Glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease

Gastroenterology

Volumn 146, Issue 7, 2014, Pages 1649-1658

  Lähdeaho, Marja Leena ^a   Kaukinen, Katri ^b,c   Laurila, Kaija ^a   Vuotikka, Pekka ^d   Koivurova, Olli Pekka ^e   Kärjä Lahdensuu, Tiina ^f   Marcantonio, Annette ^g   Adelman, Daniel C ^g   Mäki, Markku ^a  

^a TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

^b TAMPERE UNIVERSITY HOSPITAL   (Finland)

^c SEINÄJOKI CENTRAL HOSPITAL   (Finland)

^d Liikuntaklinikka Oulu Diakonissalaitos   (Finland)

^e FinnMedi Oy ^*  (Finland)

^f FinnMedi Oy   (Finland)

^g Alvine Pharmaceuticals Inc   (United States)

Author keywords

Clinical Trial; Drug Treatment; Duodenal Biopsy; Morphometry

Indexed keywords

AUTOANTIBODY; GLUTEN; LATIGLUTENASE; PLACEBO;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; AGED; ARTICLE; CD3+ T LYMPHOCYTE; CELIAC DISEASE; CELL DENSITY; CLINICAL ARTICLE; CONTROLLED STUDY; DETERIORATION; DIARRHEA; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DUODENUM BIOPSY; DYSPEPSIA; ERUCTATION; FATIGUE; FEMALE; FLATULENCE; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; HUMAN TISSUE; INTERVENTION STUDY; LYMPHOCYTE COUNT; MALE; NAUSEA; OPTIMAL DRUG DOSE; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; STOMACH MUCOSA INJURY; TREATMENT OUTCOME; VOMITING;

CLINICAL TRIAL; DRUG TREATMENT; DUODENAL BIOPSY; MORPHOMETRY;

ADULT; AUTOANTIBODIES; BIOLOGICAL MARKERS; BIOPSY; CELIAC DISEASE; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DUODENUM; FEMALE; FINLAND; GASTROINTESTINAL AGENTS; GLUTENS; HUMANS; INTESTINAL MUCOSA; LYMPHOCYTES; MALE; MIDDLE AGED; PEPTIDE HYDROLASES; QUALITY OF LIFE; QUESTIONNAIRES; TIME FACTORS; TREATMENT OUTCOME;

EID: 84901236224     PISSN: 00165085     EISSN: 15280012     Source Type: Journal    
DOI: 10.1053/j.gastro.2014.02.031     Document Type: Article

References (49)

