to different treatment arms. For certain interventions (eg, institutional policies, processes of care, treatment algorithms), these designs protect against contamination between study arms. However, cluster trials are logistically complex to implement and have unique vulnerabilities that must be evaluated for accurate interpretation.

Cannabis Use in Patients With Inflammatory Bowel Disease Following Legalization of Cannabis in Canada.

Background: Cannabis is used by patients with Crohn's disease (CD) and ulcerative colitis (UC) as an alternative to, or in combination with, conventional therapies to treat symptoms such as abdominal pain, poor sleep, and reduced appetite. The clinical efficacy of cannabis for these disorders is controversial, with some studies showing harmful outcomes associated with its use. Previous studies suggest that cannabis is used by ~12% of patients with UC and ~16% of patients with CD in the USA despite legal prohibition.

Reliability and Responsiveness of Clinical and Endoscopic Outcome Measures in Crohn's Disease.

Background: Regulatory guidance for Crohn's disease trials recommends coprimary efficacy end points that evaluate both symptoms and mucosal inflammation. We aimed to characterize the operating properties of commonly used disease activity assessments alone and in combination.

Methods: Endoscopic and clinical data were available for 129 participants from the Study of Biologic and Immunomodulator Naïve Patients in Crohn's Disease trial.

The Clinical Interpretation of Noninferiority Trials.

Noninferiority trials are designed to demonstrate that a new treatment is not unacceptably worse than a standard treatment, considering an allowable difference termed the noninferiority margin. We highlight that selection of noninferiority margins at the time of study design can be biased toward wider margins that favor noninferiority claims. We discuss a clinically oriented approach to interpretation of results with a focus on confidence intervals and recommend that readers base their judgments regarding noninferiority on margins reflecting patient values and preferences rather than those set by investigators.

Standardizing Scoring Conventions for Crohn's Disease Endoscopy: An International RAND/UCLA Appropriateness Study.

Background And Aims: Endoscopic assessment of disease activity is integral for evaluating treatment response in patients with Crohn's disease (CD). We aimed to define appropriate items for evaluating endoscopic activity and conventions for consistent endoscopic scoring rules in CD.

Methods: A 2-round modified RAND/University of California at Los Angeles Appropriateness Method study was conducted.

Increased Hospitalization for IBD Patients Seen in the ER During the COVID-19 Pandemic.

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.

Short-Term COVID-19 Pandemic-Related Endoscopy Delays Did Not Translate to Deleterious Outcomes for Patients With Inflammatory Bowel Disease: A Retrospective Cohort Study.

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).

Examination Under Anesthesia May Not Be Universally Required Prior to Anti-TNF Therapy in Perianal Crohn's Disease: A Comparative Cohort Study.

Background: Multidisciplinary care involving exam under anesthesia (EUA) and tumor necrosis factor (TNF) inhibitors is recommended for perianal Crohn's disease. However, the impact of this combined approach is not well established.

Methods: We performed a comparative cohort study between 2009 and 2019.

Review article: paradoxical psoriasis as a consequence of tumour necrosis factor antagonists in patients with inflammatory bowel disease.

Background: Tumour necrosis factor (TNF) antagonists are an efficacious therapy used in the management of several immune-mediated inflammatory diseases, including inflammatory bowel disease (IBD) and psoriasis. However, since being prescribed more widely, reports of new-onset psoriatic lesions have began to emerge in the literature and are known as paradoxical psoriasis.

Aim: To review the evidence available in both the dermatology and gastroenterology literature pertaining to the entity known as paradoxical psoriasis as it relates to IBD and to create a comprehensive guide to assist clinicians who treat this challenging patient population.

Etrolizumab for maintenance therapy in patients with moderately to severely active ulcerative colitis (LAUREL): a randomised, placebo-controlled, double-blind, phase 3 study.

Background: Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In a previous phase 2 induction study, etrolizumab significantly improved clinical remission versus placebo in patients with moderately to severely active ulcerative colitis. We aimed to evaluate the efficacy and safety of etrolizumab for maintenance of remission in patients with moderately to severely active ulcerative colitis.

Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn's Disease.

Background: The lack of standardized methods for clinical trial design and disease activity assessment has contributed to an absence of approved medical therapies for the prevention of postoperative Crohn's disease (CD). We developed recommendations for regulatory trial design for this indication and for endoscopic assessment of postoperative CD activity.

Methods: An international panel of 19 gastroenterologists was assembled.

Crohn's and Colitis Canada's 2021 Impact of COVID-19 and Inflammatory Bowel Disease in Canada: Epidemiology-The Trends of Disease Over Time.

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 ( ) and the countervailing forces that exert upward or downward pressure on the spread of the virus at a given point in time.

Crohn's and Colitis Canada's 2021 Impact of COVID-19 & Inflammatory Bowel Disease in Canada: A Knowledge Translation Strategy.

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.

Crohn's and Colitis Canada's 2021 Impact of COVID-19 and Inflammatory Bowel Disease in Canada: Executive Summary.

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.