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BACKGROUND AND GOALS: Despite published clinical guidelines, substantive data underlying the approach to the management of hospitalized ulcerative colitis (UC) patients failing outpatient therapy are lacking. Variability in practice is therefore not uncommon and may impact clinical outcomes. The degree of variability, however, is not well-studied. Our aim was to evaluate variability in management of the hospitalized UC patient to inform future efforts targeting care optimization for this high-risk population. STUDY: An internet survey was distributed among inflammatory bowel disease providers, which included: (1) nonvignette-based questions assessing provider demographics, experience, and practice setting; (2) diagnostic and therapeutic practice patterns based on a vignette of a hospitalized UC patient. Descriptive and univariate analyses were performed. RESULTS: Ninety-one percent of eligible individuals were included. Nearly 97% endorsed confidence in management of hospitalized UC patients. In general, 83% initiate intravenous corticosteroids (IVCS) as initial therapy, whereas 17% initiate infliximab (IFX) (+ / −IVCS). At IVCS failure in the vignette, 74% initiated IFX, 15% increased IVCS dose, 7% initiated cyclosporine, and 4% chose colectomy. Of those choosing IFX, 65% chose 5 mg/kg as the initial dose, whereas the remainder chose 10 mg/kg. Twenty-eight percent gave an additional IFX 5 mg/kg and 7% gave an additional 10 mg/kg dose to the patient in the vignette not responding to 5 mg/kg. CONCLUSIONS: Even among experienced inflammatory bowel disease providers, there is significant practice pattern variability in the management of hospitalized UC patients. Future efforts should target this variability. Adjunctively, prospective trials are needed to guide appropriate therapeutic algorithms, especially with respect to positioning and optimally dosing IFX in this population.

Crohn's disease is an idiopathic inflammatory disorder of unknown etiology with genetic, immunologic, and environmental influences. The incidence of Crohn's disease has steadily increased over the past several decades. The diagnosis and treatment of patients with Crohn's disease has evolved since th

Cigarette smoking is one of the most important, modifiable environmental factors in Crohn's disease (CD) and screening for tobacco use is an official recommendation and quality measure in the care of CD patients. The objective of this study was to learn more about gastroenterologists' practices, opinions, and knowledge in this area.A 15 question survey was sent through email to two national gastroenterology distribution lists. Questions were written in multiple choice formats and were designed to collect information about gastroenterologists' practices, attitudes, and knowledge regarding smoking cessation in CD patients. Responses were stratified by practice setting, experience, and inflammatory bowel disease-focus. Responses were anonymous and were collected in a secure, online database.A total of 141 respondents completed the survey. Overall, 89% of participants screened their CD patients for smoking more than 75% of the time. In all, 62% provided smoking cessation counseling more than 75% of the time. Overall, 94% of respondents felt comfortable discussing the benefits of smoking cessation with their patients. In all, 56% felt comfortable discussing smoking cessation strategies with their patients. Overall, 88% of respondents agreed that gastroenterologists should provide smoking cessation counseling; however, 43 and 11% agreed that the gastroenterologist should be the primary counselor and primary prescriber of cessation-related pharmacotherapy, respectively.Surveyed gastroenterologists agree that smoking cessation is an important part of the care of CD patients and this is reflected in their screening practices. Counseling occurs irregularly and many gastroenterologists do not feel comfortable discussing cessation strategies. Future guidelines should provide further guidance on the gastroenterologist's role in smoking cessation counseling for CD patients.

Introduction: Drug survival in open-label, long-term extension (OLE) studies may provide information on the long-term efficacy and tolerability of a therapy. Methods: We present data on the persistence of tofacitinib treatment in the OLE study for: (1) delayed responders: induction non-responders (pts who did not achieve a clinical response [CR] after 8 weeks [wks] induction treatment with tofacitinib 10 mg BID) who achieved a CR at Wk 8 (total of 16 wks induction) of the OLE study and continued to receive 10 mg BID;(2) retreatment responders: tofacitinib 10 mg BID induction responders who experienced treatment failure with PBO in OCTAVE Sustain and entered the OLE study and received 10 mg BID, and achieved a CR at Wk 8 of the OLE study;and (3) dose escalation responders: tofacitinib 10 mg BID induction responders who experienced treatment failure with 5 mg BID in OCTAVE Sustain and entered the OLE study and received 10 mg BID, and achieved a CR at Wk 8 of the OLE study (Figure 1). The calculations are based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there are no missing data due to COVID-19. 3CDAI 50% from baseline (or for subjects with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline), as scored by central readers.

The introduction of anti-tumor necrosis factor (anti-TNF) therapies for both Crohn’s disease (CD) and ulcerative colitis (UC) was a landmark in the management of these debilitating diseases. For a substantial proportion of patients, anti-TNF therapies have reduced relapse rates and allowed mucosal healing and, as a result, improved long-term outcomes. However, research into novel therapies for inflammatory bowel diseases (IBD) has been challenging and positive early trials have not always translated to proof of efficacy and safety in late-phase studies. As an alternative to targeting inflammation through cytokines (e.g., TNF), reducing the ability of lymphocytes to generate an inflammatory response is now a therapeutic reality with the availability of the integrin inhibitors. The “gut-selective” vedolizumab is now an established treatment option for UC and CD either before, or after, anti-TNF therapy. Other agents in development that target lymphocyte adhesion include novel anti-integrin and anti-mucosal vascular addressin cell adhesion molecule-1 (anti-MadCAM-1) agents, or target lymphocyte trafficking (e.g. anti-sphingosine 1-phosphate therapies). In addition however, there are novel ways of reducing inflammation by targeting downstream signaling (e.g., Janus kinase inhibitors), the use of antisense oligonucleotides to transforming growth factor-β, or by targeting novel cytokines such as interleukin-12/23 or interleukin-6 that have been implicated in the pathogenesis of IBD. The introduction of a novel formulation of budesonide (budesonide MMX) for UC illustrates that for patients with mild IBD there is also a need for novel therapies and agents in development, include other second-generation corticosteroids that are associated with reduced systemic delivery and approaches to enhance the mucosal barrier or alter the microbiota. Many new and effective therapies are in development for IBD and, if positive in late phase trials, are anticipated to be available within the next decade. Having a number of different agents available will allow the clinician to offer the best therapies for an individual patient. This will likely have huge implications not only for patients and clinicians, but for society as a whole.

We assessed the real-world effectiveness and safety of vedolizumab (VDZ) in moderate-severe Crohn's disease (CD).Retrospective cohort study of seven medical centers, from May 2014 to December 2015. Adults with moderate-severe CD treated with VDZ, with follow-up after initiation of therapy, were included. Using the multivariable Cox proportional hazard analyses, we identified independent predictors of clinical remission or mucosal healing with VDZ. Rates of serious infection (requiring antibiotics, resulting in discontinuation of VDZ, hospitalization or death) and serious adverse events (discontinuation of VDZ, hospitalization or death) were described quantitatively.We included 212 patients with moderate-severe CD (median age 34 years; 40% male; 90% tumor necrosis factor (TNF)-antagonist exposed) with a median follow-up (IQR) of 39 weeks (25-53). Twelve-month cumulative rates of clinical remission, mucosal healing, and deep remission (clinical remission+mucosal healing) were 35%, 63%, and 26%, respectively. Individuals with prior TNF-antagonist exposure (hazard ratio (HR) 0.40; 95% confidence interval (CI): 0.20-0.81), smoking history (HR 0.47; 95% CI: 0.25-0.89), active perianal disease (HR 0.49; 95% CI: 0.27-0.88), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve clinical remission. Those with prior TNF-antagonist exposure (HR 0.29; 95% CI: 0.12-0.73), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve mucosal healing. During 160 patient years of follow-up (PYF) and 1,433 VDZ infusions, 5 patients developed infusion reactions (3.5 per 1,000 infusions), 21 developed serious infections (13 per 100 PYF), and 17 developed serious adverse events (10 per 100 PYF). A minority of adverse events required discontinuation of therapy (6 per 100 PYF).VDZ is a safe and effective treatment option for moderate-severe CD in routine practice. Clinical remission and deep remission (clinical remission and mucosal healing) can be achieved in 1/3 of individuals, and a minority of individuals require discontinuation of therapy due to adverse events.