Celiac.com 10/09/2015 - For each the past three years, the FDA has sponsored a public workshop focusing on end points and clinical outcomes for drug development in GI diseases. The program is known as the Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics, or by the acronym: GREAT.
This year, GREAT 3, celiac disease was the focus. Experts addressed topics that included difficulties in assembling an appropriate target population for pharmacologic therapy, defining and measuring efficacy in clinical celiac disease trials, and the timing of assessment end points. One of the key points made during the conference concerned the special challenges for kids with celiac disease, including lower rates of compliance with a gluten-free diet.
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Alessio Fasano, MD, director of the Center for Celiac Research at MassGeneral Hospital for Children, in Boston, said that the data shows that only about 1 in 3 of adults with celiac disease are compliant with a gluten-free diet, with lower compliance in children. Because of this, he notes, "there is an even stronger need for pharmacologic therapies than in the pediatric population than in the adult population."
Kids want to "fit in," says Dr. Fassano, and so providing "a pharmacologic safety net for children who want to attend a birthday party or sleepover, so that they do not have to worry about what they eat, could make a huge difference in their lives."
College students are another high-risk group for noncompliance, and many campus cafeterias still struggle to provide safe gluten-free diets. He noted that although repeated endoscopies are recommended for monitoring celiac disease in adults, they are not advised in children.
Overall, it seems that children and young people might be the main beneficiaries of drug treatments for celiac disease, though anyone with high sensitivity and a risk of gluten contamination would also likely benefit form such therapies.
As a whole, the group in attendance seemed to be in agreement that, while much work remains to advance the treatment of celiac disease, researchers "know more about this inflammatory disease than virtually any other disease in the immune category. We should be able to come up with alternatives to a gluten-free diet."
What do you think? Would you welcome an alternative to a gluten-free diet for your celiac disease?
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