title: Adsorptive granulocyte/monocyte apheresis for the maintenance of remission in patients with ulcerative colitis: a prospective randomized, double blind, sham-controlled clinical trial.
abstract: OBJECTIVE
  Weekly granulocyte/monocyte adsorption (GMA) to deplete elevated and activated leucocytes should serve as a non-pharmacological intervention to induce remission in patients with ulcerative colitis (UC). This trial assessed the efficacy of monthly GMA as a maintenance therapy to suppress UC relapse.
  
  
  METHODS
  Thirty-three corticosteroid refractory patients with active UC received 10 weekly GMA sessions as a remission induction therapy. They were then randomized to receive one GMA session every 4 weeks (True, n=11), extracorporeal circulation without the GMA column every 4 weeks (Sham, n=11), or no additional intervention (Control, n=11). The primary endpoint was the rate of avoiding relapse (AR) over 48 weeks.
  
  
  RESULTS
  At week 48, the AR rates in the True, Sham, and Control groups were 40.0%, 9.1%, and 18.2%, respectively. All patients were steroid-free, but no statistically significant difference was seen among the three arms. However, in patients who could taper their prednisolone dose to <20 mg/day during the remission induction therapy, the AR in the True group was better than in the Sham (p<0.03) or Control (p<0.05) groups.
  
  
  CONCLUSIONS
  Monthly GMA may potentially prevent UC relapse in patients who have achieved remission through weekly GMA, especially in patients on <20 mg/day PSL at the start of the maintenance therapy.
authors.affiliation: Division of Lower Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Fukunaga
authors.forename: Yoko
authors.initials: Y
authors.lastname: Yokoyama
authors.forename: Koji
authors.initials: K
authors.lastname: Kamokozuru
authors.forename: Kazuko
authors.initials: K
authors.lastname: Nagase
authors.forename: Shiro
authors.initials: S
authors.lastname: Nakamura
authors.forename: Hiroto
authors.initials: H
authors.lastname: Miwa
authors.forename: Takayuki
authors.initials: T
authors.lastname: Matsumoto