ACG 2010 Morning President's Plenary Session

Chris Cole

Results from five standout studies were presented during this morning's President's Plenary Session.

Results from five standout studies were presented during this morning’s President’s Plenary Session.

A Randomized Placebo-controlled Trial of Swallowed Fluticasone as Treatment of Eosinophilic EsophagitisA team of researchers from the Mayo Clinic, both in Rochester, MN, and Jacksonville, FL, presented the results of this study, which looked at aerosolized swallowed fluticasone in adults with eosinophilic esophagitis (EoE), as only one placebo-controlled trial has looked at a topical steroid therapy of EoE, and it looked at the agent in children. For the study, 19 of 34 patients who completed the protocol received fluticasone 880mcg twice daily for 6 weeks, with 24-hour urine cortisol, endoscopy, and biopsy results monitored at 6 weeks after treatment.

Based on intention to treat (ITT) and per protocol (PP) analysis, significant histologic responses were seen in 71% and 79%, respectively, of patients who received fluticasone, compared with 10% and 13%, respectively, of those who received placebo. Symptoms response was similar between the groups—with ITT analysis showing 71% in the fluticasone group and 48% in the placebo group and PP analysis showing 68% and 74%, respectively—as was the frequency of abnormal endoscopic findings (79% before fluticasone and 68% after, compared with 80% before placebo and 88% after).

With these findings, the Mayo Clinic team concluded that “aerosolized swallowed fluticasone is associated with histologic but not symptomatic nor endoscopic improvement of EoE in patients who failed to initially respond to PPI therapy. The lack of symptomatic and endoscopic improvement may be the result of EoE lesions that are not immediately steroid responsive.”

Hepatitis B Virus Immunity in Pediatric Patients on Biologics for Inflammatory Bowel Disease: Results of a Prospective Cross-sectional StudyBecause a session with representatives from just one of the top clinics in medicine wouldn’t be impressive enough, the plenary session included this presentation from a team of healthcare professionals at the Cleveland Clinic. Their study was conducted to “determine hepatitis B immunity and prior exposure in children with IBD on infliximab therapy for IBD.” The study included 100 pediatric patients with a mean age of 17.8 years, those of whom with an anti-HBs level ≥10 mIU/mL were considered to be immune.

In the cohort of pediatric patients with IBD, just half had protective anti-HBs levels. “Patients with IBD treated with infliximab without protective immune status against HBV are potentially at risk for severe liver disease if exposed to the virus in the community or if the virus is reactivated in chronic carries,” concluded the team, adding that “checking HBV immunity in children with IBD should be strongly considered when patients are started on therapy with infliximab.”

Safety and Outcome of Endoscopic Therapy for Ileal Pouch StricturesAnother team of researchers from the Cleveland Clinic conducted this study, which sought to “evaluate endoscopic balloon dilation and needle knife therapy of pouch strictures with pouch patients with or without Crohn’s disease (CD),” as endoscopic management of ileal pouch strictures had yet to be systemically studied. Of 150 patients studied, 10 had acute puchitis, 26 chronic pouchitis, 62 CD of the pouch, 12 cuffitis, and 40 surgery-associated strictures. Thus, a cumulative 646 strictures were endoscopically dilated, with a total of 406 pouchoscopies using the gastroscope.

A technical success rate of 100% was seen, as measured by the passage of the gastroscope after dilation. Just two perforations and four transfusion-required bleedings occurred during 406 therapeutic endoscopies. After a median follow-up 9.6 years, 19 patients developed pouch failure. The researchers concluded that endoscopic “treatment of pouch stricture is safe and efficacious, by improving pouch survival. Underlying diagnosis of CD of the pouch and surgery-related strictures, multiple strictures are the risk factors for pouch failure.”

Comparison of Lactase Variant MCM6-13910C>T Testing and Self-Report of Dairy Sensitivity in Patients with Irritable Bowel SyndromeThe Mayo Clinic was represented again with the presentation of this study, from a team in the department of gastroenterology and hepatology in Rochester, MN. The study was designed to evaluate “the agreement of MCM6 -13910C>T genotype with patient self-report of dairy sensitivity (DS),” as agreement “between medically documented lactase deficiency and self-reported lactose intolerance is poor,” patients with IBS—60% of whom report sensitivity of dairy products—may present with similar symptoms, and the “single nucleotide polymorphism (SNP), -13910C>T (rs4988235), on the MCM6 gene (upstream from the LCT lactase gene) has been reported to be 100% associated with adult lactase non-persistence in European Caucasians.”

The case-control study looked at 645 patients with IBS and 323 controls with a median age of 50 years, all of whom were asked to complete a self-report Bowel Disease Questionnaire and a self-report of DS. Of those with IBS, 262 reported DS, compared to 32 controls. “Agreement between genotype and DS was 80% in controls and 55% in cases, with the number of cases reporting DS but being LP (n=218) far exceeding those with LNP (n=44).” With these findings, the team concluded that although patients with IBS report DS frequently, self-report of DS is a poor indicator of a true underlying LNP genotype.

Early Resuscitation with Lactated Ringer’s Reduces Systemic Inflammation in Acute Pancreatitis: A Multi-Center Randomized-Controlled TrialThis study, which received the 2010 ACG Governors Award for Excellence in Clinical Research, was presented by a team of investigators from Brigham and Women’s Hospital in Boston and Dartmouth-Hitchcock Medical Center in Lebanon, NH. Their study was conducted to “evaluate the impact of a goal-directed fluid resuscitation protocol vs. standard resuscitation on systemic inflammation” and the “impact of resuscitation with Lactated Ringer’s (LR) versus normal saline (NS) on systemic inflammation during the initial 24 hours of hospitalization.”

At 24 hours, reduction in systemic inflammation was not achieved with goal-directed fluid resuscitation compared to standard resuscitation, with the volume of administered fluid during the initial 24 hours similar between standard and goal-directed. However, reduced systemic inflammation was seen at 24 hours in those patients who were resuscitated with Lactate Ringer’s, compared with those who received normal saline.