title: Open label trial of granulocyte apheresis suggests therapeutic efficacy in chronically active steroid refractory ulcerative colitis.
abstract: OBJECTIVE
  To study the efficacy, safety, and feasibility of a granulocyte adsorptive type apheresis system for the treatment of patients with chronically active ulcerative colitis despite standard therapy.
  
  
  METHODS
  An open label multicenter study was carried out in 39 patients with active ulcerative colitis (CAI 6-8) despite continuous use of steroids (a minimum total dose of 400 mg prednisone within the last 4 wk). Patients received a total of five aphereses using a granulocyte adsorptive technique (Adacolumn (reg), Otsuka Pharmaceutical Europe, UK). Assessments at wk 6 and during follow-up until 4 mo comprised clinical (CAI) and endoscopic (EI) activity index, histology, quality of life (IBDQ), and laboratory tests.
  
  
  RESULTS
  Thirty-five out of thirty-nine patients were qualified for intent-to-treat analysis. After the apheresis treatment at wk 6, 13/35 (37.1%) patients achieved clinical remission and 10/35 (28.6%) patients had endoscopic remission (CAI<4, EI<4). Quality of life (IBDQ) increased significantly (24 points, P<0.01) at wk 6. Apheresis could be performed in all but one patient. Aphereses were well tolerated, only one patient experienced anemia.
  
  
  CONCLUSIONS
  In patients with steroid refractory ulcerative colitis, five aphereses with a granulocyte/monocyte depleting filter show potential short-term efficacy. Tolerability and technical feasibility of the procedure are excellent.
authors.affiliation: Evangelisches Krankenhaus Kalk, Innere Abteilung, Universität zu Köln, Germany. ansorg@evkk.de
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Kruis
authors.forename: Axel
authors.initials: A
authors.lastname: Dignass
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Steinhagen-Thiessen
authors.forename: Julia
authors.initials: J
authors.lastname: Morgenstern
authors.forename: Joachim
authors.initials: J
authors.lastname: Mössner
authors.forename: Stephan
authors.initials: S
authors.lastname: Schreiber
authors.forename: Maurizio
authors.initials: M
authors.lastname: Vecchi
authors.forename: Alberto
authors.initials: A
authors.lastname: Malesci
authors.forename: Max
authors.initials: M
authors.lastname: Reinshagen
authors.forename: Robert
authors.initials: R
authors.lastname: Löfberg
mesh_terms: D000328:Adult; D000368:Aged; D001781:Blood Component Removal / Q000379:methods*; D002097:C-Reactive Protein / Q000276:immunology; D003093:Colitis, Ulcerative / Q000276:immunology / Q000628:therapy; D005260:Female; D006098:Granulocytes / Q000276:immunology*; D006801:Humans; D008875:Middle Aged; D009000:Monocytes / Q000276:immunology; D015337:Multicenter Studies as Topic; D009504:Neutrophils / Q000276:immunology; D011446:Prospective Studies; D012074:Remission Induction; D013256:Steroids / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D013256:Steroids; D002097:C-Reactive Protein