Interferon-beta-1a for the treatment of steroid-refractory ulcerative colitis: a randomized, double-blind, placebo-controlled trial.

Abstract

BACKGROUND & AIMS:

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: Eugen Musch, Tilo Andus, Wolfgang Kruis, Andreas Raedler, Martina Spehlmann, Stefan Schreiber, Bernd Krakamp, Mouhamad Malek, Helmut Malchow, Filip Zavada, Gerhard Engelberg Feurle
• Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (Clin Gastroenterol Hepatol) Vol. 3 Issue 6 Pg. 581-6 (Jun 2005) ISSN: 1542-3565 [Print] United States
• PMID: 15952100 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adjuvants, Immunologic
• Glucocorticoids
• Interferon-beta
• Interferon beta-1a

Topics

• Adjuvants, Immunologic (administration & dosage, therapeutic use)
• Adult
• Colitis, Ulcerative (drug therapy, pathology)
• Colonoscopy
• Double-Blind Method
• Female
• Follow-Up Studies
• Glucocorticoids (adverse effects)
• Humans
• Injections, Subcutaneous
• Interferon beta-1a
• Interferon-beta (administration & dosage, therapeutic use)
• Male
• Retrospective Studies
• Safety
• Treatment Outcome