The Digestive Disease Week annual meeting sponsored by the American Association for the Study of Liver Diseases, American Gastroenterological Association, American Society for Gastrointestinal Endoscopy, and Society for Surgery of the Alimentary Tract was held from June 2 to 5 in Washington, D.C., and attracted approximately 16,000 participants from around the world, including researchers and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery.
In a phase 2A, placebo-controlled, randomized, prospective study, Markku Maki, M.D., Ph.D., of the University of Tampere in Finland, and colleagues found that an investigational new drug, AMG 714, offered relief for celiac disease patients who were inadvertently exposed to gluten while on a gluten-free diet.
“A gluten-free diet has been the only treatment option available for celiac disease patients. However, gluten contamination can happen during food processing or packaging, during cooking, or due to inadequate labeling,” Maki said. “Toothpaste, lipstick, and even medicines contain gluten; it is virtually impossible to avoid gluten completely and permanently. This leads to many celiac patients being inadvertently exposed to gluten, which can trigger gastrointestinal symptoms, such as gut pain and diarrhea, as well as a range of other complications.”
The investigators compared the effects of AMG 714 at 150 mg and 300 mg to a placebo among celiac disease patients over a 12-week period. The drug was administered six times by subcutaneous injection. The investigators found that the AMG 714 antibody, which blocks interleukin 15, an important mediator of celiac disease, led to fewer symptoms and less gut inflammation following gluten exposure.
“While the primary end point (mucosal histology improvement) was not met, AMG 714 was found to reduce the gluten-triggered effects (symptoms and inflammation) in patients receiving AMG 714, compared to placebo. The safety profile was acceptable, with no serious adverse events reported,” Maki said. ” It’s important to note that AMG 714 is intended to protect against modest contamination of gluten and not against the effects of deliberately eating large amounts, like bread or pasta. However, because we know people with celiac disease are inadvertently exposed to gluten even while on a gluten-free diet, it is our hope that AMG 714 will allow these patients to experience fewer gluten-triggered events.”
In a phase III study, Alessandro Repici, M.D., of Istituto Clinico Humanitas in Milan, and colleagues found that the use of a special formulation to deliver methylene blue in the colon, Methylene Blue MMX, provided a nice staining effect of chromoendoscopy at the time of colonoscopy.
“This is unique since we know from previous randomized studies that conventional chromoendoscopy is effective in increasing adenoma detection rate but has not been adopted in clinical practice because it is labor intensive and time consuming,” Repici said.
The study, involving 18 different centers across Europe and the United States randomized 1,205 patients to be scoped with standard of care (high-definition white light colonoscopy) or colonoscopy having taken eight tablets of methylene blue for an overall dosage of 200 mg.
“The group of patients randomized to receive Methylene Blue MMX the day before colonoscopy had a significantly higher adenoma detection rate compared to controls,” Repici said. “This increase in the adenoma detection rate was confirmed when data was broken down according to polyp morphology, size, and location, thus confirming that Methylene Blue MMX has a powerful incremental diagnostic effect in the field of colonoscopy. Remarkably, no serious adverse events have been reported in the study.”
Saroja Bangaru, M.D., of the University of Texas Southwestern Medical Center in Dallas, and colleagues found that liver transplantation is becoming an acceptable treatment modality in carefully selected patients with severe alcoholic hepatitis (SAH).
“Historically, there has been a reluctance to transplant patients presenting with SAH, and a minimum abstinence period of six months was required. However, following recent publications showing that patients with SAH who are transplanted have excellent outcomes, U.S. transplant centers are now increasingly considering these patients for liver transplantation with excellent outcomes. This represents a paradigm shift in how these patients are managed from only a decade ago,” Bangaru said. “It is important to note that the vast majority of centers that consider these patients for liver transplant have strict criteria patients have to fulfill before they receive a liver transplant. Although these patients have excellent outcomes, as a transplant community, we need to do better to provide post-transplant care and counseling for these patients.”
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