Related Experiment Videos
A randomized, double-blind, sham-controlled study of granulocyte/monocyte apheresis for active ulcerative colitis
Bruce E Sands1, William J Sandborn, Brian Feagan
1MGH Crohn's & Colitis Center and Gastrointestinal Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA. bsands@partners.org
Insights
Granulocyte/monocyte apheresis was well tolerated for ulcerative colitis treatment but did not show significant improvement in clinical remission or response rates compared to sham treatment in this study.
Area of Science:
- Gastroenterology
- Immunology
- Medical Technology
Background:
- Activated granulocytes and monocytes/macrophages contribute to ulcerative colitis pathogenesis.
- Previous studies suggested granulocyte/monocyte apheresis (GMA) efficacy in ulcerative colitis.
Purpose of the Study:
- To evaluate the efficacy of GMA in a randomized, double-blind, sham-controlled trial for moderate-to-severe ulcerative colitis.
Main Methods:
- A randomized, double-blind, sham-controlled trial involving 168 patients in North America and 47 in Europe/Japan.
- Intervention involved GMA using the Adacolumn Apheresis System or sham apheresis over 9 weeks.
Main Results:
- Clinical remission rates were 17% for GMA and 11% for sham (P = .361).
- Clinical response rates were 44% for GMA and 39% for sham (P = .620).
- No significant differences were observed in endoscopic outcomes or quality-of-life scores between groups.
Conclusions:
- Granulocyte/monocyte apheresis was well tolerated in patients with moderate-to-severe ulcerative colitis.
- The study did not demonstrate GMA's efficacy for inducing clinical remission or response.
Background & Aims:
Activated granulocytes and monocytes/macrophages are implicated in the pathogenesis of ulcerative colitis. Open-label studies and clinical experience in Japan and Europe have suggested that granulocyte/monocyte apheresis is safe and effective in treating ulcerative colitis.
Methods:
We evaluated the efficacy of granulocyte/monocyte apheresis in a randomized, double-blind, sham-controlled trial in patients with active moderate-to-severe ulcerative colitis (Mayo score 6-11) in community-based and tertiary care centers. As intervention, we used granulocyte/monocyte apheresis with the Adacolumn Apheresis System (JIMRO, Ltd, Takasaki, Japan) or sham apheresis in a 2:1 ratio for 9 weeks of treatment in a North American pivotal study (N = 168) and in a smaller, companion study of identical design conducted in Europe and Japan (N = 47).
Results:
In the pivotal study, clinical remission rates (Mayo score 0-2, with scores of 0 on rectal bleeding and 0 or 1 on endoscopic examination) were 17% and 11% for the granulocyte/monocyte apheresis (n = 112)- and sham-treatment groups, respectively (n = 56; P = .361). Clinical response (Mayo score reduction of >/=3 points from baseline) was observed in 44% and 39% of patients, respectively (P = .620). Similar changes were observed for the apheresis- and sham-treatment groups for endoscopic remission and response, and changes in Mayo and quality-of-life scores. The companion study and pooled data from both studies also yielded similar results.
Conclusions:
In this study, granulocyte/monocyte apheresis was well tolerated but did not demonstrate efficacy for induction of clinical remission or response in patients with moderate-to-severe ulcerative colitis.
Related Concept Videos
Drugs for Treatment of Ulcerative Colitis in IBD
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids