title: Infliximab salvage therapy after failure of ciclosporin in corticosteroid-refractory ulcerative colitis: a multicentre study.
abstract: BACKGROUND
  Ciclosporin has proven to be effective in patients with corticosteroid-refractory ulcerative colitis (UC). When therapy with this drug fails, infliximab can be considered to avoid colectomy. The efficacy and safety of this sequential approach remain unknown.
  
  
  OBJECTIVE
  To assess the efficacy and safety profile of treatment with infliximab after failure of ciclosporin in patients with a corticosteroid-refractory flare of UC.
  
  
  METHODS
  Retrospective review of medical records of patients with a corticosteroid-refractory flare of UC who did not respond to ciclosporin and received salvage therapy with infliximab within a month of discontinuing ciclosporin. The severity of the flare and response to the treatment were graded using the Lichtiger index. Cumulative rates of colectomy were calculated using Kaplan-Meier analysis. Cox regression analysis was performed to identify predictors of colectomy. To evaluate the safety profile of this treatment strategy, any adverse event occurring after the first infusion of infliximab was considered.
  
  
  RESULTS
  The study population comprised 47 patients with corticosteroid-refractory UC treated with infliximab after failure of ciclosporin. The median baseline Lichtiger index was 13. The mean time from the last ciclosporin dose to the first infliximab infusion was 6 days. After the first infliximab infusion, 13% of patients achieved remission, and 74% partial response. Of the 35 patients who received the third infliximab infusion, 60% achieved remission, and 37% partial response. Fourteen patients (30%) underwent colectomy. The rate of adverse events was 23%. One death occurred in a 40-year-old man who failed ciclosporin and infliximab and underwent surgery 10 days after the first infliximab infusion; he died of nosocomial pneumonia.
  
  
  CONCLUSIONS
  Treatment with infliximab makes it possible to avoid colectomy in two-thirds of corticosteroid-refractory UC patients in whom ciclosporin fails. However, the rates of adverse events and mortality mean that the decision to administer sequential therapy (ciclosporin-infliximab) should be taken on an individual basis.
authors.affiliation: Gastroenterology Department, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa, Madrid, Spain. mariachs2005@gmail.com
authors.forename: M
authors.initials: M
authors.lastname: Chaparro
authors.forename: P
authors.initials: P
authors.lastname: Burgueño
authors.forename: E
authors.initials: E
authors.lastname: Iglesias
authors.forename: J
authors.initials: J
authors.lastname: Panés
authors.forename: F
authors.initials: F
authors.lastname: Muñoz
authors.forename: G
authors.initials: G
authors.lastname: Bastida
authors.forename: L
authors.initials: L
authors.lastname: Castro
authors.forename: C
authors.initials: C
authors.lastname: Jiménez
authors.forename: J L
authors.initials: JL
authors.lastname: Mendoza
authors.forename: M
authors.initials: M
authors.lastname: Barreiro-de Acosta
authors.forename: S Gómez
authors.initials: SG
authors.lastname: Senent
authors.forename: F
authors.initials: F
authors.lastname: Gomollón
authors.forename: X
authors.initials: X
authors.lastname: Calvet
authors.forename: E
authors.initials: E
authors.lastname: García-Planella
authors.forename: M
authors.initials: M
authors.lastname: Gómez
authors.forename: V
authors.initials: V
authors.lastname: Hernández
authors.forename: J
authors.initials: J
authors.lastname: Hinojosa
authors.forename: M
authors.initials: M
authors.lastname: Mañosa
authors.forename: O Pérez
authors.initials: OP
authors.lastname: Nyssen
authors.forename: J P
authors.initials: JP
authors.lastname: Gisbert
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D016572:Cyclosporine / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D016879:Salvage Therapy; D012720:Severity of Illness Index; D013030:Spain; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D000069285:Infliximab