title: Induction and maintenance of clinical remission by interferon-beta in patients with steroid-refractory active ulcerative colitis-an open long-term pilot trial.
abstract: BACKGROUND
  The imbalance of pro- and anti-inflammatory cytokines plays an important role in the pathogenesis of inflammatory bowel disease. Shifting this disturbed ratio by means of TNF-antibodies or interferon has been shown to be helpful in treating Crohn's disease and multiple sclerosis, respectively.
  
  
  OBJECTIVE
  This pilot study investigated whether interferon-beta can induce clinical remission in corticoid-refractory ulcerative colitis.
  
  
  METHODS
  Twenty-five patients with steroid-refractory active ulcerative colitis (Clinical activity index according to Rachmilewitz: 13.5 +/- 5.2) were treated in an open pilot trial with 0.5 MIU human natural interferon-beta (hn-IFN-beta) i.v. (n=18) or 1 MIU recombinant interferon-beta-1a (r-IFN-beta-1-a) s.c. (n=7) daily with the goal of induction of remission. Subsequent maintenance treatment was carried out for 52.0 +/- 78.8 weeks (range 4-336 weeks) with the same dose, three times per week.
  
  
  RESULTS
  Twenty-two of 25 patients (88%) went into remission during induction treatment (hn-IFN-beta 16/18, r-IFN-beta-1a 6/7). Mean time to response was 3.0 +/- 1.3 weeks. Mean length of remission was 13.0 +/- 19.7 months. Only eight of 22 patients in remission relapsed during maintenance treatment. Five of these went into remission again after increasing the dose. Adverse events consisted of slight to moderate flu-like symptoms and slight to moderate hair loss in five of 15 female patients.
  
  
  CONCLUSIONS
  Although this open pilot study included only a small number of patients, the high response rate suggests that interferon-beta may be a safe and effective treatment for steroid-refractory active ulcerative colitis.
authors.affiliation: Department of Internal Medicine, Marienhospital Bottrop, Germany. eugen.musch@mhb-bottrop.de
authors.forename: E
authors.initials: E
authors.lastname: Musch
authors.forename: T
authors.initials: T
authors.lastname: Andus
authors.forename: M
authors.initials: M
authors.lastname: Malek
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004351:Drug Resistance; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D007370:Interferon Type I / Q000009:adverse effects / Q000627:therapeutic use*; D016899:Interferon-beta / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011994:Recombinant Proteins; D012008:Recurrence; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D005938:Glucocorticoids; D007370:Interferon Type I; D011994:Recombinant Proteins; D016899:Interferon-beta