title: A randomized, double-blind, sham-controlled study of granulocyte/monocyte apheresis for active ulcerative colitis.
abstract: OBJECTIVE
  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.
authors.affiliation: MGH Crohn's & Colitis Center and Gastrointestinal Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA. bsands@partners.org
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Sands
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Brian
authors.initials: B
authors.lastname: Feagan
authors.forename: Robert
authors.initials: R
authors.lastname: Löfberg
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
authors.forename: Tao
authors.initials: T
authors.lastname: Wang
authors.forename: Lisa-Marie
authors.initials: LM
authors.lastname: Gustofson
authors.forename: Cindy J
authors.initials: CJ
authors.lastname: Wong
authors.forename: Margaret K
authors.initials: MK
authors.lastname: Vandervoort
authors.forename: Stephen
authors.initials: S
authors.lastname: Hanauer
mesh_terms: D000328:Adult; D000368:Aged; D003093:Colitis, Ulcerative / Q000473:pathology / Q000628:therapy*; D003113:Colonoscopy; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006098:Granulocytes; D006801:Humans; D007564:Japan; D007937:Leukapheresis / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009000:Monocytes; D009656:North America; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome