title: Biological immunomodulators improve the healing rate in surgically treated perianal Crohn's fistulas.
abstract: OBJECTIVE
  The role of biological therapy in perianal fistulas associated with Crohn's disease (CD) is uncertain as available data are confused and conflicting. In order to provide some clarity to the issue we have examined a large cohort of patients with perianal fistulas and CD and stratified them according to use of biological agents.
  
  
  METHODS
  Patients with perianal Crohn's fistulas treated between June 1999 and June 2009 were stratified according to use of biological agents and outcome was examined. Healing was defined as absence of fistula or drainage. Prior to surgery perianal sepsis was eradicated with drains or setons. Endpoints were defined as either complete healing, improvement (minimal symptoms and drainage) or unhealed, as noted at subsequent outpatient follow-up. Variables assessed were age, body mass index, smoking, perineal involvement with Crohn's granuloma and type of procedure. Fisher's exact test and χ(2) test were used for analysis.
  
  
  RESULTS
  Two hundred and eighteen patients had anal fistulas and CD. Mean follow-up was 3.2±3 years with mean age 38.8±12.2years and body mass index of 25.3±6. One hundred and seventeen patients (53.7%) underwent surgery alone (Group A) and 101 patients (46.3%) underwent surgery and biological immunomodulator treatments (Group B). Demographic data and CD history were similar between groups. Surgeries included seton drainge (n=90), fistulotomy (n=22), rectal advancement flap (n=39), fistulotomy plus seton (n=47) and others (n=20). Overall improvement in Group A was in 42 patients (35.9%) vs 72 patients (71.3%) in Group B (P=0.001). There was no significant difference in other studied variables between both groups.
  
  
  CONCLUSIONS
  There is a definite role for biological therapy as an adjuvant to surgery in patients with perianal fistulas and CD.
authors.affiliation: Department of Colorectal Surgery, Digestive Disease Institute, Cleveland Clinic, Cleveland, Ohio 44195, USA.
authors.forename: G
authors.initials: G
authors.lastname: El-Gazzaz
authors.forename: T
authors.initials: T
authors.lastname: Hull
authors.forename: J M
authors.initials: JM
authors.lastname: Church
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003424:Crohn Disease / Q000150:complications*; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D000069285:Infliximab; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D012003:Rectal Fistula / Q000188:drug therapy* / Q000209:etiology / Q000601:surgery; D012007:Rectum / Q000601:surgery*; D016896:Treatment Outcome; D014945:Wound Healing
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007155:Immunologic Factors; D000069285:Infliximab; D000068879:Adalimumab