| [1] | Rubio-Tapia A, Ludvigsson JF, Brantner TL, Murray JA, Everhart JE. The prevalence of celiac disease in the United States. Am J Gastroenterol. 2012 Oct; 107(10): 1538-44. |
| |
| [2] | Fasano A, Berti I, Gerarduzzi T, Not T, Colletti RB, Drago S, Elitsur Y, Green PH, Guandalini S, Hill ID, Pietzak M, Ventura A, Thorpe M, Kryszak D, Fornaroli F, Wasserman SS, Murray JA, Horvath K. Prevalence of celiac disease in at-risk and not-at-risk groups in the United States: a large multicenter study. Arch Intern Med. 2003 Feb 10; 163(3): 286-92. |
| |
| [3] | Chou R, Bougatsos C, Blazina I, Mackey K, Grusing S, Selph S. Screening for Celiac Disease: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2017 Mar 28; 317(12): 1258-1268. |
| |
| [4] | Nguyen V, Sweet BV, Macek T. Defining the phases of clinical trials. Am J Health Syst Pharm. 2006 Apr 15;63(8):710-1. |
| |
| [5] | Rados C. Inside clinical trials: testing medical products in people. FDA Consum. 2003; 37(5): 30-5. |
| |
| [6] | Lähdeaho ML, Kaukinen K, Laurila K, et al. Glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease. Gastroenterology. 2014 Jun; 146(7): 1649-58. |
| |
| [7] | Gass, J., Bethune, M., Siegel, M. et al. Combination enzyme therapy for gastric digestion of dietary gluten in patients with celiac sprue. Gastroenterology. 2007; 133: 472-480. |
| |
| [8] | Syage JA, Murray JA, Green PHR, Khosla C. Latiglutenase Improves Symptoms in Seropositive Celiac Disease Patients While on a Gluten-Free Diet. Dig Dis Sci. 2017 Sep; 62(9): 2428-2432. |
| |
| [9] | Murray JA, Kelly CP, Green PHR, Marcantonio A, Wu TT, Mäki M, Adelman DC; CeliAction Study Group of Investigators. No Difference Between Latiglutenase and Placebo in Reducing Villous Atrophy or Improving Symptoms in Patients With Symptomatic Celiac Disease. Gastroenterology. 2017 Mar; 152(4): 787-798. e2. |
| |
| [10] | Viokace (pancrelipase) [package insert]. Allergan Inc., Irvine, CA; 2017. |
| |
| [11] | Creon (pancrelipase) [package insert]. Abbott Laboratories, North Chicago, IL; 2012. |
| |
| [12] | Zenpep (pancrelipase) [package insert]. Aptalis Pharma US, Inc., Bridgewater, NJ; 2014. |
| |
| [13] | Pertyze (pancrelipase) [package insert]. Digestive Care, Inc., Bethlehem, PA; 2017. |
| |
| [14] | Pancreaze (pancrelipase) [package insert]. Janssen Pharmaceuticals, Inc., Titusville, NJ; 2018. |
| |
| [15] | Goel G., King T., Daveson A.J., et al. Epitope-specific immunotherapy targeting CD4-positive T cells in coeliac disease: two randomised, double-blind, placebo-controlled phase 1 studies. Lancet Gastroenterol. Hepatol. 2017; 2: 479-493. |
| |
| [16] | Daveson AJM, Ee HC, Andrews JM, et al. Epitope-Specific Immunotherapy Targeting CD4-Positive T Cells in Celiac Disease: Safety, Pharmacokinetics, and Effects on Intestinal Histology and Plasma Cytokines with Escalating Dose Regimens of Nexvax2 in a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. EBioMedicine. 2017; 26: 78-90. |
| |
| [17] | Karell K., Louka A.S., Moodie S.J., et al. European Genetics Cluster on Celiac Disease HLA types in celiac disease patients not carrying the DQA1*05-DQB1*02 (DQ2) heterodimer: results from the European Genetics Cluster on Celiac Disease. Hum. Immunol. 2003; 64: 469-477. |
| |
| [18] | Anderson R.P., Jabri B. Vaccine against autoimmune disease: antigen-specific immunotherapy. Curr. Opin. Immunol. 2013; 25: 410-417 |
| |
| [19] | Theron M, Bentley D, Nagel S, et al. Pharmacodynamic Monitoring of RO5459072, a Small Molecule Inhibitor of Cathepsin S. Frontiers in Immunology. 2017; 8: 806. |
| |
| [20] | Waldmann TA. The biology of IL-15: implications for cancer therapy and the treatment of autoimmune disorders. J Investig Dermatol Symp Proc. 2013 Dec; 16(1): S28-30. |
| |
| [21] | Daveson AJ, Jones DM, Gaze S, et al. Effect of Hookworm Infection on Wheat Challenge in Celiac Disease – A Randomised Double-Blinded Placebo Controlled Trial. Gluud LL, ed. PLoS ONE. 2011; 6(3): e17366. |
| |
| [22] | Howland RH. How are drugs approved? Part 1: the evolution of the Food and Drug Administration. J Psychosoc Nurs Ment Health Serv. 2008 Jan; 46(1): 15-9. |
| |
| [23] | Borrelli EP. Trends in Hospitalizations for Celiac Disease in the United States. International Journal of Celiac Disease. 2017 Nov; 5(4): 150-154. |
| |
| [24] | Abdulla A, Garemo M. High cost of gluten free products might be challenging for people with celiac disease in the United Arab Emirates. 2018 May; 6(2): ahead of print. |
| |