title: Sargramostim (GM-CSF) for induction of remission in Crohn's disease: a cochrane inflammatory bowel disease and functional bowel disorders systematic review of randomized trials.
abstract: BACKGROUND
  We planned to systematically review the efficacy of sargramostim (granulocyte colony stimulating factor [GM-CSF]) for remission induction in patients with Crohn's disease (CD).
  
  
  METHODS
  A literature search to April 2011 was performed to identify all randomized trials studying sargramostim in patients with CD. The Cochrane risk of bias tool was used to evaluate study quality and the GRADE criteria were utilized to assess the overall quality of the evidence.
  
  
  RESULTS
  Three randomized studies (total 537 patients) were identified. The risk of bias was low for the three included studies. There was no statistically significant difference in the proportion of patients who achieved clinical remission (GM-CSF 25.3%; placebo 17.5%; relative risk [RR] 1.67; 95% confidence interval [CI] 0.80-3.50; P = 0.17), or 100-point clinical response (GM-CSF 38.3%; placebo 24.8%; RR 1.71 95% CI 0.98-2.97; P = 0.06). There was no statistically significant difference in the proportion of patients (GM-CSF 95.8%; placebo 89.3%) who experienced adverse events (RR 1.07; 95% CI 0.99-1.16; P = 0.08), or serious adverse events (GM-CSF 12.0% vs. placebo 4.8%; RR 2.21; 95% CI 0.84-5.81; P = 0.11).
  
  
  CONCLUSIONS
  Sargramostim does not appear to be more effective than placebo for induction of clinical remission or improvement in active CD. However, the GRADE analysis indicates that the overall quality of the evidence for the primary and secondary outcomes was low due to sparse data and heterogeneity, indicating that further research likely would have a significant impact on the effect estimates.
authors.affiliation: Faculty of Health Sciences, McMaster University, Hamilton, Canada.
authors.forename: Lee
authors.initials: L
authors.lastname: Roth
authors.forename: John K
authors.initials: JK
authors.lastname: MacDonald
authors.forename: John W D
authors.initials: JW
authors.lastname: McDonald
authors.forename: Nilesh
authors.initials: N
authors.lastname: Chande
mesh_terms: D003424:Crohn Disease / Q000188:drug therapy*; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000627:therapeutic use; D012074:Remission Induction
chemical_list: D007155:Immunologic Factors; D011994:Recombinant Proteins; C081222:sargramostim; D016178:Granulocyte-Macrophage Colony-Stimulating Factor