title: Pilot feasibility studies of leukocytapheresis with the Adacolumn Apheresis System in patients with active ulcerative colitis or Crohn disease.
abstract: OBJECTIVE
  Two uncontrolled, multicenter feasibility studies evaluated safety and pilot efficacy of selective granulocyte and monocyte adsorption apheresis (GMA) with the Adacolumn Apheresis System for treatment of moderate-to-severe ulcerative colitis (UC) and Crohn disease (CD) patients refractory/intolerant to conventional pharmacologic therapy.
  
  
  BACKGROUND
  Patients with UC and CD, characterized by elevations in peripheral blood granulocytes, monocytes/macrophages, and proinflammatory mediators, may benefit from reductions in activated granulocytes and monocytes by selective apheresis.
  
  
  METHODS
  Patients underwent weekly Adacolumn sessions for 5 weeks. Pilot efficacy assessments used disease activity index (DAI) for UC (0-12) or CD activity index (CDAI; 0-600) for CD.
  
  
  RESULTS
  Eleven of 15 UC patients completed all 5 treatments. Mean DAI scores fell from 8.4+/-1.3 (baseline) to 5.2+/-2.9 (week 7). Five patients had DAI reductions of > or = 3 points at week 7. Fourteen of 15 CD patients completed all 5 treatments. Mean CDAI scores fell from 308.0+/-76.5 (baseline) to 200.6+/-117.4 (week 7). Nine CD patients responded (CDAI reductions > or = 70 points) at week 7. Remission (CDAI score < or = 150 at week 7) was observed in 6 patients. There were no device-related serious adverse effects.
  
  
  CONCLUSIONS
  Treatment with Adacolumn may be feasible and effective in patients with moderate-to-severe refractory inflammatory bowel disease. Larger sham-controlled studies are ongoing.
authors.affiliation: Gastrointestinal Unit and MGH Crohn's and Colitis Center, Massachusetts General Hospital, Boston, MA 02114, 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: Douglas C
authors.initials: DC
authors.lastname: Wolf
authors.forename: Seymour
authors.initials: S
authors.lastname: Katz
authors.forename: Michael
authors.initials: M
authors.lastname: Safdi
authors.forename: David A
authors.initials: DA
authors.lastname: Schwartz
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Hanauer
mesh_terms: D000293:Adolescent; D000327:Adsorption; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000494:pharmacology; D003093:Colitis, Ulcerative / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D003424:Crohn Disease / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D004351:Drug Resistance / Q000187:drug effects; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D007937:Leukapheresis / Q000295:instrumentation* / Q000379:methods; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D007166:Immunosuppressive Agents