title: Natalizumab in Crohn's disease: results from a US tertiary inflammatory bowel disease center.
abstract: BACKGROUND
  Natalizumab is an efficacious agent for the induction and maintenance of remission in patients with Crohn's disease (CD) who have failed anti-tumor necrosis factor (TNF) agents. We aimed to assess the efficacy and safety of natalizumab outside of clinical trial at a US tertiary center.
  
  
  METHODS
  Retrospective case review of patients with CD receiving natalizumab.
  
  
  RESULTS
  Forty-nine patients with CD (28 women; median age, 33 years) receiving natalizumab from April 2008 to November 2011 were identified. Median duration of disease was 180 months (range, 36-576 months); 40 patients had ileocolonic disease, 1 had ileal disease, and 8 had colonic disease. Twenty-one patients had penetrating disease, and 28 had a history of CD-related surgical treatment. Forty-seven patients previously failed treatment with at least 1 anti-TNF agent. Median duration of natalizumab treatment was 7 months (interquartile range, 3-21.5 months). Twenty-four patients (49%) were continuing natalizumab at the time of this review, and 25 discontinued treatment because of the lack of response, side effects, or positive JC virus antibody. Seventeen patients (35%) successfully continued treatment with natalizumab for longer than 12 months, and nonpenetrating disease phenotype was identified as a predictor of longer response (compared with penetrating phenotype; P = 0.013). Nine patients (18.4%) experienced adverse effects, 5 of which were serious, but no case of progressive multifocal leukoencephalopathy occurred.
  
  
  CONCLUSIONS
  This is the largest series of natalizumab-treated patients with CD. Our results show that natalizumab is an efficacious and safe treatment agent for patients refractory to anti-TNF agents and that nonpenetrating disease phenotype has more durable response over time.
authors: Inflammatory Bowel Disease Center, The University of Chicago Medicine, Chicago, Illinois 60637, USA. asakurab@medicine.bsd.uchicago.edu
authors: Atsushi
authors: A
authors: Sakuraba
authors: Kian
authors: K
authors: Keyashian
authors: Chase
authors: C
authors: Correia
authors: John
authors: J
authors: Melek
authors: Russell D
authors: RD
authors: Cohen
authors: Stephen B
authors: SB
authors: Hanauer
authors: David T
authors: DT
authors: Rubin
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D016002:Discriminant Analysis; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D000069442:Natalizumab; D012189:Retrospective Studies; D062606:Tertiary Care Centers; D016896:Treatment Outcome; D014481:United States
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D000069442:Natalizumab