title: Infliximab in the treatment of Crohn's disease: predictors of response in an Italian multicentric open study.
abstract: BACKGROUND
  Almost 20% of patients with active Crohn's disease are refractory to conventional therapy. Infliximab is a treatment of proven efficacy in this group of patients and it is not clear which variables predict a good response. AIMS.: To evaluate the role of infliximab looking at the predictors of response in a large series of patients with Crohn's disease.
  
  
  METHODS
  Five hundred and seventy-three patients with luminal refractory Crohn's disease (Crohn's Disease Activity Index (CDAI)>220-400) (312 patients) or with fistulising disease (190 patients) or both of them (71 patients) were treated with a dose of 5 mg/kg in 12 Italian referral centres. The primary endpoints of the study were clinical response and clinical remission for luminal refractory and fistulising disease. We evaluated at univariable and multivariable analysis the following variables: number of infusions, sex, age at diagnosis, smoking habit, site of disease, previous surgery, extraintestinal manifestations and concomitant therapies, and type of fistulas.
  
  
  RESULTS
  Patients with luminal refractory disease: 322 patients (84.1%) had a clinical response and 228 (59.5%) reached clinical remission. Patients with fistulising disease: 187 patients (72%) had a reduction of 50% of the number of fistulas and in 107 (41%) a total closure of fistulas was observed. For luminal disease, single infusion (OR 0.49, 95% CI 0.28-0.86) and previous surgery (OR 0.53, 95% CI 0.30-0.93) predicted a worse response for fistulising disease. Other fistulas responded worse than perianal fistulas (OR 0.57, 95% CI 0.303-1.097).
  
  
  CONCLUSIONS
  In Crohn's disease infliximab is effective in luminal refractory and in fistulising disease. A single infusion and previous surgery predicted a worse response in luminal disease whereas perianal fistulas predicted a better response than other type of fistulas.
authors.affiliation: Department of Internal Medicine, 'V. Cervello' Hospital, Via Trabucco 180, Palermo 90146, Italy. ambrogiorlando@tiscalinet.it
authors.forename: A
authors.initials: A
authors.lastname: Orlando
authors.forename: E
authors.initials: E
authors.lastname: Colombo
authors.forename: A
authors.initials: A
authors.lastname: Kohn
authors.forename: L
authors.initials: L
authors.lastname: Biancone
authors.forename: F
authors.initials: F
authors.lastname: Rizzello
authors.forename: A
authors.initials: A
authors.lastname: Viscido
authors.forename: R
authors.initials: R
authors.lastname: Sostegni
authors.forename: L
authors.initials: L
authors.lastname: Benazzato
authors.forename: F
authors.initials: F
authors.lastname: Castiglione
authors.forename: C
authors.initials: C
authors.lastname: Papi
authors.forename: G
authors.initials: G
authors.lastname: Meucci
authors.forename: G
authors.initials: G
authors.lastname: Riegler
authors.forename: F
authors.initials: F
authors.lastname: Mocciaro
authors.forename: A
authors.initials: A
authors.lastname: Cassinotti
authors.forename: R
authors.initials: R
authors.lastname: Cosintino
authors.forename: A
authors.initials: A
authors.lastname: Geremia
authors.forename: C
authors.initials: C
authors.lastname: Morselli
authors.forename: E
authors.initials: E
authors.lastname: Angelucci
authors.forename: A
authors.initials: A
authors.lastname: Lavagna
authors.forename: A
authors.initials: A
authors.lastname: Rispo
authors.forename: F
authors.initials: F
authors.lastname: Bossa
authors.forename: D
authors.initials: D
authors.lastname: Scimeca
authors.forename: M
authors.initials: M
authors.lastname: Cottone
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy* / Q000601:surgery; D004305:Dose-Response Relationship, Drug; D005260:Female; D005402:Fistula / Q000188:drug therapy; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab; D007558:Italy; D008297:Male; D015999:Multivariate Analysis; D012074:Remission Induction; D012907:Smoking / Q000009:adverse effects
chemical_list: D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab