title: Long-term efficacy of oral microemulsion cyclosporin for refractory ulcerative colitis.
abstract: OBJECTIVE
  The 60% bioavailable oral microemulsion formulation of cyclosporin (NEORAL ), has replaced the intravenous route to treat both organ transplant and immune-based disease. Its use for steroid-refractory ulcerative colitis (a recognized indication for intravenous cyclosporin) has been scanty.
  
  
  METHODS
  Twenty-three consecutive patients (14 male/9 female, universal colitis 14/23) entered a 3-month course of NEORAL (initially dosed at 5 mg/kg/day) because of steroid-refractoriness (14 cases) and steroid-dependence (9 cases). Responders (at least showing a 50% reduction of a clinical activity score) were continued on azathioprine. The initial steroid dose was tapered on commencing NEORAL; patients requiring steroid resumption or increase in the follow-up were defined as relapsers.
  
  
  RESULTS
  The target trough concentration of 200 ng/ml of whole blood was achieved without major titration in all but 1 patient. There were 7 non-responders (30%). Of the 16 responders (70%), 2 have not relapsed; the remaining 14 relapsed at the median time of 9.5 months (1.5-60) with 10 (71%) showing only 1 relapse. Five patients were colectomized 12 months after NEORAL (1.5-24), leaving 11 of the initial 23 (47%) with their colon. Of the 16, all but 1 had azathioprine; the median daily steroid needs fell from 32 to 5 mg.
  
  
  CONCLUSIONS
  The rates of acute and chronic response of 70% and 47% achieved by NEORAL in this indication duplicate the figures achieved by the traditional schedules of cyclosporin administration.
authors.affiliation: Department of Gastroenterology, Molinette Hospital, Turin, Italy. actis_g@libero.it
authors.forename: G C
authors.initials: GC
authors.lastname: Actis
authors.forename: M
authors.initials: M
authors.lastname: Lagget
authors.forename: M
authors.initials: M
authors.lastname: Rizzetto
authors.forename: M
authors.initials: M
authors.lastname: Fadda
authors.forename: A
authors.initials: A
authors.lastname: Palmo
authors.forename: M
authors.initials: M
authors.lastname: Pinna-Pintor
authors.forename: F
authors.initials: F
authors.lastname: Morino
mesh_terms: D000284:Administration, Oral; D001379:Azathioprine / Q000627:therapeutic use; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D004655:Emulsions; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D012008:Recurrence
chemical_list: D004655:Emulsions; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D001379:Azathioprine