title: Agreement Between Rectosigmoidoscopy and Colonoscopy Analyses of Disease Activity and Healing in Patients With Ulcerative Colitis.
abstract: OBJECTIVE
  Endoscopy limited to the rectosigmoid colon is the standard technique used to measure endoscopic healing in ulcerative colitis (UC) clinical trials. We evaluated whether rectosigmoidoscopy adequately measures UC activity in the more proximal colon.
  
  
  METHODS
  We analyzed data from a phase 2, placebo-controlled study that evaluated the efficacy and safety of etrolizumab in patients with moderate to severely active UC who had not responded to standard therapy. Central readers determined Mayo Clinic endoscopic subscores (MCSe) and ulcerative colitis endoscopic index of severity (UCEIS) scores from the rectosigmoid and proximal colon in videos of 331 examinations performed at baseline, week 6, and week 10. Rates of endoscopic healing (MCSe ≤ 1, MCSe = 0) and scores from rectosigmoidoscopy and colonoscopy analyses were compared among 239 examinations with endoscopic assessment proximal to the rectosigmoid colon.
  
  
  RESULTS
  There was a high degree of correlation between findings from rectosigmoidoscopy vs colonoscopy in assessment of disease activity based on MCSe of 2 or higher (r = 0.84) or MCSe of 1 or higher (r = 0.96), or the UCEIS score (r = 0.92). In 230 of 239 videos, findings from rectosigmoidoscopy agreed with those from colonoscopy in the detection of active disease (MCSe ≥ 2; n = 205) or healing (MCSe ≤ 1; n = 25). In 9 videos (2 taken at baseline, 7 taken after treatment), colonoscopy found proximal disease activity not detected by rectosigmoidoscopy. Post-treatment discordance was more frequent in the placebo group, affecting assessment of efficacy at week 10. When endoscopic healing was defined as MCSe of 0, there were discordant findings from only 1 video.
  
  
  CONCLUSIONS
  There is a high degree of correlation in assessments of UC activity made by rectosigmoidoscopy vs colonoscopy. For detection of endoscopic healing (MCSe ≤ 1), colonoscopy found persistent proximal lesions in the placebo group, which affected efficacy analyses. When endoscopic healing was defined as MCSe of 0, the concordance between rectosigmoidoscopy and colonoscopy was nearly perfect.
authors.affiliation: Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: jean-frederic.colombel@mssm.edu.
authors.forename: Jean-Frédéric
authors.initials: JF
authors.lastname: Colombel
authors.affiliation: Hospital Clínic de Barcelona, Institut D'Investigacions Biomédiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Barcelona, Spain.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Ordás
authors.affiliation: Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Thomas
authors.initials: T
authors.lastname: Ullman
authors.affiliation: Department of Gastroenterology, University Hospital Leuven, Leuven, Belgium.
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
authors.affiliation: Genentech Research and Early Development, South San Francisco, California.
authors.forename: Akiko
authors.initials: A
authors.lastname: Chai
authors.affiliation: Genentech Research and Early Development, South San Francisco, California.
authors.forename: Sharon
authors.initials: S
authors.lastname: O'Byrne
authors.affiliation: Genentech Research and Early Development, South San Francisco, California.
authors.forename: Timothy T
authors.initials: TT
authors.lastname: Lu
authors.affiliation: Hospital Clínic de Barcelona, Institut D'Investigacions Biomédiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Barcelona, Spain.
authors.forename: Julián
authors.initials: J
authors.lastname: Panés
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D003093:Colitis, Ulcerative / Q000188:drug therapy / Q000473:pathology*; D003106:Colon / Q000187:drug effects / Q000473:pathology*; D003113:Colonoscopy; D004311:Double-Blind Method; D005765:Gastrointestinal Agents / Q000627:therapeutic use; D006801:Humans; D011237:Predictive Value of Tests; D012720:Severity of Illness Index; D012812:Sigmoidoscopy; D016896:Treatment Outcome; D014741:Video Recording; D014945:Wound Healing / Q000187:drug effects
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; C559198:etrolizumab
keywords: Anti-Integrin; EUCALYPTUS; IBD; Inflammatory Bowel Disease