A randomised, double-blind, sham-controlled study of granulocyte/monocyte apheresis for moderate to severe Crohn's
Bruce E Sands1, Seymour Katz, Douglas C Wolf
1Division of Gastroenterology, Mount Sinai Medical Center and Mount Sinai School of Medicine, New York, NY 10029, USA. bruce.sands@mssm.edu
Insights
Granulocyte/monocyte apheresis (GMA) did not show significant benefits over sham procedures for Crohn's disease (CD) patients. This randomized trial found no difference in clinical remission or response rates between GMA and the control group.
Area of Science:
- Gastroenterology
- Immunology
- Medical Technology
Background:
- Activated granulocytes and monocytes are implicated in Crohn's disease (CD) pathogenesis.
- Previous small studies suggested granulocyte/monocyte apheresis (GMA) may benefit CD patients.
- A need exists to validate GMA efficacy in a rigorous clinical trial.
Purpose of the Study:
- To compare the efficacy of granulocyte/monocyte apheresis (GMA) against a sham procedure.
- To evaluate GMA's effectiveness in achieving clinical remission in moderate to severe Crohn's disease.
- To assess treatment outcomes in a randomized, double-blind study design.
Main Methods:
- A randomized, double-blind study comparing GMA with sham apheresis.
- Inclusion of patients with active Crohn's disease (CDAI 220-450).
- Ten apheresis sessions over 9 weeks, with efficacy assessed at week 12.
Main Results:
- No significant difference in clinical remission rates between GMA (17.8%) and sham (19.2%) groups.
- Similar clinical response rates observed in both GMA (28.0%) and sham (26.9%) groups.
- No significant differences in CDAI scores, quality of life, or endoscopic scores between groups.
Conclusions:
- Granulocyte/monocyte apheresis (GMA) was well-tolerated by patients.
- The study did not demonstrate GMA's superiority over sham procedures for Crohn's disease.
- Further research may be needed to explore potential roles or alternative applications of GMA.
Objectives:
Activated granulocytes and monocytes may contribute to the pathogenesis of Crohn's disease (CD). In small, uncontrolled studies, granulocyte/monocyte apheresis (GMA) has shown promise in treating CD. We conducted a randomised, double-blind study to compare GMA with a sham procedure in patients with moderate to severe CD.
Design:
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).
Results:
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.
Conclusions:
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 CD.
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