WITHDRAWN: EFFICACY, SAFETY, AND TOLERABILITY OF OMILANCOR IN A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF PATIENTS WITH ULCERATIVE COLITIS.

Background: Omilancor is an oral, once-daily, gut-restricted, small molecule, first-in-class therapeutic for Crohn's disease (CD) and ulcerative colitis (UC) that targets the novel LANCL2 pathway. Through LANCL2 activation, omilancor increases the suppressive capacity of regulatory immune cells, including regulatory CD4+ T cells (Tregs), locally within the intestinal mucosa. In a Phase I study in normal healthy volunteers no changes in AEs or trends in safety laboratory trends were observed up to daily oral doses of 7500 mg/day.

Fertility Impact of Initial Operation Type for Female Ulcerative Colitis Patients.

Background: Ileal pouch-anal anastomosis (IPAA) is the mainstay of surgical treatment for patients with ulcerative colitis (UC) but is associated with an increased risk of infertility. We developed a simulation model examining the impact of initial surgical procedure on quality-adjusted life-years (QALYs) and fertility end points.

Methods: A patient-level state transition model was used to analyze outcomes by surgical approach strategy for females of childbearing age.

Acute Venous Thromboembolism Risk Highest Within 60 Days After Discharge From the Hospital in Patients With Inflammatory Bowel Diseases.

Background & Aims: Patients with inflammatory bowel diseases (IBDs) have a high risk of venous thromboembolism (VTE). We assessed the timing and risk factors associated with readmission to the hospital for VTE among patients with IBD.

Methods: We collected data from the Nationwide Readmissions Database on IBD index admissions resulting in readmission to the hospital for VTE within 60 days, from 2010 through 2014.

Enteric Infections Are Common in Patients with Flares of Inflammatory Bowel Disease.

Objectives: Few studies have examined the role of non-Clostridium difficile enteric infections in flares of inflammatory bowel disease (IBD). Our objective was to investigate enteric infection detected by multiplex PCR stool testing in patients with IBD.

Methods: We performed a cross-sectional analysis of 9403 patients who underwent 13,231 stool tests with a gastrointestinal pathogen PCR panel during a diarrheal illness from March 2015 to May 2017.

Stool PCR for Gastrointestinal Pathogens in Patients With and Without Immune-Mediated Intestinal Diseases.

Background: Patients with celiac disease and inflammatory bowel disease, two immune-mediated luminal conditions, have higher rates of certain infections than healthy counterparts. The prevalence of many gastrointestinal infections in these patients, however, is unknown.

Aims: Using a novel clinical stool pathogen PCR test, we investigated the hypothesis that patients with celiac disease/inflammatory bowel disease had different distributions of diarrheal pathogens than other patients.

Enteric Infection in Relapse of Inflammatory Bowel Disease: The Utility of Stool Microbial PCR Testing.

Background: The similar presentations in relapse of inflammatory bowel disease (IBD) and enteric infection pose substantial barriers to diagnosis and treatment. The objective of this study was to investigate the incidence, etiology, predictors, and treatment of enteric infection in patients with IBD.

Methods: We reviewed the records of 214 patients with IBD who underwent 295 gastrointestinal pathogen panel and Clostridium difficile infection (CDI) polymerase chain reaction (PCR) stool tests during an exacerbation of symptoms.

Thiopurines and inflammatory bowel disease: Current evidence and a historical perspective.

The use of thiopurines in inflammatory bowel disease (IBD) has been examined in numerous prospective, controlled trials, with a majority demonstrating a clinical benefit. We conducted this review to describe the historical and current evidence in the use of thiopurines in IBD. A systematic search was performed on MEDLINE between 1965 and 2016 to identify studies on thiopurines in IBD.

Inflammatory bowel disease and cancer: The role of inflammation, immunosuppression, and cancer treatment.

In patients with inflammatory bowel disease (IBD), chronic inflammation is a major risk factor for the development of gastrointestinal malignancies. The pathogenesis of colitis-associated cancer is distinct from sporadic colorectal carcinoma and the critical molecular mechanisms underlying this process have yet to be elucidated. Patients with IBD have also been shown to be at increased risk of developing extra-intestinal malignancies.

Clostridium difficile Infection: A Rarity in Patients Receiving Chronic Antibiotic Treatment for Crohn's Disease.

Background: Prolonged antibiotic use is limited by several adverse effects, one of which is Clostridium difficile infection (CDI). The aim of this study was to determine the incidence of CDI in patients receiving chronic antibiotic treatment for Crohn's disease (CD).

Methods: We conducted a retrospective review of 100 patients with CD for which ≥6 months of outpatient antibiotic therapy was prescribed.

Human Placenta-derived Cells (PDA-001) for the Treatment of Moderate-to-severe Crohn's Disease: A Phase 1b/2a Study.

