{"id":8396,"date":"2018-05-23T15:19:40","date_gmt":"2018-05-23T20:19:40","guid":{"rendered":"https:\/\/fomatmedical.com\/?p=8396"},"modified":"2026-05-06T15:52:40","modified_gmt":"2026-05-06T22:52:40","slug":"celiac-disease-gluten-free-diet","status":"publish","type":"post","link":"https:\/\/fomatmedical.com\/es\/blogs-updates\/celiac-disease-gluten-free-diet\/","title":{"rendered":"Un medicamento experimental alivia los efectos del gluten en pacientes cel\u00edacos que siguen una dieta sin gluten."},"content":{"rendered":"
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Celiac Disease Gluten Free Diet Patients Get Powerful New Drug Option<\/h3>\n

A new investigational drug is offering real hope for patients managing a celiac disease gluten free diet. For the first time, a Phase 2 study of a biologic immune modulator has shown that AMG 714, an antibody that blocks interleukin 15, reduces symptoms triggered by accidental gluten exposure in celiac disease gluten free diet patients. Findings were presented at Digestive Disease Week 2018. According to the Mayo Clinic<\/a>, a strict gluten free diet is currently the only available treatment for celiac disease, yet complete avoidance of gluten is nearly impossible to maintain over a lifetime.<\/p>\n

Why a Celiac Disease Gluten Free Diet Is Not Enough Alone<\/h3>\n

Despite following a celiac disease gluten free diet, an average of half of all patients continue to experience mucosal inflammation or damage, and a third have recurrent symptoms. Gluten contamination during food processing, packaging, cooking, or through inadequate labeling occurs very frequently even among the most careful patients.<\/p>\n

This gap between the treatment standard and real world outcomes is precisely what AMG 714 was designed to address. As study director Francisco Leon, MD, PhD, clarified, the drug is not intended for patients who deliberately consume large amounts of gluten. Its purpose is to protect against the modest contamination that is essentially unavoidable for anyone on a celiac disease gluten free diet.<\/p>\n

How the AMG 714 Study Was Designed<\/h3>\n

This randomized, double blind, placebo controlled Phase 2a study compared AMG 714 at two dose levels, 150 mg and 300 mg, against placebo over 12 weeks. The drug was administered six times by subcutaneous injection.<\/p>\n

One subgroup received a high dose gluten challenge of approximately 2.5 grams per day for 10 weeks. A second subgroup, who showed mucosal atrophy at baseline, were found through novel stool and urine gluten detection tests to be experiencing hidden contamination through their regular celiac disease gluten free diet and did not receive the additional challenge.<\/p>\n

3 Proven Results From the AMG 714 Trial<\/h3>\n

1. Reduced Intestinal Inflammation and Symptom Relief<\/h4>\n

AMG 714 reduced gluten triggered effects in both groups receiving the drug compared to placebo. A clear decrease in intestinal inflammation was observed, along with a trend toward reduced intestinal damage in the non-challenge group. Patient reported outcomes showed meaningful symptom reduction, particularly in the 300 mg dose group. The placebo group experienced an increase in diarrhea that was not seen in patients taking AMG 714.<\/p>\n

2. No Active Disease at Week 12 in High Dose Group<\/h4>\n

At week 12, none of the patients in the gluten challenge group who received the 300 mg dose was assessed as having active disease. By contrast, one third of the placebo group in the same subgroup did have active disease at that point. For anyone managing a celiac disease gluten free diet in daily life, this level of protection against accidental exposure represents a meaningful clinical advance.<\/p>\n

3. Strong Safety Profile With No Serious Adverse Events<\/h4>\n

There were no serious adverse events or safety signals in the study. The most frequently reported side effects included injection site reactions, headache, and upper respiratory tract infection. No dose related trends were seen except for injection site reactions, supporting the drug’s tolerability for long term celiac disease gluten free diet management.<\/p>\n

What This Means for Celiac Disease Patients<\/h3>\n

As principal investigator Markku Maki, MD, PhD, of the University of Tampere noted, complete long term gluten avoidance is not realistically achievable for most patients on a celiac disease gluten free diet. AMG 714 represents a meaningful step toward an adjunct therapy that could reduce the burden of accidental exposure and improve quality of life for millions living with this condition.<\/p>\n

FOMAT conducts Phase I through Phase IV clinical research across a national network of investigator sites throughout the United States. To learn more about active gastroenterology studies, visit our patient active studies page<\/a>.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Los pacientes con enfermedad cel\u00edaca que siguen una dieta sin gluten cuentan con una nueva y eficaz opci\u00f3n farmacol\u00f3gica. Un nuevo f\u00e1rmaco en fase de investigaci\u00f3n ofrece una esperanza real a los pacientes que siguen una dieta sin gluten para controlar la enfermedad cel\u00edaca. Por primera vez, un estudio de fase II de un modulador inmunol\u00f3gico biol\u00f3gico\u2026<\/p>","protected":false},"author":3,"featured_media":111189,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[968],"tags":[],"class_list":["post-8396","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs-updates"],"acf":[],"_links":{"self":[{"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/posts\/8396","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/comments?post=8396"}],"version-history":[{"count":0,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/posts\/8396\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/media\/111189"}],"wp:attachment":[{"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/media?parent=8396"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/categories?post=8396"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/tags?post=8396"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}