title: Open-label infliximab therapy in Crohn's disease: a long-term multicenter study of efficacy, safety and predictors of response.
abstract: BACKGROUND
  Efficacy of infliximab in Crohn's disease (CD) showed by randomized controlled trials must be confirmed in clinical practice. We aimed to evaluate efficacy and safety of infliximab in CD patients of the Madrid area, looking for clinical predictors of response.
  
  
  METHODS
  Multicenter retrospective survey of all CD patients treated with infliximab in 8 University hospitals of the Madrid area (Spain) with a minimum follow up of 14 wks.
  
  
  RESULTS
  169 patients included (48%males, mean age 39 +/- 12 yrs). 64% of them had perianal disease. 82% were under immunosuppressants. 1,355 infliximab infusions administered (mean 8, range 1-30). 90% response rate and 48% remission rate were obtained with induction therapy. 73% followed maintenance treatment, and 78% of them maintained or improved the response after a mean follow up of 28 months (range 3.5-86). 24 patients lost response during the follow up, after a mean of 41 wks (range 6-248). Only the prescription of maintenance therapy was predictive factor for favourable response (p < 0.01). 17 infusion reactions were reported (10% of the patients, 1.2% of the infusions; only one case was severe) and were the cause of treatment withdrawal in 7 patients. Co-treatment with immunosuppressive drugs and maintenance infliximab therapy were protective factors for infusion reactions (p < 0.05). Other adverse events occurred in 26% of the patients, and were cause of treatment withdrawal in 7 patients.
  
  
  CONCLUSIONS
  Infliximab is effective and safe for CD management but concomitant immunosuppressive drugs and maintenance treatment should be prescribed to obtain the best outcome. That confirms in a real life clinical setting the favourable results obtained in randomized clinical trials.
authors.affiliation: La Princesa University Hospital (Universidad Autónoma) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd II).
authors.forename: Yago
authors.initials: Y
authors.lastname: González-Lama
authors.forename: Antonio
authors.initials: A
authors.lastname: López-San Román
authors.forename: Ignacio
authors.initials: I
authors.lastname: Marín-Jiménez
authors.forename: Begoña
authors.initials: B
authors.lastname: Casis
authors.forename: Isabel
authors.initials: I
authors.lastname: Vera
authors.forename: Fernando
authors.initials: F
authors.lastname: Bermejo
authors.forename: José Lázaro
authors.initials: JL
authors.lastname: Pérez-Calle
authors.forename: Carlos
authors.initials: C
authors.lastname: Taxonera
authors.forename: Francisca
authors.initials: F
authors.lastname: Martínez-Silva
authors.forename: Luis
authors.initials: L
authors.lastname: Menchén
authors.forename: Pilar
authors.initials: P
authors.lastname: Martínez-Montiel
authors.forename: Marta
authors.initials: M
authors.lastname: Calvo
authors.forename: José Antonio
authors.initials: JA
authors.lastname: Carneros
authors.forename: Pilar
authors.initials: P
authors.lastname: López
authors.forename: Juan Luis
authors.initials: JL
authors.lastname: Mendoza
authors.forename: José María
authors.initials: JM
authors.lastname: Milicua
authors.forename: Alaín
authors.initials: A
authors.lastname: Huerta
authors.forename: Fernando
authors.initials: F
authors.lastname: Sánchez
authors.forename: Luis
authors.initials: L
authors.lastname: Abreu
authors.forename: Natalia
authors.initials: N
authors.lastname: López-Palacios
authors.forename: José
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; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013997:Time Factors; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab