Can endoscopy be avoided in the assessment of ulcerative colitis in clinical trials?

Inflammatory Bowel Diseases

Volumn 18, Issue 11, 2012, Pages 2056-2062

  Dhanda, Ashwin D ^a,b   Creed, Tom J ^a   Greenwood, Rosemary ^b   Sands, Bruce E ^c   Probert, Christopher S ^a,b  

^a UNIVERSITY OF BRISTOL   (United Kingdom)

^b UNIVERSITY HOSPITALS BRISTOL NHS FOUNDATION TRUST   (United Kingdom)

^c MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

clinical disease activity; endoscopy; Mayo score; ulcerative colitis

Indexed keywords

ARTICLE; DISEASE ACTIVITY; ENDOSCOPY; HUMAN; HUMAN CELL; HUMAN TISSUE; MAJOR CLINICAL STUDY; NON INVASIVE MEASUREMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIGMOIDOSCOPY; ULCERATIVE COLITIS;

COLITIS, ULCERATIVE; HUMANS; REGRESSION ANALYSIS; SEVERITY OF ILLNESS INDEX; SIGMOIDOSCOPY;

EID: 84861191288     PISSN: 10780998     EISSN: 15364844     Source Type: Journal    
DOI: 10.1002/ibd.22879     Document Type: Article

References (38)

