Long-term follow-up of the red density pilot trial: a basis for long-term prediction of sustained clinical remission in ulcerative colitis?

Abstract

Red density (RD) technology is an automated operator-independent endoscopic scoring system for disease activity in ulcerative colitis (UC). In this retrospective analysis we aimed to assess the predictive value of the RD sore for sustained clinical remission. All 39 patients from the RD pilot trial were evaluated for clinical outcome in a 5-year period. The highest RD score was considered for Receiver operating characteristic (ROC) analysis to determine the cut-off of the RD for the composite endpoint of treatment failure (defined as mortality, colectomy, hospitalizations, flares and UC therapy changes). Statistical significance was considered P < 0.05. Reassessment of the RD score was possible in 36 patients. The composite endpoint was reached in 17 of 39 patients. ROC analysis for clinical remission showed a RD cut-off of 65, area under the ROC was 0.68, sensitivity of 0.71, and a specificity of 0.63. A RD score of ≥ 65 demonstrated a statistically non-significant increase in composite endpoint (hazard ratio 0.49 (95% confidence interval 0.1871-1.280); P = 0.1453). In conclusion, the RD score may be an independent predictor of clinical remission in patients with UC for the disease course up to 5 years, but results of the ongoing PROCEED-UC trial are to awaited for definite conclusions.

Keywords

Endoscopy Upper GI Tract - Diagnosis and imaging (inc chromoendoscopy, NBI, iSCAN, FICE, CLE) - Endoscopy Lower GI Tract - Inflammatory bowel disease - Quality and logistical aspects - Quality management

Publication History

Received: 29 March 2023

Accepted after revision: 10 August 2023

Accepted Manuscript online:
14 August 2023

Article published online:
27 September 2023

• References

• 1 Colombel JF, Rutgeerts P, Reinisch W. et al. Early mucosal healing with infliximab is associated with improved long-term clinical outcomes in ulcerative colitis. Gastroenterology 2011; 141: 1194-1201
• 2 Shah SC, Colombel J-F, Sands BE. et al. Mucosal healing is associated with improved long-term outcomes of patients with ulcerative colitis: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2016; 14: 1245-1255
• 3 Ardizzone S, Cassinotti A, Duca P. et al. Mucosal healing predicts late outcomes after the first course of corticosteroids for newly diagnosed ulcerative colitis. Clinical Gastroenterol Hepatol 2011; 9: 483-489 DOI: 10.1016/j.cgh.2010.12.028. (PMID: 21195796)
• 4 Osada T, Ohkusa T, Yokoyama T. et al. Comparison of several activity indices for the evaluation of endoscopic activity in UC: Inter- and intra-observer consistency. Inflamm Bowel Dis 2010; 16: 192-197
• 5 Vuitton L, Peyrin-Biroulet L, Colombel JF. et al. Defining endoscopic response and remission in ulcerative colitis clinical trials: an international consensus. Aliment Pharmacol Ther 2017; 45: 801-813 DOI: 10.1111/apt.13948. (PMID: 28112419)
• 6 Barreiro-de Acosta M, Vallejo N, de la Iglesia D. et al. Evaluation of the risk of relapse in ulcerative colitis according to the degree of mucosal healing (Mayo 0 vs 1): a longitudinal cohort study. J Crohns Colitis 2016; 10: 13-19
• 7 Boal Carvalho P, Dias de Castro F, Rosa B. et al. Mucosal healing in ulcerative colitis--when zero is better. J Crohns Colitis 2016; 10: 20-25
• 8 Bessissow T, Lemmens B, Ferrante M. et al. Prognostic value of serologic and histologic markers on clinical relapse in ulcerative colitis patients with mucosal healing. Am J Gastroenterol 2012; 107: 1684-1692
• 9 Bossuyt P, Nakase H, Vermeire S. et al. Automatic, computer-aided determination of endoscopic and histological inflammation in patients with mild to moderate ulcerative colitis based on red density. Gut 2020; 69: 1778-1786
• 10 Takenaka K, Ohtsuka K, Fujii T. et al. Deep neural network accurately predicts prognosis of ulcerative colitis using endoscopic images. Gastroenterology 2021; 160: 2175-2177 DOI: 10.1053/j.gastro.2021.01.210. (PMID: 33485853)