I was not familiar with the acronym “GRADE” which refers to an analysis by Cochrane review:

Grading of Recommendations Assessment, Development and Evaluation.

With regard to Sargramostim (GM-CSF), GRADE analysis indicates that GM-CSF does not appear more effective than placebo for Crohn’s disease (Inflamm Bowel Dis 2012; 18: 1333-39).

Three randomized studies were examined with 537 patients.  Clinical remission was achieved in 25.3% of GM-CSF patients compared with 17.5% of placebo-treated patients (p=0.17).  Clinical response (100-point CDAI score drop) was noted in 38.3% of GM-CSF group compared with 24.8% of placebo group (p=0.06).  Adverse effects were not statistically different either.

In my view, there are probably populations of IBD patients who will be benefit from GM-CSF.  The difficulty is identifying which groups.

Additional references:

• -Gastroenterology 2011; 141: 28, 208.  GM-CSF receptor (CD116) defective expression & function in 85% of IBD pts. n=52.
• -NEJM 2005; 352: 2193. Leukine decreased Crohn’s dz severity: 48% c decrease in CDAI of >100 (vs 26% placebo). injection & bone pain -common; 3 pts (n=81 in leukine group) c serious rxns- migraine, weakness/lethargy, R-sided weakness (?demyelinating d/o)
• -Lancet 2002; 360: 1478-1481. use of GM-CSF for Crohn’s.