A randomised, double-blind, sham-controlled study of granulocyte/monocyte apheresis for moderate to severe Crohns disease
Sands BE et al. – Granulocyte/monocyte apheresis (GMA) was well tolerated, but this study did not demonstrate its effectiveness over a sham procedure in inducing clinical remission or response in patients with moderate to severe Crohn's disease (CD).Methods
- Patients with active CD as defined by a Crohn's Disease Activity Index (CDAI) of 220-450 were randomly allocated in a 2:1 ratio to treatment with GMA using the Adacolumn Apheresis System (JIMRO, Takasaki, Japan) or sham apheresis.
- Ten apheresis sessions were scheduled over a 9-week period, and efficacy was evaluated at week 12.
- The primary end point was the proportion of patients achieving clinical remission (CDAI score ≥150 without use of prohibited drugs).
- Clinical remission was achieved by 17.8% of patients in the GMA group (n=157) compared with 19.2% of those in the sham control group (n=78) (absolute difference -1.4% (95% CI-12.8% to 8.5%), p=0.858).
- Clinical response (defined as a ≥100-point decrease in CDAI) was achieved by 28.0% and 26.9% of patients in the GMA and sham groups, respectively (p=1.000).
- The two treatments produced similar changes from baseline in CDAI and quality of life, as well as in disease severity assessed endoscopically.
- The incidence and types of adverse events did not differ between groups.