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.
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: Lioba F Courth; Maureen J Ostaff; Daniela Mailänder-Sánchez; Nisar P Malek; Eduard F Stange; Jan Wehkamp Journal: Proc Natl Acad Sci U S A Date: 2015-10-28 Impact factor: 11.205
Authors: Ling-Shiang Chuang; Nicole Villaverde; Ken Y Hui; Arthur Mortha; Adeeb Rahman; Adam P Levine; Talin Haritunians; Sok Meng Evelyn Ng; Wei Zhang; Nai-Yun Hsu; Jody-Ann Facey; Tramy Luong; Heriberto Fernandez-Hernandez; Dalin Li; Manuel Rivas; Elena R Schiff; Alexander Gusev; L Phillip Schumm; Beatrice M Bowen; Yashoda Sharma; Kaida Ning; Romain Remark; Sacha Gnjatic; Peter Legnani; James George; Bruce E Sands; Joanne M Stempak; Lisa W Datta; Seth Lipka; Seymour Katz; Adam S Cheifetz; Nir Barzilai; Nikolas Pontikos; Clara Abraham; Marla J Dubinsky; Stephan Targan; Kent Taylor; Jerome I Rotter; Ellen J Scherl; Robert J Desnick; Maria T Abreu; Hongyu Zhao; Gil Atzmon; Itsik Pe'er; Subra Kugathasan; Hakon Hakonarson; Jacob L McCauley; Todd Lencz; Ariel Darvasi; Vincent Plagnol; Mark S Silverberg; Aleixo M Muise; Steven R Brant; Mark J Daly; Anthony W Segal; Richard H Duerr; Miriam Merad; Dermot P B McGovern; Inga Peter; Judy H Cho Journal: Gastroenterology Date: 2016-07-01 Impact factor: 22.682