title: Efficacy and safety of natalizumab in Crohn's disease patients treated at 6 Boston academic hospitals.
abstract: BACKGROUND
  Despite trials demonstrating its efficacy, many physicians harbor concerns regarding the use of natalizumab in the treatment of patients with refractory Crohn's disease (CD). The purpose of this study was to perform a descriptive analysis of a series of CD patients not currently enrolled in a clinical trial.
  
  
  METHODS
  A retrospective case review of patients treated with natalizumab at 6 sites in Massachusetts: Boston Medical Center, Beth Israel Deaconess Medical Center, Brigham & Women's Hospital, Lahey Clinic, Massachusetts General Hospital, and UMass Medical Center.
  
  
  RESULTS
  Data on 69 CD patients on natalizumab were collected. At the start of treatment, patients' disease duration was 12 years. A high proportion of patients were women (68%), presented with perianal disease (65%) and upper gastrointestinal tract involvement (14%). Prior nonbiologic therapies were steroids (96%), thiopurines (94%), antibiotics (74%), methotrexate (58%), and at least two anti-tumor necrosis factor agent failures (81%). Sixty-nine percent (44 of 64 patients) with available medical evaluation had a partial or complete clinical response. Loss of response was 13% after an average of 1 year of treatment. Adverse events were infusion reactions, headaches, fever, and infections. No case of progressive multifocal leukoencephalopathy was observed.
  
  
  CONCLUSIONS
  In our clinical experience outside the context of a clinical trial, natalizumab is largely reserved for CD patients with extensive ileocolonic disease who have failed conventional immunosuppressants and of at least 2 anti-tumor necrosis factor agents. This drug is, however, well tolerated and offers significant clinical improvement for more than a year in one-third of these difficult-to-treat CD patients.
authors: *Department of Gastroenterology & Hepatology, MGH Crohn's & Colitis Center, Massachusetts General Hospital & Harvard Medical School, Boston, Massachusetts; †Division of Gastroenterology, Clinic of Visceral Surgery & Medicine, Bern University Hospital Inselspital, Bern, Switzerland; ‡Gastroenterology, Boston University School of Medicine, Boston, Massachusetts; §Division of Gastroenterology, Brigham & Women's Hospital, Boston, Massachusetts; ‖Gastroenterology, Lahey Clinic, Burlington, Massachusetts; ¶Gastroenterology, University of Massachusetts, Worcester, Massachusetts; and **Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors: Pascal
authors: P
authors: Juillerat
authors: Sharmeel K
authors: SK
authors: Wasan
authors: Sharyle A
authors: SA
authors: Fowler
authors: Sonia
authors: S
authors: Friedman
authors: Vikas K
authors: VK
authors: Pabby
authors: Jennifer A
authors: JA
authors: Coukas
authors: Amy E
authors: AE
authors: Barto
authors: Randall
authors: R
authors: Pellish
authors: Katharine A
authors: KA
authors: Germansky
authors: Adam S
authors: AS
authors: Cheifetz
authors: Joshua R
authors: JR
authors: Korzenik
authors: Francis A
authors: FA
authors: Farraye
authors: Vijay
authors: V
authors: Yajnik
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D001900:Boston; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D039441:Integrin alpha4 / Q000737:chemistry* / Q000276:immunology; D008297:Male; D000069442:Natalizumab; D011379:Prognosis; D012074:Remission Induction; D012189:Retrospective Studies; D012449:Safety
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D000069442:Natalizumab; D039441:Integrin alpha4