How future pharmacological therapies for celiac disease will complement the gluten-free diet.

The only proven treatment for celiac disease is adherence to a strict, lifelong, gluten free diet. However, complete dietary gluten avoidance is challenging and a substantial number of patients do not respond fully, clinically or histologically, despite their best efforts. As celiac disease is common and its central pathophysiology is well elucidated, it has become attractive for drug development to address the limitations of dietary treatment. Most efforts address non-responsive celiac disease, defined as continued symptoms and/or signs of disease activity despite a gluten free diet, including the more severe forms of refractory celiac disease type 1 and 2. An increasing spectrum of therapeutic approaches target defined mechanisms in celiac disease pathogenesis, and some currently advance to phase 2-3 clinical studies. We discuss these approaches in terms of potential efficiency, practicability, safety and need as defined by patients, regulatory authorities, health care providers and payors.