title: Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn's disease following treatment with certolizumab pegol.
abstract: OBJECTIVE
  To evaluate the efficacy of certolizumab pegol (CZP) in improving endoscopic lesions in patients with active ileocolonic Crohn's disease (CD).
  
  
  METHODS
  This phase IIIB multicentre open-label clinical trial enrolled 89 adult patients with active endoscopic disease (ulceration in ≥2 intestinal segments with a Crohn's Disease Endoscopic Index of Severity (CDEIS) score ≥8 points). Patients received subcutaneous CZP 400 mg at weeks 0, 2 and 4 and every 4 weeks up to week 52. Endoscopic evaluations were performed at weeks 0, 10 and 54. The primary outcome was mean change in CDEIS score at week 10; secondary outcome measures included endoscopic response (decrease in CDEIS score >5 points), remission (CDEIS score <6), complete remission (CDEIS score <3) and mucosal healing (no ulcer) at weeks 10 and 54.
  
  
  RESULTS
  In the intention-to-treat population (n=89) the mean±SD CDEIS score was 14.5±5.3 at baseline; the mean decrease in CDEIS score at week 10 was 5.7 (95% CI 4.6 to 6.8, p<0.0001). Rates of endoscopic response, endoscopic remission, complete endoscopic remission and mucosal healing at week 10 were 54%, 37%, 10% and 4%, respectively. At week 54 the corresponding rates were 49%, 27%, 14% and 8%, respectively. The safety profile was consistent with that of previous CZP trials.
  
  
  CONCLUSIONS
  Following CZP treatment in patients with active CD, endoscopic lesions were improved as shown by the decrease in mean CDEIS score and by endoscopic response and remission rates. These benefits were achieved as early as week 10 and were generally maintained through week 54.
  
  
  BACKGROUND
  NCT00297648.
authors.affiliation: CHU Nice, INSERM ERI-21, EA4319, University of Nice Sophia-Antipolis, Nice, France. xavier.hebuterne@unice.fr
authors.forename: Xavier
authors.initials: X
authors.lastname: Hébuterne
authors.forename: Marc
authors.initials: M
authors.lastname: Lémann
authors.forename: Yoram
authors.initials: Y
authors.lastname: Bouhnik
authors.forename: Olivier
authors.initials: O
authors.lastname: Dewit
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Dupas
authors.forename: Michael
authors.initials: M
authors.lastname: Mross
authors.forename: Geert
authors.initials: G
authors.lastname: D'Haens
authors.forename: Krassimir
authors.initials: K
authors.lastname: Mitchev
authors.forename: Étienne
authors.initials: É
authors.lastname: Ernault
authors.forename: Séverine
authors.initials: S
authors.lastname: Vermeire
authors.forename: Hedia
authors.initials: H
authors.lastname: Brixi-Benmansour
authors.forename: Tom G
authors.initials: TG
authors.lastname: Moreels
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Mary
authors.forename: Philippe
authors.initials: P
authors.lastname: Marteau
authors.forename: Jean-Frédéric
authors.initials: JF
authors.lastname: Colombel
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D000068582:Certolizumab Pegol; D003424:Crohn Disease / Q000175:diagnosis / Q000188:drug therapy*; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D007279:Injections, Subcutaneous; D007413:Intestinal Mucosa / Q000187:drug effects* / Q000473:pathology; D008297:Male; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007140:Immunoglobulin Fab Fragments; D011092:Polyethylene Glycols; D000068582:Certolizumab Pegol