1. A. Rostom, J.A. Murray, and M.F. Kagnoff The American Gastroenterological Association (AGA) Institute technical review on the diagnosis and management of celiac disease Gastroenterology 131 2006 1981 2002
2. P.R. Shewry Wheat J Bot 60 2009 1537 1553
3. M. Mäki, M.L. Lähdeaho, and O. Hällström et al. Postpubertal gluten challenge in coeliac disease Arch Dis Child 64 1989 1604 1607
4. R.M. van Overbeek, I.G. Uil-Dieterman, and I.W. Mol The daily gluten intake in relatives of patients with coeliac disease compared with that of general Dutch population Eur J Gastroenterol Hepatol 9 1997 1097 1099
5. F. Hausch, L. Shan, and N.A. Santiago et al. Intestinal digestive resistant immunodominant gliadin peptides Am J Physiol Gastrointest Liver Physiol 283 2002 G996 G1003
6. L. Shan, Ø. Molberg, and I. Parrot et al. Structural basis for gluten intolerance in celiac sprue Science 297 2002 2275 2279
7. J. Piper, and J. Gray Effect of prolyl endopeptidase on digestive resistant gliadin peptides in vivo Pharmacol Exp Ther 311 2004 213 219
8. D. Schuppan, Y. Junker, and D. Barisani Celiac disease: from pathogenesis to novel therapies Gastroenterology 137 2009 1912 1933
9. C. Midhagen, and C. Hallert High rate of gastrointestinal symptoms in celiac disease patients living on a gluten-free diet: controlled study Am J Gastroenterol 98 2003 2023 2026
10. M.T. Bardella, P. Velio, and B.M. Cesana et al. Coeliac disease: a histological follow-up study Histopathology 50 2007 465 471
11. S.K. Lee, W. Lo, and L. Memeo et al. Duodenal histology in patients with celiac disease after treatment with a gluten-free diet Gastrointest Endosc 57 2003 187 191
12. T. Ilus, M.L. Lähdeaho, and T. Salmi et al. Persistent duodenal intraepithelial lymphocytosis despite a long-term strict gluten-free diet in celiac disease Am J Gastroenterol 107 2012 1563 1569
13. N.J. Hall, G. Rubin, and A. Charnock Systematic review: adherence to a gluten-free diet in adult patients with coeliac disease Aliment Pharmacol Ther 30 2009 315 330
14. L.M. Sollid, and C. Khosla Novel therapies for celiac disease J Intern Med 269 2011 604 613
15. M.L. Lähdeaho, K. Lindfors, and L. Airaksinen et al. Recent advances in the development of new treatments for celiac disease Expert Opin Biol Ther 12 2012 1589 1600
16. M. Siegel, M.T. Bethune, and J. Gass et al. Rational design of combination enzyme therapy for celiac sprue Chem Biol 13 2006 649 658
17. M. Siegel, M. Garber, and A. Spencer et al. Safety, tolerability, and activity of ALV003: results from two phase 1 single, escalating-dose clinical trials Dig Dis Sci 57 2012 440 450
18. J.A. Tye-Din, R.P. Anderson, and R.A. French et al. The effects of ALV003predigestion of gluten on immune response and symptoms in celiac disease in vivo Clin Immunol 134 2010 289 295
19. J. Gass, M. Bethune, and M. Siegel et al. Combination enzyme therapy for gastric digestion of dietary gluten in patients with celiac sprue Gastroenterology 133 2007 472 480
20. P. Kuitunen, I. Kosnai, and E. Savilahti Morphometric study of the jejunal mucosa in various childhood enteropathies with special reference to intraepithelial lymphocytes J Pediatr Gastroenterol Nutr 1 1982 525 531
21. K.H. Holm Correlation of HLA-DR alleles to jejunal mucosal morphology in healthy first-degree relatives of coeliac disease patients Eur J Gastroenterol Hepatol 5 1993 35 39
22. M.-L. Lähdeaho, M. Mäki, and K. Laurila et al. Small-bowel mucosal changes and antibody responses after low- and moderate-dose gluten challenge in celiac disease BMC Gastroenterol 11 2011 129
23. J. Taavela, O. Koskinen, and H. Huhtala et al. Validation of morphometric analyses of small intestinal biopsy readouts in celiac disease 2013 PLoS One 8 2013 e76163
24. R.A. Risdon, and J.W. Keeling Quantitation of the histological changes found in small intestinal biopsy specimens from children with suspected coeliac disease Gut 15 1974 9 18
25. K. Kaukinen, M. Peräaho, and P. Collin et al. Small-bowel mucosal transglutaminase 2-specific IgA deposits in coeliac disease without villous atrophy: a prospective and randomized clinical study Scand J Gastroenterol 40 2005 564 572
26. K. Holm, M. Mäki, and E. Savilahti et al. Intraepithelial gamma/delta T-cell-receptor lymphocytes and genetic susceptibility to coeliac disease Lancet 339 1992 1500 1503
