title: Tacrolimus induction followed by maintenance monotherapy is useful in selected patients with moderate-to-severe ulcerative colitis refractory to prior treatment.
abstract: BACKGROUND
  Tacrolimus in refractory ulcerative colitis often serves as a bridge to long-term maintenance therapy with thiopurines. Our aim was to review efficacy and safety of tacrolimus in active ulcerative colitis resistant to conventional therapies, including anti-tumour necrosis factor.
  
  
  METHODS
  Charts of consecutive outpatients with refractory ulcerative colitis, in whom tacrolimus was orally administered as a 12 week-induction (target trough levels 10-15ng/mL) followed by a maintenance therapy (target trough levels 5-10ng/mL), were retrospectively reviewed. Clinical remission and response at weeks 4, 12 and 52 as well as adverse events within 1-year therapy were reported.
  
  
  RESULTS
  Twelve (40%) and six (20%) of the 30 patients included (14 males, mean age 37.1±1.4 years) achieved a clinical remission and response, respectively, at week 12. Three responders to tacrolimus initiation experienced drug-related adverse events requiring discontinuation. Among the 18 remaining initial responders who tolerated tacrolimus, 8 (27%) were in clinical remission at week 52, whereas the remainder either experienced adverse events requiring drug withdrawal (n=4) or relapsed (n=6). Overall adverse events were recorded in 14 patients (46%), mainly finger tremor and urinary infections.
  
  
  CONCLUSIONS
  Oral monotherapy with tacrolimus may be a valuable long-term therapeutic option in selected patients with moderate-to-severe active refractory ulcerative colitis.
authors.affiliation: INSERM U-1111 CIRI (International Center for Infectiology Research) and University Claude Bernard Lyon 1, Lyon, France; Hospices Civils de Lyon, Department of Gastroenterology, Lyon-Sud Hospital, Pierre-Bénite, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Boschetti
authors.affiliation: INSERM U-1111 CIRI (International Center for Infectiology Research) and University Claude Bernard Lyon 1, Lyon, France; Hospices Civils de Lyon, Department of Gastroenterology, Lyon-Sud Hospital, Pierre-Bénite, France. Electronic address: stephane.nancey@chu-lyon.fr.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Nancey
authors.affiliation: Hospices Civils de Lyon, Department of Gastroenterology, Lyon-Sud Hospital, Pierre-Bénite, France.
authors.forename: Driffa
authors.initials: D
authors.lastname: Moussata
authors.affiliation: Assistance Publique-Hopitaux de Paris, Department of Gastroenterology, Beaujon Hospital, Clichy, France.
authors.forename: Carmen
authors.initials: C
authors.lastname: Stefanescu
authors.affiliation: Department of Gastroenterology, Saint-Etienne University Hospital, Saint-Etienne, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Roblin
authors.affiliation: Hospices Civils de Lyon, Department of Gastroenterology, Lyon-Sud Hospital, Pierre-Bénite, France.
authors.forename: Marion
authors.initials: M
authors.lastname: Chauvenet
authors.affiliation: Hospices Civils de Lyon, Department of Gastroenterology, Lyon-Sud Hospital, Pierre-Bénite, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Stroeymeyt
authors.affiliation: Assistance Publique-Hopitaux de Paris, Department of Gastroenterology, Beaujon Hospital, Clichy, France.
authors.forename: Yoram
authors.initials: Y
authors.lastname: Bouhnik
authors.affiliation: INSERM U-1111 CIRI (International Center for Infectiology Research) and University Claude Bernard Lyon 1, Lyon, France; Hospices Civils de Lyon, Department of Gastroenterology, Lyon-Sud Hospital, Pierre-Bénite, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Flourié
mesh_terms: D000284:Administration, Oral; D000328:Adult; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D060828:Induction Chemotherapy; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D016559:Tacrolimus
keywords: Refractory; Tacrolimus; Treatment; Ulcerative colitis