Currently, there are no approved drug treatments for celiac disease. The only option currently available for celiac disease is for patients to follow a strict, lifelong adherence to a gluten-free diet (GFD). In addition, treatment for nutritional deficiency states (e.g., iron, folate, vitamin B12) and a determination of bone mineral density to assess for osteoporosis are recommended.
Total exclusion of dietary gluten is difficult because gluten is one of the most common food ingredients. Clinical or histologic improvement is unsatisfactory in many celiac disease patients, with continued exposure to gluten being the primary cause of persistent or recurrent symptoms. Even highly motivated patients who attempt to adhere to the gluten-free diet are affected due to inadvertent or background exposure to gluten (Green 2007), and a majority of patients with celiac disease who are in clinical remission and who claim to be following a gluten-free diet have persistent abnormalities in small bowel biopsy specimens (Lee, Lo et al. 2003). Greater than 60% of celiac disease patients continue to experience persistance of celiac disease symptoms even on an attempted GFD (Canadian Celiac Health Survey, Digestive Diseases & Sciences, April 2007; 52(4): 1087-1095). Inadvertent exposure to gluten has been identified as the leading cause of non-responsive celiac disease among clinically diagnosed patients who were presumed to be on a gluten-free diet (Abulkarim, Burgart et al. 2002). Thus, there is an acute need for non-dietary therapies for celiac disease.