title: Evaluation of 5 versus 10 granulocyteaphaeresis sessions in steroid-dependent ulcerative colitis: a pilot, prospective, multicenter, randomized study.
abstract: OBJECTIVE
  To evaluate the efficacy of 5 compared to 10 granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis.
  
  
  METHODS
  In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption.
  
  
  RESULTS
  Nine patients were randomized to 5 granulocyteaphaeresis sessions (group 1) and 11 patients to 10 granulocyteaphaeresis sessions (group 2). At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases. Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year follow-up. One serious adverse event, not related to the study therapy, was reported.
  
  
  CONCLUSIONS
  Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect.
authors.affiliation: Gastroenterology Department, Hospital Clinic de Barcelona, C/Villarroel 170, 08036-Barcelona, Spain. ericart@clinic.ub.es
authors.forename: Elena
authors.initials: E
authors.lastname: Ricart
authors.forename: Maria
authors.initials: M
authors.lastname: Esteve
authors.forename: Montserrat
authors.initials: M
authors.lastname: Andreu
authors.forename: Francesc
authors.initials: F
authors.lastname: Casellas
authors.forename: David
authors.initials: D
authors.lastname: Monfort
authors.forename: Miquel
authors.initials: M
authors.lastname: Sans
authors.forename: Natalia
authors.initials: N
authors.lastname: Oudovenko
authors.forename: Raul
authors.initials: R
authors.lastname: Lafuente
authors.forename: Julian
authors.initials: J
authors.lastname: Panes
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003093:Colitis, Ulcerative / Q000473:pathology / Q000628:therapy*; D023381:Endpoint Determination; D005260:Female; D006098:Granulocytes / Q000473:pathology*; D006801:Humans; D007937:Leukapheresis / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012074:Remission Induction / Q000379:methods; D013256:Steroids / Q000627:therapeutic use
chemical_list: D013256:Steroids