Induction and maintenance of clinical remission by interferon-beta in patients with steroid-refractory active ulcerative colitis-an open long-term pilot trial

Aliment Pharmacol Ther. 2002 Jul;16(7):1233-9. doi: 10.1046/j.1365-2036.2002.01264.x.

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.

Aim: 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.

Conclusion: 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.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / adverse effects
  • Adjuvants, Immunologic / therapeutic use*
  • Adolescent
  • Adult
  • Aged
  • Colitis, Ulcerative / drug therapy*
  • Drug Resistance
  • Female
  • Glucocorticoids / therapeutic use
  • Humans
  • Interferon Type I / adverse effects
  • Interferon Type I / therapeutic use*
  • Interferon-beta / adverse effects
  • Interferon-beta / therapeutic use*
  • Male
  • Middle Aged
  • Pilot Projects
  • Prospective Studies
  • Recombinant Proteins
  • Recurrence
  • Remission Induction
  • Treatment Outcome

Substances

  • Adjuvants, Immunologic
  • Glucocorticoids
  • Interferon Type I
  • Recombinant Proteins
  • Interferon-beta