title: Efficacy of adalimumab in patients with Crohn's disease and symptomatic small bowel stricture: a multicentre, prospective, observational cohort (CREOLE) study.
abstract: The efficacy of anti-tumour necrosis factors (anti-TNFs) in patients with Crohn's disease (CD) and symptomatic small bowel stricture (SSBS) is controversial. The aim of this study was to estimate the efficacy of adalimumab in these patients and to identify the factors predicting success.
  
  
  
  We performed a multicentre, prospective, observational cohort study in patients with CD and SSBS. The included patients underwent magnetic resonance enterography at baseline and subsequently received adalimumab. The primary endpoint was success at week 24, defined as adalimumab continuation without prohibited treatment (corticosteroids after the eight week following inclusion, other anti-TNFs), endoscopic dilation or bowel resection. The baseline factors independently associated with success were identified using a logistic regression model, leading to a simple prognostic score. Secondary endpoints were prolonged success after week 24 (still on adalimumab, without dilation nor surgery) and time to bowel resection in the whole cohort.
  
  
  
  From January 2010 to December 2011, 105 patients were screened and 97 were included. At week 24, 62/97 (64%) patients had achieved success. The prognostic score defined a good prognosis group with 43/49 successes, an intermediate prognosis group with 17/28 successes and a poor prognosis group with 1/16 successes. After a median follow-up time of 3.8 years, 45.7%±6.6% (proportion±SE) of patients who were in success at week 24 (ie, 29% of the whole cohort) were still in prolonged success at 4 years. Among the whole cohort, 50.7%±5.3% of patients did not undergo bowel resection 4 years after inclusion.
  
  
  
  A successful response to adalimumab was observed in about two-thirds of CD patients with SSBS and was prolonged in nearly half of them till the end of follow-up. More than half of the patients were free of surgery 4 years after treatment initiation.
  
  
  
  NCT01183403; Results.
authors.affiliation: Gastroentérologie, MICI et Assistance Nutritive, Hôpital Beaujon, Clichy, France.
authors.forename: Yoram
authors.initials: Y
authors.lastname: Bouhnik
authors.affiliation: Gastro-entérologie, Hôpital Bicêtre, Le Kremlin Bicêtre, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Carbonnel
authors.affiliation: Hépato-gastroentérologie et d'oncologie digestive, Hôpital Haut-Lévêque, Pessac, France.
authors.forename: David
authors.initials: D
authors.lastname: Laharie
authors.affiliation: Gastroentérologie, MICI et Assistance Nutritive, Hôpital Beaujon, Clichy, France.
authors.forename: Carmen
authors.initials: C
authors.lastname: Stefanescu
authors.affiliation: Gastro-Entérologie & Nutrition Clinique, Hopital de l'Archet 2, Nice, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Hébuterne
authors.affiliation: Gastro Enterologie, Hôpital Cochin, Paris, France.
authors.forename: Vered
authors.initials: V
authors.lastname: Abitbol
authors.affiliation: Maladies de l'appareil digestif et nutrition, Hôpital Claude Huriez, Lille, France.
authors.forename: Maria
authors.initials: M
authors.lastname: Nachury
authors.affiliation: Gastro Enterologie, Hôpital Robert Debré, Reims, France.
authors.forename: Hedia
authors.initials: H
authors.lastname: Brixi
authors.affiliation: Hépato-gastro-entérologie et cancérologie digestive, Hôpital Hôtel Dieu, Nantes, France.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Bourreille
authors.affiliation: Hépato-Gastro-Onco-Entérologie, Hôpital Trousseau, Tours, France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Picon
authors.affiliation: Gastroentérologie & Nutrition, Hôpital Saint-Antoine, Paris, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Bourrier
authors.affiliation: Hépato-gastroentérologie, Hôpital Saint-Louis, Paris, France.
authors.forename: Matthieu
authors.initials: M
authors.lastname: Allez
authors.affiliation: Hépato Gastro-Entérologie, Hôpital de Brabois, Nancy, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Peyrin-Biroulet
authors.affiliation: Gastro-entérologie et Nutrition, Hôpital Rangueil, Toulouse, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Moreau
authors.affiliation: Hépato-gastro-entérologie et de nutrition, Hôpital Charles Nicolle, Rouen, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Savoye
authors.affiliation: Hépato-Gastroentérologie, Hôpital Nord, Amiens, France.
authors.forename: Mathurin
authors.initials: M
authors.lastname: Fumery
authors.affiliation: Hépato-gastro-entérologie, Centre Hospitalier Lyon-Sud, Lyon, France.
authors.forename: Stephane
authors.initials: S
authors.lastname: Nancey
authors.affiliation: Gastro-entérologie et Hépatologie, CHU Saint-Etienne, Saint-Etienne, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Roblin
authors.affiliation: Hépato-gastro-entérologie, Hôpital Saint Eloi, Montpellier, France.
authors.forename: Romain
authors.initials: R
authors.lastname: Altwegg
authors.affiliation: Maladies de l'appareil digestif, Hôpital Pontchaillou, Rennes, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Bouguen
authors.affiliation: Hépatologie Gastro-Entérologie, CHU Estain, Clermont Ferrand, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Bommelaer
authors.affiliation: Instituto Clinico Humanitas-Department of Gastroenterology, Milan, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Danese
authors.affiliation: Gastro-entérologie, CHU Sart Tilman, Liege University, Liege, Belgium.
authors.forename: Edouard
authors.initials: E
authors.lastname: Louis
authors.affiliation: Radiologie, Hôpital Beaujon, Clichy, France.
authors.forename: Magaly
authors.initials: M
authors.lastname: Zappa
authors.affiliation: UMR-S-1153 Inserm, Denis Diderot-Paris 7 university, Hôpital Saint-Louis, Paris, France.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Mary
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007415:Intestinal Obstruction / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology; D007421:Intestine, Small / Q000000981:diagnostic imaging; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab
keywords: ABDOMINAL MRI; CROHN'S DISEASE; IBD CLINICAL