title: Mucosal healing with oral tacrolimus is associated with favorable medium- and long-term prognosis in steroid-refractory/dependent ulcerative colitis patients.
abstract: BACKGROUND
  Oral administration of tacrolimus is an effective remission induction therapy for steroid-refractory/dependent ulcerative colitis (UC).
  
  
  OBJECTIVE
  This study aimed to evaluate the short- as well as medium- and long-term effectiveness of tacrolimus therapy.
  
  
  METHODS
  The medical records of 51 patients treated with tacrolimus for UC at our hospital between July 2009 and December 2011 were reviewed retrospectively. Clinical remission and improvement were defined as a Lichtiger score of 4 or less and as a Lichtiger score of ≤10 and a reduction in the score of ≥3 compared with the baseline score, respectively. Endoscopic findings were evaluated based on the endoscopic activity index and Mayo endoscopic score.
  
  
  RESULTS
  The clinical effectiveness combining clinical remission and improvement was observed in 62.7% of the patients at 3 months. Thirty-six patients underwent colonoscopy at 3 months, and 12 (33.3%) and 10 patients (27.8%) showed Mayo endoscopic scores of 0 and 1, respectively. On Kaplan-Meier analysis, the overall percentage of event-free survivors, who did not require colectomy nor switching to other induction therapy such as infliximab, was 73.0% at 6 months, 49.9% at 1 year, and 37.8% at 2 years. Patients with a Mayo endoscopic score of 0-1 at 3 months showed significantly better medium- and long-term prognosis than those with a score of 2-3 (p<0.01). All adverse events, including infections in 2 patients, were reversible.
  
  
  CONCLUSIONS
  Tacrolimus therapy was effective for inducing clinical and endoscopic remission of steroid-refractory/dependent UC. Endoscopic improvement was associated with favorable medium- and long-term prognosis.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan; Department of Gastroenterology and Hepatology, Tokyo Dental College, Ichikawa General Hospital, Chiba, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Miyoshi
authors.forename: Katsuyoshi
authors.initials: K
authors.lastname: Matsuoka
authors.forename: Nagamu
authors.initials: N
authors.lastname: Inoue
authors.forename: Tadakazu
authors.initials: T
authors.lastname: Hisamatsu
authors.forename: Riko
authors.initials: R
authors.lastname: Ichikawa
authors.forename: Tomoharu
authors.initials: T
authors.lastname: Yajima
authors.forename: Susumu
authors.initials: S
authors.lastname: Okamoto
authors.forename: Makoto
authors.initials: M
authors.lastname: Naganuma
authors.forename: Toshiro
authors.initials: T
authors.lastname: Sato
authors.forename: Takanori
authors.initials: T
authors.lastname: Kanai
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Ogata
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Iwao
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D003113:Colonoscopy; D018572:Disease-Free Survival; D004351:Drug Resistance; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007413:Intestinal Mucosa / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013256:Steroids / Q000627:therapeutic use; D016559:Tacrolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors; D014945:Wound Healing; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D007166:Immunosuppressive Agents; D013256:Steroids; D016559:Tacrolimus
keywords: Mucosal healing; Tacrolimus; Ulcerative colitis