1. D'Haens G, Sandborn WJ, Feagan BG, et al. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007; 132: 763-786.
2. Walmsley RS, Ayres RC, Pounder RE, et al. A simple clinical colitis activity index. Gut. 1998; 43: 29-32.
3. Seo M, Okada M, Yao T, et al. Evaluation of the clinical course of acute attacks in patients with ulcerative colitis through the use of an activity index. J Gastroenterol. 2002; 37: 29-34.
4. Schroeder KW, Tremaine WJ, Ilstrup DM,. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987; 317: 1625-1629.
5. Sutherland LR, Martin F, Greer S, et al. 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. Gastroenterology. 1987; 92: 1894-1898.
6. Froslie KF, Jahnsen J, Moum BA, et al. Mucosal healing in inflammatory bowel disease: results from a Norwegian population-based cohort. Gastroenterology. 2007; 133: 412-422.
7. Carbonnel F, Lavergne A, Lemann M, et al. Colonoscopy of acute colitis. A safe and reliable tool for assessment of severity. Dig Dis Sci. 1994; 39: 1550-1557.
8. Zahn A, Hinz U, Karner M, et al. Health-related quality of life correlates with clinical and endoscopic activity indexes but not with demographic features in patients with ulcerative colitis. Inflamm Bowel Dis. 2006; 12: 1058-1067.
9. Rutter M, Saunders B, Wilkinson K, et al. Severity of inflammation is a risk factor for colorectal neoplasia in ulcerative colitis. Gastroenterology. 2004; 126: 451-459.
10. Rutter MD, Saunders BP, Wilkinson KH, et al. Cancer surveillance in longstanding ulcerative colitis: endoscopic appearances help predict cancer risk. Gut. 2004; 53: 1813-1816.
11. Kruis W, Kiudelis G, Racz I, et al. Once daily versus three times daily mesalazine granules in active ulcerative colitis: a double-blind, double-dummy, randomised, non-inferiority trial. Gut. 2009; 58: 233-240.
12. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005; 353: 2462-2476.
13. Beattie RM, Nicholls SW, Domizio P, et al. Endoscopic assessment of the colonic response to corticosteroids in children with ulcerative colitis. J Pediatr Gastroenterol Nutr. 1996; 22: 373-379.
14. Dick AP, Holt LP, Dalton ER,. Persistence of mucosal abnormality in ulcerative colitis. Gut. 1966; 7: 355-360.
15. Morson BC,. Rectal biopsy in inflammatory bowel disease. N Engl J Med. 1972; 287: 1337-1339.
16. Wright R, Truelove SR,. Serial rectal biopsy in ulcerative colitis during the course of a controlled therapeutic trial of various diets. Am J Dig Dis. 1966; 11: 847-857.
17. Bitton A, Peppercorn MA, Antonioli DA, et al. Clinical, biological, and histologic parameters as predictors of relapse in ulcerative colitis. Gastroenterology. 2001; 120: 13-20.
18. Gupta RB, Harpaz N, Itzkowitz S, et al. Histologic inflammation is a risk factor for progression to colorectal neoplasia in ulcerative colitis: a cohort study. Gastroenterology. 2007; 133: 1099-1105; quiz 1340-1091.
19. Reinisch W, Sandborn WJ, Bala M, et al. Response and remission are associated with improved quality of life, employment and disability status, hours worked, and productivity of patients with ulcerative colitis. Inflamm Bowel Dis. 2007; 13: 1135-1140.
20. Lewis JD, Lichtenstein GR, Deren JJ, et al. Rosiglitazone for active ulcerative colitis: a randomized placebo-controlled trial. Gastroenterology. 2008; 134: 688-695.
21. Lewis JD, Lichtenstein GR, Stein RB, et al. An open-label trial of the PPAR-gamma ligand rosiglitazone for active ulcerative colitis. Am J Gastroenterol. 2001; 96: 3323-3328.
22. Lewis JD, Chuai S, Nessel L, et al. Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis. 2008; 14: 1660-1666.
23. Turner D, Seow CH, Greenberg GR, et al. A systematic prospective comparison of noninvasive disease activity indices in ulcerative colitis. Clin Gastroenterol Hepatol. 2009; 7: 1081-1088.
24. Sands BE, Sandborn WJ, Creed TJ, et al. A randomized, double-blind, placebo-controlled trial of basiliximab with concomitant corticosteroids in steroid-refractory ulcerative colitis. Gastroenterology. 2009; 136: A-65.
25. Riley SA, Mani V, Goodman MJ, et al. Microscopic activity in ulcerative colitis: what does it mean? Gut. 1991; 32: 174-178.
26. Bland JM, Altman DG,. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986; 1: 307-310.
27. Higgins PD, Schwartz M, Mapili J, et al. Is endoscopy necessary for the measurement of disease activity in ulcerative colitis? Am J Gastroenterol. 2005; 100: 355-361.
28. Higgins PD, Leung J, Schwartz M, et al. The quantitative validation of non-endoscopic disease activity indices in ulcerative colitis. Aliment Pharmacol Ther. 2007; 25: 333-342.
29. de Lange T, Larsen S, Aabakken L,. Inter-observer agreement in the assessment of endoscopic findings in ulcerative colitis. BMC Gastroenterol. 2004; 4: 9.
30. Osada T, Ohkusa T, Yokoyama T, et al. Comparison of several activity indices for the evaluation of endoscopic activity in UC: inter- and intraobserver consistency. Inflamm Bowel Dis. 2010; 16: 192-197.
31. Travis SPL, Sandborn WJ, Colombel JF,. Developing an ulcerative colitis endoscopic index of severity (UCEIS): results of pilot phase. Gut. 2008; 57 (Suppl II): A-201.
32. Truelove SC, Richards WC,. Biopsy studies in ulcerative colitis. Br Med J. 1956; 1: 1315-1318.
33. Gomes P, du Boulay C, Smith CL, et al. Relationship between disease activity indices and colonoscopic findings in patients with colonic inflammatory bowel disease. Gut. 1986; 27: 92-95.
34. Kim B, Barnett JL, Kleer CG, et al. Endoscopic and histological patchiness in treated ulcerative colitis. Am J Gastroenterol. 1999; 94: 3258-3262.
35. Floren CH, Benoni C, Willen R,. Histologic and colonoscopic assessment of disease extension in ulcerative colitis. Scand J Gastroenterol. 1987; 22: 459-462.
36. Bentley E, Jenkins D, Campbell F, et al. How could pathologists improve the initial diagnosis of colitis? Evidence from an international workshop. J Clin Pathol. 2002; 55: 955-960.
37. Gibson PR, Fixa B, Pekarkova B, et al. Comparison of the efficacy and safety of Eudragit-L-coated mesalazine tablets with ethylcellulose-coated mesalazine tablets in patients with mild to moderately active ulcerative colitis. Aliment Pharmacol Ther. 2006; 23: 1017-1026.
38. Geboes K, Riddell R, Ost A, et al. A reproducible grading scale for histological assessment of inflammation in ulcerative colitis. Gut. 2000; 47: 404-409.