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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

Gastroenterology
|July 8, 2008
PubMed

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.
Abstract

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