For people with celiac disease, sticking to the gluten-free diet can be a challenging, if vital, treatment. Gluten was first identified in the 1950s as the trigger for celiac disease. Since then, the gluten-free diet has been the gold standard of treatment. But health practitioners and patients alike have concerns about the efficacy of the gluten-free diet to adequately control celiac disease in both children and adults.
A growing body of evidence shows that there is a substantial subgroup of celiac patients who do not respond well to the diet. Their intestinal inflammation, which creates malabsorption of nutrients leading to an array of symptoms, does not resolve even after strict adherence to the diet. And for many patients, cross-contamination while traveling or dining away from home is a real threat to eating safely in outside environments.
These concerns and a push for alternative treatments culminated in a milestone meeting sponsored by the U.S. Food and Drug Administration on March 31, 2015, in Silver Spring, Md. Looking for different treatment options for this hard-to-treat group of patients, along with other topics, was the focus of the Gastroenterology and Regulatory Endpoints and the Advancement of Therapeutics (GREAT3) Workshop. It brought together international experts, including clinicians, academics, and industry and patient representatives, to discuss best clinical outcomes and therapeutic treatments for patients with celiac disease and other gluten-related disorders during the daylong workshop.
“We are really pushing forward the agenda to develop advanced therapeutics for people of all ages with celiac disease and gluten-related disorders.”
A Celiac Community Milestone
Alessio Fasano, MD, director of the Center for Celiac Research and Treatment at MassGeneral Hospital for Children, presented an overview of pediatric patients with celiac disease and identified target populations for pharmacological interventions at GREAT3. “We had a very productive discussion with representatives of the FDA, industry representatives and members of the celiac community,” says Dr. Fasano.
“We are really pushing forward the agenda to develop advanced therapeutics for people of all ages with celiac disease and gluten-related disorders,” says Dr. Fasano. “This recognition is a terrific milestone for the celiac community, as well as a step toward alternative treatments to the gluten-free diet—one of the early goals of our Center.”
Striving to Stay Safe
The Center has made great strides to improve the quality of life for people with celiac disease and other gluten-related disorders. Founded in 1996 by Dr. Fasano, many of the innovations and discoveries from the Center have led to increased awareness, improved diagnosis and greater understanding of the molecular mechanisms of celiac disease and non-celiac gluten sensitivity. In 2004, Dr. Fasano’s earlier discovery of zonulin, which regulates intestinal permeability, led to the formation of Alba Therapeutics Corporation, the first biopharmaceutical company working on alternative treatments to the gluten-free diet.
“The celiac disease community tells us often and unequivocally how hard it is for them to stay safe when trying to stay gluten-free.”
National Foundation for Celiac Awareness President and CEO Alice Bast brought the patient perspective to the discussion as a panel participant. “The celiac disease community tells us often and unequivocally how hard it is for them to stay safe when trying to stay gluten-free,” says Bast.
The GREAT3 workshop, which also included a separate daylong discussion on therapeutic endpoints for irritable bowel disorder, was co-sponsored by the American College of Gastroenterology; the American Gastroenterological Association; the Crohn’s and Colitis Foundation of America, Inc.; the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition; the North American Society for the Study of Celiac Disease; and the Pediatric IBD Foundation.
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