title: Cyclosporine in severe ulcerative colitis refractory to steroid therapy.
abstract: BACKGROUND
  There has been no new effective drug therapy for patients with severe ulcerative colitis since corticosteroids were introduced almost 40 years ago. In an uncontrolled study, 80 percent of 32 patients with active ulcerative colitis refractory to corticosteroid therapy had a response to cyclosporine therapy.
  
  
  METHODS
  We conducted a randomized, double-blind, controlled trial in which cyclosporine (4 mg per kilogram of body weight per day) or placebo was administered by continuous intravenous infusion to 20 patients with severe ulcerative colitis whose condition had not improved after at least 7 days of intravenous corticosteroid therapy. A response to therapy was defined as an improvement in a numerical symptom score (0 indicated no symptoms, and 21 severe symptoms) leading to discharge from the hospital and treatment with oral medications. Failure to respond to therapy resulted in colectomy, but some patients in the placebo group who had no response and no urgent need for surgery were subsequently treated with cyclosporine.
  
  
  RESULTS
  Nine of 11 patients (82 percent) treated with cyclosporine had a response within a mean of seven days, as compared with 0 of 9 patients who received placebo (P < 0.001). The mean clinical-activity score fell from 13 to 6 in the cyclosporine group, as compared with a decrease from 14 to 13 in the placebo group. All five patients in the placebo group who later received cyclosporine therapy had a response.
  
  
  CONCLUSIONS
  Intravenous cyclosporine therapy is rapidly effective for patients with severe corticosteroid-resistant ulcerative colitis.
authors.affiliation: Department of Medicine, Mt. Sinai School of Medicine, New York, NY.
authors.forename: S
authors.initials: S
authors.lastname: Lichtiger
authors.forename: D H
authors.initials: DH
authors.lastname: Present
authors.forename: A
authors.initials: A
authors.lastname: Kornbluth
authors.forename: I
authors.initials: I
authors.lastname: Gelernt
authors.forename: J
authors.initials: J
authors.lastname: Bauer
authors.forename: G
authors.initials: G
authors.lastname: Galler
authors.forename: F
authors.initials: F
authors.lastname: Michelassi
authors.forename: S
authors.initials: S
authors.lastname: Hanauer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003082:Colectomy; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000601:surgery; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000627:therapeutic use; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic
chemical_list: D016572:Cyclosporine; D006854:Hydrocortisone