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A randomized, double-blind, sham-controlled study of granulocyte/monocyte apheresis for active ulcerative colitis.

AbstractBACKGROUND & 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.
AuthorsBruce E Sands, William J Sandborn, Brian Feagan, Robert Löfberg, Toshifumi Hibi, Tao Wang, Lisa-Marie Gustofson, Cindy J Wong, Margaret K Vandervoort, Stephen Hanauer, Adacolumn Study Group
JournalGastroenterology (Gastroenterology) Vol. 135 Issue 2 Pg. 400-9 (Aug 2008) ISSN: 1528-0012 [Electronic] United States
PMID18602921 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Topics
  • Adult
  • Aged
  • Colitis, Ulcerative (pathology, therapy)
  • Colonoscopy
  • Double-Blind Method
  • Europe
  • Female
  • Granulocytes
  • Humans
  • Japan
  • Leukapheresis (methods)
  • Male
  • Middle Aged
  • Monocytes
  • North America
  • Prospective Studies
  • Quality of Life
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Treatment Outcome

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