Clinical trial: a multicentre, randomized, double-blind, placebo-controlled, dose-finding, phase II study of subcutaneous interferon-beta-la in moderately active ulcerative colitis

Aliment Pharmacol Ther. 2008 Sep 15;28(6):758-67. doi: 10.1111/j.1365-2036.2008.03778.x.


Background: Ulcerative colitis (UC) pathophysiology is characterized by an imbalance between pro- and anti-inflammatory cytokines. Interferon (IFN)-beta-1a has potent immunoregulatory properties, including stimulation of host defence mechanisms and thus represents a potential treatment.

Aim: To extend pilot data and identify a suitable dose of IFN-beta-1a to achieve endoscopically confirmed remission (ECR) in patients with moderately active UC and to evaluate safety.

Methods: In this multicentre, double-blind, placebo-controlled trial, adults with moderately active UC were randomized to IFN-beta-1a 44 or 66 microg, or placebo, subcutaneously three times weekly for 8 weeks, with a 4-week follow-up.

Results: Endoscopically-confirmed remission was observed in 23.4% [95% confidence interval (CI): 13.8-35.7] of placebo patients, 29.2% (95% CI: 18.6-41.8) of the IFN-beta-la 44 microg group and 20.0% (950% CI: 11.1-31.8) of the 66 microg group (P = 0.45). Improvements with IFN-beta-1a 44 microg were greater than with placebo for most secondary efficacy outcomes, although significance was not achieved. Placebo response rates were higher than expected from previous trials. Adverse events were similar to the known safety profile of IFN treatment.

Conclusions: Interferon-beta-1a was generally well tolerated at the doses tested, but a significant therapeutic benefit in patients with UC was not observed.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / pathology
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Endoscopy, Gastrointestinal
  • Europe / epidemiology
  • Female
  • Humans
  • Immunologic Factors / therapeutic use*
  • Injections, Subcutaneous
  • Interferon-beta / therapeutic use*
  • Male
  • Placebos
  • Quality of Life
  • Remission Induction
  • Severity of Illness Index
  • Treatment Outcome


  • Immunologic Factors
  • Placebos
  • Interferon-beta