title: Topical tacrolimus therapy for antibiotic-refractory pouchitis.
abstract: BACKGROUND
  Pouchitis is the most common complication after restorative proctocolectomy for ulcerative colitis, and it leads to pouch failure. The administration of oral antibiotics is the main treatment for pouchitis; however, in some cases, antibiotic-refractory pouchitis may develop, which requires further medical therapy.
  
  
  OBJECTIVE
  We investigated the applicability of topical tacrolimus for refractory pouchitis.
  
  
  METHODS
  We performed a prospective pilot study. The study protocols were registered with the University Hospital Medical Information Network Clinical Trials Registry, 000006658.
  
  
  METHODS
  This study was conducted in the Surgical Department of Hyogo College of Medicine.
  
  
  METHODS
  Patients with antibiotic-refractory pouchitis were treated for 8 weeks with a tacrolimus enema.
  
  
  METHODS
  The efficacy was assessed by comparing Pouchitis Disease Activity Index scores. Safety was assessed by measuring whole blood tacrolimus trough levels.
  
  
  RESULTS
  Ten patients with refractory pouchitis were enrolled. No severe adverse events occurred. The mean scores decreased from 15.9 ± 0.8 to 7.8 ± 0.8 during 8 weeks of treatment (p < 0.01). Specifically, the clinical symptom, endoscopic finding, and histological finding subscores decreased to 0.8 ± 0.6, 3.9 ± 0.2, and 2.9 ± 0.4. Nine patients recovered from their clinical symptoms, and 3 patients recovered from pouchitis.
  
  
  CONCLUSIONS
  This small study was neither blinded nor randomized.
  
  
  CONCLUSIONS
  This study demonstrates that the use of topical tacrolimus for the treatment of refractory pouchitis is safe and effective in the short term for clinical symptoms. Although complete endoscopic healing was not achieved, this treatment may have early rescue efficacy in the treatment of antibiotic-refractory pouchitis.
authors.affiliation: 1 Department of Lower Gastroenterological Surgery, Hyogo College of Medicine, Hyogo, Japan 2 Inflammatory Bowel Disease Center, Hyogo College of Medicine, Hyogo, Japan 3 Division of Lower Gastroenterology, Hyogo College of Medicine, Hyogo, Japan 4 Infection Control and Prevention, Hyogo College of Medicine, Hyogo, Japan.
authors.forename: Motoi
authors.initials: M
authors.lastname: Uchino
authors.forename: Hiroki
authors.initials: H
authors.lastname: Ikeuchi
authors.forename: Hiroki
authors.initials: H
authors.lastname: Matsuoka
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Bando
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Hida
authors.forename: Shiro
authors.initials: S
authors.lastname: Nakamura
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Takesue
authors.forename: Naohiro
authors.initials: N
authors.lastname: Tomita
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D002097:C-Reactive Protein / Q000378:metabolism; D003093:Colitis, Ulcerative / Q000601:surgery; D004733:Enema; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000097:blood; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D019449:Pouchitis / Q000188:drug therapy* / Q000473:pathology; D016737:Proctocolectomy, Restorative / Q000009:adverse effects; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects* / Q000097:blood; D017211:Treatment Failure
chemical_list: D000900:Anti-Bacterial Agents; D007166:Immunosuppressive Agents; D002097:C-Reactive Protein; D016559:Tacrolimus