title: Infliximab in steroid-dependent ulcerative colitis: effectiveness and predictors of clinical and endoscopic remission.
abstract: BACKGROUND
  Up to 20% of patients with ulcerative colitis (UC) become steroid-dependent during their course. Thiopurines are recommended in steroid-dependent UC, but their efficacy is debated. Data exploring the use of infliximab in these patients are scarce. Aims of this study were to evaluate the effectiveness of infliximab in steroid-dependent UC and identify predictors of steroid-free remission, mucosal healing (MH), and colectomy.
  
  
  METHODS
  Steroid-dependent UC patients were enrolled and intentionally treated with infliximab. The prospectively designed analyses evaluated (1) steroid-free clinical remission at 6 and 12 months, (2) steroid-free clinical remission and MH at 12 months, and (3) colectomy within 12 months.
  
  
  RESULTS
  One hundred and twenty-six active steroid-dependent UC patients were studied. Of the 126 patients, 36 patients were retrospectively included and 90 patients prospectively enrolled. Steroid-free remission was 53% and 47% at 6 and 12 months, respectively. Predictors of steroid-free remission at 6 and 12 months were thiopurine-naive status (hazard ratio [HR], 2.5 and HR, 2.8, respectively) and combination therapy (HR, 2.1 and HR, 2.2, respectively). At 12 months, 32% were in steroid-free remission and MH. Thiopurine-naive status predicted steroid-free remission and MH (odds ratio, 3.6). C-reactive protein drop to normal after infliximab induction was predictive of steroid-free remission at 6 (HR, 5.9) and 12 months (HR, 4.6) and steroid-free remission and MH at 12 months (odds ratio, 6.0). Twelve patients underwent colectomy after a median of 4.7 months. Steroid sparing significantly reduced the risk of colectomy within 12 months (HR, 0.14).
  
  
  CONCLUSIONS
  Infliximab seems effective in steroid-dependent UC. Thiopurine-naive status and combination therapy significantly increase the rate of steroid-free remission up to 12 months.
authors: Internal Medicine and Gastroenterology Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy. alearmuzzi@yahoo.com
authors: Alessandro
authors: A
authors: Armuzzi
authors: Daniela
authors: D
authors: Pugliese
authors: Silvio
authors: S
authors: Danese
authors: Gianluca
authors: G
authors: Rizzo
authors: Carla
authors: C
authors: Felice
authors: Manuela
authors: M
authors: Marzo
authors: Gialuca
authors: G
authors: Andrisani
authors: Gionata
authors: G
authors: Fiorino
authors: Orsola
authors: O
authors: Sociale
authors: Alfredo
authors: A
authors: Papa
authors: Italo
authors: I
authors: De Vitis
authors: Gian Lodovico
authors: GL
authors: Rapaccini
authors: Luisa
authors: L
authors: Guidi
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000378:metabolism; D003082:Colectomy / Q000706:statistics & numerical data*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000601:surgery; D003131:Combined Modality Therapy; D004724:Endoscopy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D012074:Remission Induction; D012189:Retrospective Studies; D013256:Steroids / Q000008:administration & dosage*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D013256:Steroids; D002097:C-Reactive Protein; D000069285:Infliximab