The influence of anti-TNF therapy on the course of chronic hepatitis C virus infection in patients with inflammatory bowel disease.

Background: The immunosuppressive potential of anti-tumor necrosis factor (TNF) in exacerbating chronic hepatitis C virus (HCV) infection has been a major concern. We aim to critically analyze the impact of anti-TNF on the course of chronic HCV infection in patients with concurrent inflammatory bowel disease (IBD) and HCV infection.

Materials And Methods: Patients with diagnosis of IBD and HCV were identified retrospectively through the University of Pennsylvania Health System electronic database.

Risk of Biologic Therapy-Associated Progressive Multifocal Leukoencephalopathy: Use of the JC Virus Antibody Assay in the Treatment of Moderate-to-Severe Crohn's Disease.

For treatment of moderate-to-severe active Crohn's disease, clinicians generally rely on immunosuppressants (including azathioprine and 6-mercaptopurine), corticosteroids, and antibodies against tumor necrosis factor α. However, a significant proportion of patients do not respond to these therapies, lose response over time, or are intolerant to these therapies. In such cases, one of the only remaining pharmacologic treatment options is natalizumab, an α4 integrin-targeted antibody.

Serious infection and mortality in patients with Crohn's disease: more than 5 years of follow-up in the TREAT™ registry.

Objectives: The objective of this study was to contribute long-term safety data for infliximab and other therapies in Crohn's disease (CD).

Methods: We prospectively evaluated CD patients enrolled in the large, observational Crohn's Therapy, Resource, Evaluation, and Assessment Tool registry, established to compare infliximab safety with conventional nonbiological medications in CD.

Results: A total of 6,273 patients were enrolled and evaluated on or before 23 February 2010; 3,420 received infliximab (17,712 patient-years; 89.

Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations: a pooled analysis from two randomised controlled trials.

Background: Mesalazine (mesalamine) granules (MG) were shown to be effective for the maintenance of remission of ulcerative colitis (UC) in two double-blind placebo-controlled trials.

Aim: To evaluate the efficacy of once-daily MG for maintenance of remission in patients with UC who switched from other 5-aminosalicylic acid (5-ASA) formulations.

Methods: Data from two independent multicenter, randomised, double-blind, placebo-controlled, 6-month trials evaluating patients with UC in remission were combined for analysis of a subpopulation of patients who switched from other 5-ASA formulations to MG 1.

A pooled analysis of infections, malignancy, and mortality in infliximab- and immunomodulator-treated adult patients with inflammatory bowel disease.

Objectives: The objective of this study was to analyze the safety of long-term infliximab treatment, with/without concomitant immunomodulators, across Crohn's disease (CD) and ulcerative colitis (UC) clinical trials.

Methods: To maximize sample size, we pooled primary safety data across 10 CD or UC trials, including five randomized, controlled trials contributing data from patients who received intravenous infliximab 5 or 10 mg/kg (n=1,713; ±azathioprine) or placebo (n=406; ±azathioprine). Pooled incidences and 95% confidence intervals (CIs) were determined for mortality, infection, and malignancy.

Clinical predictors of aggressive/disabling disease: ulcerative colitis and crohn disease.

Many clinical factors predict the aggressive course of CD. Younger age at initial diagnosis, the presence of perianal lesions, ileal involvement, smoking, and the need for therapy with corticosteroids are the major predictors of disabling disease or change of behavior to a more aggressive disease. On the other hand, treatment with azathioprine and biologic agents and colonic localization of disease are the major factors that are predictive of less aggressive CD course.

Patient adherence and efficacy of certolizumab pegol in the management of Crohn's disease.

Treatment with Anti-Tumor Necrosis Factor (anti-TNF) therapy has become a mainstay of therapy for patients with CD who are unresponsive to conventional medical management. Currently there are three anti-TNFα antibodies that have been approved by the US Food and Drug Administration for the treatment of CD, namely infliximab, adalimumab and certolizumab pegol (CZP). Several double blind placebo controlled trials determined that CZP is effective as induction and maintenance treatment in adult patients with CD regardless of their prior exposure to other anti-TNFα antibodies.

Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS).

Background: Variability in endoscopic assessment necessitates rigorous investigation of descriptors for scoring severity of ulcerative colitis (UC).

Objective: To evaluate variation in the overall endoscopic assessment of severity, the intra- and interindividual variation of descriptive terms and to create an Ulcerative Colitis Endoscopic Index of Severity which could be validated.

Design: A two-phase study used a library of 670 video sigmoidoscopies from patients with Mayo Clinic scores 0-11, supplemented by 10 videos from five people without UC and five hospitalised patients with acute severe UC.

Early symptomatic response and mucosal healing with mesalazine rectal suspension therapy in active distal ulcerative colitis--additional results from two controlled studies.

Background: Rapid resolution of symptoms and endoscopic inflammation in ulcerative colitis (UC) represent important treatment goals.

Aims: To establish times to bleeding cessation and endoscopic healing for topical and oral mesalazine in active distal UC, a post hoc analysis of two published studies was performed.

Methods: Study I (Sutherland 1987) compared mesalazine rectal suspension to placebo, while Study II (Safdi 1997) compared topical suspensions, either alone or in combination with oral mesalazine, and oral alone.

The London position statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn's and Colitis Organisation: safety.

This paper in the series from the World Congress of Gastroenterology addresses the safety and immunogenicity of biological therapy. The safety profile in randomized controlled studies of all biological agents in Crohn's disease (CD) and ulcerative colitis has been generally favorable, but a small percentage of patients experience severe side effects on biological therapy, including pneumonia, tuberculosis, lymphoma, demyelination, drug-induced lupus, or hepatotoxicity. Although there is unequivocal evidence of an increased risk of serious infection among patients with rheumatoid arthritis treated with anti-tumor necrosis factor therapy, the evidence is less clear in CD.

Update on the management of Crohn's disease.

Crohn's disease (CD) is a chronic inflammatory disorder characterized by focal, asymmetric, transmural inflammation of any part of the luminal gastrointestinal tract of uncertain etiology and an unpredictable course. The available treatment options include aminosalicylates, budesonide and systemic corticosteroids, antibiotics, immunomodulators,methotrexate and anti-TNF agents. This review discusses recent developments in the treatment of CD and provides a comprehensive update on management of patients with CD based on the data from randomized controlled trials.

No increased risk of myocardial infarction among patients with ulcerative colitis or Crohn's disease.

Background & Aims: Patients with chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus, and psoriasis have an increased risk of myocardial infarction (MI). Studies of the risk of MI among patients with inflammatory bowel disease have provided inconsistent results. We aimed to determine the risk of first-time acute MI in patients with ulcerative colitis (UC) or Crohn's disease (CD) compared with patients from general practice.

Early mucosal healing with infliximab is associated with improved long-term clinical outcomes in ulcerative colitis.

Background & Aims: In the Active Ulcerative Colitis Trial (ACT)-1 and ACT-2, patients with ulcerative colitis treated with infliximab were more likely than those given placebo to have a clinical response, undergo remission, and have mucosal healing. We investigated the association between early improvement (based on endoscopy) and subsequent clinical outcome.

Methods: Patients underwent endoscopic evaluations at weeks 0, 8, 30, and 54 (ACT-1 only), and were categorized into 4 subgroups by week 8 (Mayo endoscopy subscore, 0-3).

Inflammatory bowel disease therapy: current state-of-the-art.

Purpose Of Review: The aim of this article is to review current evidence-based approaches to treatment of ulcerative colitis and Crohn's disease.

Recent Findings: The primary goal of treatment is to induce and to maintain remission in a safe and efficacious fashion. The 5-aminosalicylic acid (5-ASA) agents and oral steroids remain the first-line approach for the treatment of ulcerative colitis and Crohn's disease.

Long-term infliximab maintenance therapy for ulcerative colitis: the ACT-1 and -2 extension studies.

Background: The aim was to evaluate long-term efficacy, quality of life, and safety in ulcerative colitis patients who received infliximab during the ACT-1 and -2 extension studies.

Methods: Adults with moderate-to-severely active ulcerative colitis in the 54-week ACT-1 and 30-week ACT-2 studies who achieved benefit from infliximab were eligible to participate in extension studies and receive up to 3 additional years of therapy. Patients received randomized study medication until all sites were unblinded; placebo-treated patients were discontinued.

Combination of genetic and quantitative serological immune markers are associated with complicated Crohn's disease behavior.

Background: Treatment of Crohn's disease (CD) with biologics may alter disease progression, leading to fewer disease-related complications, but cost and adverse event profiles often limit their effective use. Tools identifying patients at high risk of complications, who would benefit the most from biologics, would be valuable. Previous studies suggest that biomarkers may aid in determining the course of CD.