title: Interferon-beta-1a for the treatment of steroid-refractory ulcerative colitis: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  We performed a randomized, double-blind, placebo-controlled, multicenter trial to investigate the efficacy and safety of recombinant interferon-beta-1a (rIFN-beta-1a) in outpatients with active steroid-refractory ulcerative colitis.
  
  
  METHODS
  Ninety-one randomized patients subcutaneously received 3 MIU rIFN-beta-1a (group A, n = 32), 1 MIU rIFN-beta-1a (group B, n = 30), or placebo (group C, n = 29) 3 times a week over a period of 8 weeks in addition to standard therapy. An intention-to-treat analysis was performed to evaluate the efficacy and safety of treatment.
  
  
  RESULTS
  In all 3 groups, the median prestudy clinical activity index (CAI) was 10. In 18 of 32 patients (56%) in group A, in 11 of 30 patients (36%) in group B, and in 10 of 29 patients (34%) in group C, a reduction of the CAI of 6 points or greater (response) was achieved (differences were not statistically significant). Complete response (reduction of CAI to < or =4) was achieved in 56%, 30%, and 38% of patients in groups A, B, and C, respectively. Compared with baseline, the median endoscopic index had been reduced by 5, 3, and 4 points in groups A, B, and C, respectively. Steroid reduction was 12 mg in group A, 6 mg in group B, and 10 mg in group C. Identical side effects occurred in all 3 groups. Seven serious adverse events were reported (1 in group A and 6 in group C). All were unrelated to therapy as judged by the investigating physicians.
  
  
  CONCLUSIONS
  rIFN-beta-1a was safe but not significant, at the dosage and/or duration of treatment used, in steroid-refractory ulcerative colitis. Further studies are indicated.
authors.affiliation: Department of Internal Medicine, Marienhospital Bottrop, Bottrop, Germany. eugen.musch@mhb-bottrop.de
authors.forename: Eugen
authors.initials: E
authors.lastname: Musch
authors.forename: Tilo
authors.initials: T
authors.lastname: Andus
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Kruis
authors.forename: Andreas
authors.initials: A
authors.lastname: Raedler
authors.forename: Martina
authors.initials: M
authors.lastname: Spehlmann
authors.forename: Stefan
authors.initials: S
authors.lastname: Schreiber
authors.forename: Bernd
authors.initials: B
authors.lastname: Krakamp
authors.forename: Mouhamad
authors.initials: M
authors.lastname: Malek
authors.forename: Helmut
authors.initials: H
authors.lastname: Malchow
authors.forename: Filip
authors.initials: F
authors.lastname: Zavada
authors.forename: Gerhard
authors.initials: G
authors.lastname: Engelberg Feurle
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D003113:Colonoscopy; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000009:adverse effects*; D006801:Humans; D007279:Injections, Subcutaneous; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D012189:Retrospective Studies; D012449:Safety; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D005938:Glucocorticoids; D016899:Interferon-beta; D000068556:Interferon beta-1a