27. I.R. Korponay-Szabo, T. Halttunen, and Z. Szalai et al. In vivo targeting of intestinal and extraintestinal transglutaminase 2 by coeliac autoantibodies Gut 53 2004 641 648
28. S. Sulkanen, T. Halttunen, and K. Laurila et al. Tissue transglutaminase autoantibody enzyme-linked immunosorbent assay in detecting celiac disease Gastroenterology 115 1998 1322 1328
29. J. Svedlund, I. Sjödin, and G. Dotevall GSRS - a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease Dig Dis Sci 33 1988 129 134
30. E. Dimenäs, H. Glise, and B. Hallerbäck et al. Quality of life in patients with upper gastrointestinal symptoms. An improved evaluation of treatment regimens? Scand J Gastroenterol 28 1993 681 687
31. W. Häuser, J. Gold, and A. Stallmach et al. Development and validation of Celiac Disease Questionnaire (CDQ), a disease-specific health-related quality of life measure for adult patients with celiac disease J Clin Gastroenterol 41 2007 157 166
32. W. Häuser, F. Musial, and W.F. Caspary et al. Predictors of irritable bowel-type symptoms and healthcare-seeking behavior among adults with celiac disease Psychosom Med 69 2007 370 376
33. C. McHorney, J. Ware, and J. Lu et al. The MOS-36-item Short-Form Health Survey (SF-36): II. Tests of data quality, scaling assumptions and reliability across diverse patient groups Med Care 32 1994 40 66
34. C. O'Leary, P. Wieneke, and M. Healy et al. Celiac disease and the transition from childhood to adulthood: a 28-year follow-up Am J Gastroenterol 99 2004 2437 2441
35. I. Aziz, K.E. Evans, and V. Papageorgiou et al. Are patients with coeliac disease seeking alternative therapies to a gluten-free diet? J Gastrointestin Liver Dis 20 2011 27 31
36. A. Rubio-Tapia, I.D. Hill, and C.P. Kelly et al. ACG clinical guidelines: diagnosis and management of celiac disease Am J Gastroenterol 108 2013 656 676
37. K. Kaukinen, M. Peräaho, and K. Lindfors et al. Persistent small bowel mucosal villous atrophy without symptoms in coeliac disease Aliment Pharmacol Ther 25 2007 1237 1245
38. A. Rubio-Tapia, M.W. Rahim, and J.A. See et al. Mucosal recovery and mortality in adults with celiac disease after treatment with a gluten-free diet Am J Gastroenterol 105 2010 1412 1420
39. B. Lebwohl, F. Granath, and A. Ekbom et al. Mucosal healing and risk for lymphoproliferative malignancy in celiac disease Ann Intern Med 159 2013 169 175
40. M.N. Marsh, and P.T. Crowe Morphology of the mucosal lesion in gluten sensitivity Baillieres Clin Gastroenterol 9 1995 273 293
41. D.A. Leffler, C.P. Kelly, and H.Z. Abdallah et al. A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge Am J Gastroenterol 107 2012 1554 1562
42. C.P. Kelly, P.H.R. Green, and J.A. Murray et al. Larazotide acetate in patients with coelic disease undergoing a gluten challenge: a randomized placebo-controlled study Aliment Pharmacol Ther 37 2012 252 262
43. G.R. Corazza, V. Villanacci, and C. Zambelli et al. Comparison of the interobserver reproducibility with different histologic criteria used in celiac disease Clin Gastroenterol Hepatol 5 2007 838 843
44. A. Mubarak, P. Nikkels, and R. Houwen et al. Reproducibility of the histological diagnosis of celiac disease Scand J Gastroenterol 46 2011 1065 1073
45. C. Arguelles-Grande, C.A. Tennyson, and S.K. Lewis et al. Variability in small bowel histopathology reporting between different pathology practice settings: impact on the diagnosis of coeliac disease J Clin Pathol 65 2012 242 247
46. G.R. Corazza, and V. Villanacci Coeliac disease. Some considerations on the histological diagnosis J Clin Pathol 58 2005 573 574
47. D. Leffler, D. Schuppan, and K. Pallav et al. Kinetics of the histological, serological and symptomatic responses to gluten challenge in adults with coeliac disease Gut 62 2013 996 1004
48. P. Vernia, M. Di Camillo, and T. Foglietta et al. Diagnosis of lactose intolerance and the "nocebo" effect: the role of negative expectations Dig Liver Dis 42 2010 616 619
49. W. Häuser, P. Sarzi-Puttini, and T.R. Tölle et al. Placebo and nocebo responses in randomised controlled trials of drugs applying for approval for fibromyalgia syndrome treatment: systematic review and meta-analysis Clin Exp Rheumatol 30 2012 78 87