title: Vedolizumab Induces Long-term Mucosal Healing in Patients With Crohn's Disease and Ulcerative Colitis.
abstract: BACKGROUND
  Vedolizumab has proven efficacy in inflammatory bowel disease [IBD], but long-term mucosal healing in Crohn's disease [CD], as well as the incidence of colorectal neoplasia in IBD, among patients treated with vedolizumab have not been studied. We aimed to document mucosal healing and to explore the risk of colorectal neoplasia with vedolizumab maintenance therapy.
  
  
  METHODS
  Surveillance colonoscopy was prospectively scheduled for patients with longstanding ulcerative coltis [UC] or CD at a tertiary referral centre, in the open-label extension phase (vedolizumab 300 mg intravenously [IV] every 4 weeks) of the Gemini studies [GEMINI LTS, study number NCT00790933]. Mayo score ≤ 1 or ulcer disappearance [in CD] was defined as mucosal healing. Targeted biopsies were graded for inflammation and dysplasia.
  
  
  RESULTS
  Of 68 patients [29 CD/39 UC] treated for ≥ 1 year [median 3.2 years, range 1.1-6.1], 58 [24 CD/34 UC] were endoscopically monitored. Durable endoscopic healing corrected by non-responder imputation was found in 7/24, 29% [CD] and 17/34, 50% [UC]. Combined histological and mucosal healing was observed in 5/24 [CD] and 11/34 [UC] of those with endoscopic healing. Low-grade dysplasia was detected in 10% of patients and high-grade dysplasia in the resection specimen of one patient with biopsy-proven low-grade dysplasia.
  
  
  CONCLUSIONS
  Long-term endoscopic and histological healing was observed in a proportion of patients treated with vedolizumab long-term. The dysplasia risk with vedolizumab deserves further study.
authors.affiliation: Division of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.
authors.forename: Maja
authors.initials: M
authors.lastname: Noman
authors.affiliation: Division of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.|TARGID, KULeuven, Leuven, Belgium.
authors.forename: Marc
authors.initials: M
authors.lastname: Ferrante
authors.affiliation: Division of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.
authors.forename: Raf
authors.initials: R
authors.lastname: Bisschops
authors.affiliation: Division of Pathology, University Hospital Leuven, Leuven, Belgium.
authors.forename: Gert
authors.initials: G
authors.lastname: De Hertogh
authors.affiliation: Division of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.
authors.forename: Karolien
authors.initials: K
authors.lastname: Van den Broeck
authors.affiliation: Division of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.
authors.forename: Karen
authors.initials: K
authors.lastname: Rans
authors.affiliation: Division of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
authors.affiliation: Division of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.|TARGID, KULeuven, Leuven, Belgium.
authors.forename: Séverine
authors.initials: S
authors.lastname: Vermeire
authors.affiliation: Division of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.|TARGID, KULeuven, Leuven, Belgium.
authors.forename: Gert
authors.initials: G
authors.lastname: Van Assche
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000517:prevention & control; D000293:Adolescent; D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000494:pharmacology / Q000627:therapeutic use*; D001706:Biopsy; D003093:Colitis, Ulcerative / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000473:pathology / Q000517:prevention & control; D003424:Crohn Disease / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007275:Injections, Intravenous; D007413:Intestinal Mucosa / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D011230:Precancerous Conditions / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000473:pathology; D012189:Retrospective Studies; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; C543529:vedolizumab
keywords: IBD; dysplasia; healing; vedolizumab