title: Open-label infliximab therapy in ulcerative colitis: a multicenter survey of results and predictors of response.
abstract: OBJECTIVE
  Results of randomized controlled trials showing efficacy of infliximab in ulcerative colitis (UC) should be confirmed in clinical practice. We aimed to evaluate the efficacy and safety of infliximab in UC patients of the Madrid area, looking for clinical predictors of response.
  
  
  METHODS
  Multicenter retrospective survey of all UC patients treated with infliximab in the region of Madrid (Spain).
  
  
  RESULTS
  47 UC patients were included (45% males, mean age 44 +/- 15 yrs), mean follow up of 4.7 months (range 0.5-21), and a total number of 211 infliximab infusions. Clinical response and steroid-free remission rates were, respectively, 97/42% in the 2nd week, 93/69% in the 6th week, and 80/65% at the long-term follow up (mean 8.2 months, range 3.5-21). Colectomy rate was 10.6% (five patients). Age, gender, disease duration, indication (steroid-resistance/dependence), disease severity, C-reactive protein, concomitant thiopurinic therapy or smoking habit did not influence on efficacy. Extent of the disease was the only predictive factor (p=0.02). Only 4 cases of mild adverse events were reported.
  
  
  CONCLUSIONS
  Infliximab is effective and safe for UC. Real life clinical practice may have better outcome than showed in randomized controlled trials. Extent of the disease was the only predictive factor for clinical response in our experience.
authors.affiliation: Digestive Department of La Princesa Universitary Hospital, Madrid, Spain.
authors.forename: Yago
authors.initials: Y
authors.lastname: Gonzalez-Lama
authors.forename: Ignacio
authors.initials: I
authors.lastname: Fernandez-Blanco
authors.forename: Antonio
authors.initials: A
authors.lastname: Lopez-SanRoman
authors.forename: Carlos
authors.initials: C
authors.lastname: Taxonera
authors.forename: Begoña
authors.initials: B
authors.lastname: Casis
authors.forename: Susana
authors.initials: S
authors.lastname: Tabernero
authors.forename: Fernando
authors.initials: F
authors.lastname: Bermejo
authors.forename: Francisca
authors.initials: F
authors.lastname: Martinez-Silva
authors.forename: Juan Luis
authors.initials: JL
authors.lastname: Mendoza
authors.forename: Pilar
authors.initials: P
authors.lastname: Martinez-Montiel
authors.forename: Jose Antonio
authors.initials: JA
authors.lastname: Carneros
authors.forename: Fernando
authors.initials: F
authors.lastname: Sanchez
authors.forename: Jose
authors.initials: J
authors.lastname: Maté
authors.forename: Javier P
authors.initials: JP
authors.lastname: Gisbert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab