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Contrary to previous belief, it is now proven that the gluten-free diet (GFD) is not only a burden, but it is also ineffective for many patients. As a result of the difficulty in maintaining total avoidance of gluten while on a GFD, gluten contamination results in 50% or more of all diagnosed celiac patients continuing to have an active disease.
Patients who continue to have symptoms despite attempting to maintain a gluten-free diet are deemed to have diet non-responsive celiac disease. This is defined as persistent symptoms, signs or laboratory abnormalities typical of celiac disease despite 6–12 months of dietary gluten avoidance. The hypotheses to explain the sustained disease activity in many patients on a GFD include the potential for greater sensitivity to gluten in some patients and, particularly, continued gluten exposure given that it is virtually impossible to avoid gluten contamination in modern societies.
While rare (approximately 1 in 200 patients), the most serious complication of celiac disease is the development of a small bowel gastrointestinal T-cell lymphoma after many years of exposure to gluten. This malignant condition, which is no longer dependent of gluten or responsive to a gluten-free diet (GFD), is termed refractory celiac disease Type II (RCD-II). One in two patients with RCD-II will develop enteropathy-associated T cell lymphoma (EATL), which typically has a very poor prognosis and more than 50% mortality in many studies.
The treatment of RCD-II is difficult. Abnormal malignant lymphocytes are scattered in the whole small intestinal epithelium and usually in the stomach and colon, thereby precluding surgery. The prognosis of RCD-II is poor with death occurring within 3-10 years due to intractable diarrhea and/or high-grade lymphomas or, more rarely, metastasis of the low-grade proliferation to other tissues (e.g., skin, lungs). The treatment of high-grade lymphoma relies on surgical resection and chemotherapy, but the prognosis is very poor. An effective treatment for RCD-II remains one of the highest priorities.