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Topical tacrolimus therapy for antibiotic-refractory pouchitis.

AbstractBACKGROUND:
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.
DESIGN:
We performed a prospective pilot study. The study protocols were registered with the University Hospital Medical Information Network Clinical Trials Registry, 000006658.
SETTING:
This study was conducted in the Surgical Department of Hyogo College of Medicine.
PATIENTS:
Patients with antibiotic-refractory pouchitis were treated for 8 weeks with a tacrolimus enema.
MAIN OUTCOME MEASURES:
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.
LIMITATIONS:
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.
AuthorsMotoi Uchino, Hiroki Ikeuchi, Hiroki Matsuoka, Toshihiro Bando, Nobuyuki Hida, Shiro Nakamura, Yoshio Takesue, Naohiro Tomita
JournalDiseases of the colon and rectum (Dis Colon Rectum) Vol. 56 Issue 10 Pg. 1166-73 (Oct 2013) ISSN: 1530-0358 [Electronic] United States
PMID24022534 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Bacterial Agents
  • Immunosuppressive Agents
  • C-Reactive Protein
  • Tacrolimus
Topics
  • Administration, Topical
  • Adult
  • Anti-Bacterial Agents (therapeutic use)
  • C-Reactive Protein (metabolism)
  • Colitis, Ulcerative (surgery)
  • Enema
  • Female
  • Humans
  • Immunosuppressive Agents (administration & dosage, adverse effects, blood)
  • Male
  • Middle Aged
  • Pilot Projects
  • Pouchitis (drug therapy, pathology)
  • Proctocolectomy, Restorative (adverse effects)
  • Severity of Illness Index
  • Tacrolimus (administration & dosage, adverse effects, blood)
  • Treatment Failure

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