title: Colectomy rate in steroid-refractory colitis initially responsive to cyclosporin: a long-term retrospective cohort study.
abstract: BACKGROUND
  There is consistent evidence that 50% of patients with acute, steroid-resistant flare of ulcerative colitis (UC) may achieve remission and avoid colectomy if treated with cyclosporin (CsA). However, follow-up of the responders has shown that most of them relapse and need surgery shortly after the response. We compared the records of our CsA-treated patients with those of other groups in order to help clarify this matter.
  
  
  METHODS
  All patients admitted consecutively to our Unit with an attack of UC and treated with CsA between January 1991 and December 1999 were studied. Patients were begun on continuously-infused CsA at 2 mg/kg/day (1991-1996), or on NEORAL at an initial dose of 5 mg/kg/day (1996-1999). The maintenance treatment included oral CsA for 3-6 months with or without azathioprine (AZA). CsA failure was defined as a relapse requiring steroids with or without progression to colectomy; the cumulative probability of relapse/colectomy was assessed by Fisher's exact tests and Kaplan-Meier analysis.
  
  
  RESULTS
  Among the patients, 39/61 (63%) initially responded. These 39 included a fatality and 4 drop-outs (unrelated to the side-effects of CsA), leaving 34 patients for the study. Of these, 61% and 35% were colectomy-free at 1 and 7 years, respectively; the corresponding figures were 80 and 60% respectively in the subset treated with AZA, but 47% and 15% in the AZA-untreated subgroup (p= 0.0007 at 7 years). Among the 34 patients, 44% were relapse-free at 1 year, but all had relapsed at 7 years (p = 0.0635). The overall resort to colectomy was 72%, while 19% of the patients remained colectomy-free.
  
  
  CONCLUSIONS
  Sixty percent of a cohort of patients with steroid-refractory colitis responded to CsA and 60% of these responders retained the colon after 1 year. These figures fell to 35% at 7 years but improved to 60% on AZA. The overall need for colectomy remains high in these patients and toxicity must be monitored.
authors: Department of Digestive Disease and Nutrition, Ospedale Molinette, Torino, Italy. actis_g@libero.it
authors: Giovanni C
authors: GC
authors: Actis
authors: Maurizio
authors: M
authors: Fadda
authors: Ezio
authors: E
authors: David
authors: Anna
authors: A
authors: Sapino
mesh_terms: D000284:Administration, Oral; D000328:Adult; D016009:Chi-Square Distribution; D015331:Cohort Studies; D003082:Colectomy / Q000379:methods / Q000706:statistics & numerical data*; D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery*; D016572:Cyclosporine / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004351:Drug Resistance; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000627:therapeutic use; D011336:Probability; D012008:Recurrence; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D016572:Cyclosporine; D011239:Prednisolone