Background: PDA-001 (cenplacel-L), a preparation of placenta-derived mesenchymal-like adherent cells with immunomodulatory effects, previously demonstrated safety and tolerability in an open-label Crohn's disease (CD) study. The current phase 1b/2a study evaluated the safety and efficacy of PDA-001 in subjects with moderate-to-severe CD.

Methods: Subjects had active inflammation on colonoscopy or elevated fecal calprotectin and inadequate response to conventional therapy.

Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC.

Background & Aims: Mucosal healing might alter midterm and long-term outcomes of patients with Crohn's disease (CD) and has become an important end point in clinical trials. However, the minimal degree of mucosal improvement (endoscopic response) required to alter midterm outcomes is not known. We aimed to determine the best definition of endoscopic response by evaluating data on the Simple Endoscopic Score for Crohn's Disease (SES-CD) and the Crohn's Disease Endoscopic Index of Severity (CDEIS) from the Study of Biologic and Immunomodulator Naive Patients in Crohn's Disease (SONIC trial).

Risk of extraintestinal solid cancer with anti-TNF therapy in adults with inflammatory bowel disease: review of the literature.

With the increased use of anti-TNF therapy for both ulcerative colitis and Crohn's disease, there is serious concern about long term adverse events, especially malignancy. Recent data suggests that anti-TNF agents increase the risk of non-Hodgkin's lymphoma; however, there is limited evidence on the risk of solid tumors. Many patients have been exposed to other immunosuppressive therapies in the past making it difficult to discern the true risk of malignancy with TNF-alpha inhibitors alone.

Ustekinumab induction and maintenance therapy in refractory Crohn's disease.

Background: In patients with Crohn's disease, the efficacy of ustekinumab, a human monoclonal antibody against interleukin-12 and interleukin-23, is unknown.

Methods: We evaluated ustekinumab in adults with moderate-to-severe Crohn's disease that was resistant to anti-tumor necrosis factor (TNF) treatment. During induction, 526 patients were randomly assigned to receive intravenous ustekinumab (at a dose of 1, 3, or 6 mg per kilogram of body weight) or placebo at week 0.

The effect of intravenous cyclosporine on rates of colonic surgery in hospitalized patients with severe Crohn's colitis.

Background: The role of intravenous (IV) cyclosporine in severe Crohn's colitis (CC) is poorly studied.

Aim: Our primary aim was to determine the in-hospital colonic resection rate in patients with severe CC who received IV cyclosporine, and the potential predictors of resection among these patients.

Methods: An inpatient pharmacy query of all patients who received IV cyclosporine at Mount Sinai Medical Center for 12.

Infliximab, azathioprine, or combination therapy for Crohn's disease.

Background: The comparative efficacy and safety of infliximab and azathioprine therapy alone or in combination for Crohn's disease are unknown.

Methods: In this randomized, double-blind trial, we evaluated the efficacy of infliximab monotherapy, azathioprine monotherapy, and the two drugs combined in 508 adults with moderate-to-severe Crohn's disease who had not undergone previous immunosuppressive or biologic therapy. Patients were randomly assigned to receive an intravenous infusion of 5 mg of infliximab per kilogram of body weight at weeks 0, 2, and 6 and then every 8 weeks plus daily oral placebo capsules; 2.

Cyclosporine and infliximab as rescue therapy for each other in patients with steroid-refractory ulcerative colitis.

Background & Aims: In patients with severe corticosteroid-refractory ulcerative colitis, cyclosporine or infliximab may be added in an effort to induce remission. If the patient then fails either of these drugs, it is unknown whether success can be achieved by using the other agent. The aim of this study was to assess outcomes of using cyclosporine after failure of infliximab, and vice versa.

Adverse events associated with the use of cyclosporine in patients with inflammatory bowel disease.

Background: Intravenous cyclosporine (i.v. CsA) is an effective therapy for patients with inflammatory bowel disease (IBD).

Dilation of colonic strictures by intralesional injection of infliximab in patients with Crohn's colitis.

Background: Intestinal stenosis is a frequent complication of Crohn's disease, often leading to repeated bowel obstruction and surgery. The prevalence of small bowel stenosis has ranged from 20% to 40% and from 7% to 15% in patients with colonic disease. Although balloon dilation is the initial preferred approach, many patients eventually restenose and require surgical resection or stricturoplasty.

Mucosal dysplasia in ileal pelvic pouches after restorative proctocolectomy.

Purpose: Inflammation, villous atrophy, colonic metaplasia, and dysplasia have been observed within the mucosa of ileal pelvic pouches after restorative proctocolectomy. This study was designed to determine the prevalence of mucosal dysplasia in ileal pouch and any associated risk factors.

Methods: Prospectively registered patients having restorative proctocolectomy were recruited.