title: Systematic review with meta-analysis: infliximab and immunosuppressant therapy vs. infliximab alone for active ulcerative colitis.
abstract: BACKGROUND
  The benefit of the combination of infliximab (IFX) and immunosuppressant (IS) therapy is debated in ulcerative colitis (UC).
  
  
  OBJECTIVE
  To determine whether the combination of IFX and IS therapy is more effective than infliximab alone for active UC regardless of prior IS use.
  
  
  METHODS
  We identified all controlled trials including patients with moderate-to-severe active UC, treated by either IFX or combined IFX-IS therapy. The main outcome was clinical remission at 4-6 months. Two statistical methods were used, Mantel-Haenszel and Der-Simonian and Laird. Inter-trial heterogeneity was taken into account and publication bias was assessed.
  
  
  RESULTS
  Four controlled trials were analysed and included in the meta-analysis. These four trials included 765 patients, 389 treated with IFX alone and 376 treated with IFX and IS. At 4-6 months' therapy, the clinical remission rate was significantly lower for the IFX monotherapy group OR 0.50, 95% CI [0.34-0.73], P < 0.01 (P-heterogeneity = 0.49). The Harbord test did not show evidence of publication bias (P = 0.29). Calculation of an adjusted OR using the Duval and Tweedie method did not significantly modify results [OR 0.63, 95% CI (0.47-0.85)]. According to Orwin's formula, four additional medium-sized nonsignificant studies would be necessary to reduce the effect size to a nonsignificant value. At 12 months of therapy, there was no significant difference between the two groups: OR 0.60, 95% CI [0.17-2.06], P = 0.41 (P-heterogeneity = 0.01).
  
  
  CONCLUSIONS
  Combination therapy with IFX-IS is more effective than IFX alone for achieving and maintaining clinical remission at 4-6 months for patients with moderate-to-severe ulcerative colitis, regardless of prior IS use.
authors: Service d'Hépato-gastroentérologie, Hôpital Saint Eloi, Centre Hospitalo-Universitaire de Montpellier, Montpellier, France.
authors: D
authors: D
authors: Christophorou
authors: N
authors: N
authors: Funakoshi
authors: Y
authors: Y
authors: Duny
authors: J-C
authors: JC
authors: Valats
authors: M
authors: M
authors: Bismuth
authors: G
authors: G
authors: Pineton De Chambrun
authors: J-P
authors: JP
authors: Daures
authors: P
authors: P
authors: Blanc
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000069285:Infliximab; D008875:Middle Aged; D013997:Time Factors
chemical_list: D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D000069285:Infliximab