title: Combined approach with infliximab, surgery, and methotrexate in severe fistulizing anoperineal Crohn's disease: results from a prospective study.
abstract: BACKGROUND
  Infliximab is the only medical therapy that has been proven to be effective in fistulizing Crohn's disease (CD), but the recurrence rate of fistulas is high despite maintenance therapy. The aim of this prospective study was to evaluate the short- and long-term efficacy of a combined schedule with infliximab, methotrexate, and sphincter-sparing surgery in patients with severe fistulizing anoperineal CD.
  
  
  METHODS
  From January 2006 to November 2007, all consecutive patients in three referral centers with severe fistulizing anoperineal CD were prospectively included after primary drainage. At inclusion, patients received three infliximab infusions at weeks 0, 2, and 6, and maintenance therapy with methotrexate. A second optimized surgical step consisting of at least removal of setons was performed between the second and the third infliximab infusions.
  
  
  RESULTS
  Thirty-four CD patients (26 women; median age 38.5 years) with complex anoperineal fistula were enrolled (including 9 with recto-vaginal fistulas, and 10 with anorectal stenosis). At week 14 the response rate was 85% with 74% complete responders. At 1 year, 50% were still responders; luminal CD worsening was the major cause of relapse. Median Perineal Disease Activity Index (PDAI) and magnetic resonance imaging (MRI) scores significantly decreased from baseline to week 50.
  
  
  CONCLUSIONS
  A combined approach with infliximab induction, two surgical sphincter-sparing steps and methotrexate is effective in achieving short-term response in severe fistulizing anoperineal CD. The best maintenance regimen remains to be determined.
authors.affiliation: CHU de Bordeaux, Hôpital Haut-Lévêque, Service d'Hépato-gastroentérologie, Pessac, France.
authors.forename: Pauline
authors.initials: P
authors.lastname: Roumeguère
authors.forename: Dominique
authors.initials: D
authors.lastname: Bouchard
authors.forename: François
authors.initials: F
authors.lastname: Pigot
authors.forename: Alain
authors.initials: A
authors.lastname: Castinel
authors.forename: Frederic
authors.initials: F
authors.lastname: Juguet
authors.forename: Delphine
authors.initials: D
authors.lastname: Gaye
authors.forename: Maylis
authors.initials: M
authors.lastname: Capdepont
authors.forename: Frank
authors.initials: F
authors.lastname: Zerbib
authors.forename: David
authors.initials: D
authors.lastname: Laharie
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001004:Anus Diseases / Q000150:complications / Q000601:surgery / Q000628:therapy*; D003131:Combined Modality Therapy; D003424:Crohn Disease / Q000150:complications / Q000601:surgery / Q000628:therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D000069285:Infliximab; D007412:Intestinal Fistula / Q000150:complications / Q000601:surgery / Q000628:therapy*; D008279:Magnetic Resonance Imaging; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D010502:Perineum / Q000473:pathology* / Q000601:surgery; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D007166:Immunosuppressive Agents; D000069285:Infliximab; D008727:Methotrexate