title: Efficacy of granulocyte and monocyte apheresis for antibiotic-refractory pouchitis after proctocolectomy for ulcerative colitis: an open-label, prospective, multicentre study.
abstract: BACKGROUND
  Granulocyte and monocyte apheresis (GMA) has shown therapeutic efficacy in active ulcerative colitis (UC). We thought that in patients with pouchitis after proctocolectomy for UC, GMA might produce immunological effects in the intestinal mucosa, and improve clinical symptoms. This prospective study was to evaluate the efficacy of GMA for antibiotic-refractory pouchitis after proctocolectomy for UC.
  
  
  METHODS
  A total of 13 patients with pouchitis disease activity index (PDAI) > 7 unresponsive to 2 weeks of antibiotic therapy were included. All patients received 10 GMA sessions at 2 sessions/week over 5 consecutive weeks. The primary endpoints were response (a decrease of ⩾3 points in the PDAI) and remission (PDAI < 4). Secondary endpoints included reduction of white blood cells (WBCs), C-reactive protein (CRP), faecal markers (calprotectin and lactoferrin), reduction of the PDAI endoscopic subscore, and GMA safety.
  
  
  RESULTS
  The median PDAI score was significantly decreased from 11 (range, 9-15) at entry to 9 (range, 6-13) after the GMA therapy (p= 0.02). A total of six patients (46%) responded to the treatment, but none achieved remission. The median endoscopic subscore (maximum: 6) was 5 (range, 4-6) at entry and 5 (range, 1-6) after the treatment (p= 0.10). None of the laboratory markers (WBCs, CRP, faecal calprotectin and lactoferrin) significantly changed during the treatment. Transient adverse events (AEs) were observed in two patients (15%), dyspnoea in one and headache in one. The AEs were not serious, and all patients completed the 10 GMA sessions.
  
  
  CONCLUSIONS
  GMA has a good safety profile, but its efficacy appears to be limited in the management of chronic refractory pouchitis. However, a large controlled study should be conducted to evaluate the efficacy of GMA therapy in patients with pouchitis at an earlier clinical stage, before the disease has become refractory to conventional medical therapy.
authors.affiliation: Department of Surgery & Inflammatory Bowel Disease Centre, Yokkaichi Hazu Medical Centre, Yokkaichi, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yamamoto
authors.affiliation: Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Tanaka
authors.affiliation: Department of Surgery, Yokoyama Hospital for Gastroenterological Diseases (current affiliation: Yokoyama IBD Clinic), Nagoya, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Yokoyama
authors.affiliation: Department of Surgery & Inflammatory Bowel Disease Centre, Yokkaichi Hazu Medical Centre, Yokkaichi, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Shimoyama
authors.affiliation: Department of Inflammatory Bowel Disease Surgery, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Ikeuchi
authors.affiliation: Department of Inflammatory Bowel Disease Surgery, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: Motoi
authors.initials: M
authors.lastname: Uchino
authors.affiliation: Department of Surgical Oncology, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Watanabe
keywords: antibiotics; granulocyte and monocyte apheresis; pouchitis; proctocolectomy; ulcerative colitis