Clinical trial: A multicentre, randomized, double-blind, placebo-controlled, dose-finding, phase II study of subcutaneous interferon-β-1a in moderately active ulcerative colitis
Journal
Alimentary Pharmacology and Therapeutics
Journal Volume
28
Journal Issue
6
Pages
758-767
Date Issued
2008
Author(s)
Pena-Rossi C.
Schreiber S.
Golubovic G.
Mertz-Nielsen A.
Panes J.
Rachmilewitz D.
Simanenkov V.I.
Stanton D.
Graffner H.
Abstract
Background: Ulcerative colitis (UC) pathophysiology is characterized by an imbalance between pro- and anti-inflammatory cytokines. Interferon (IFN)-β-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-β-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-β-1a 44 or 66 μg, 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-β-1a 44 μg group and 20.0% (95% CI: 11.1-31.8) of the 66 μg group (P = 0.45). Improvements with IFN-β-1a 44 μg 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-β-1a was generally well tolerated at the doses tested, but a significant therapeutic benefit in patients with UC was not observed. ? 2008 The Authors.
SDGs
Other Subjects
beta1a interferon; mesalazine; placebo; adult; aminotransferase blood level; anemia; arthralgia; article; clinical trial; controlled clinical trial; controlled study; Croatia; cytopenia; disease duration; dose calculation; double blind procedure; drug dose comparison; drug efficacy; drug safety; drug tolerability; drug withdrawal; endoscopy; female; fever; flu like syndrome; headache; hepatobiliary disease; human; hypokalemia; injection site inflammation; injection site pain; injection site reaction; maintenance therapy; major clinical study; malaise; male; mental disease; multicenter study; myalgia; phase 2 clinical trial; priority journal; quality of life; randomized controlled trial; remission; Russian Federation; side effect; smoking; statistical analysis; thrombocytopenia; thyroid disease; ulcerative colitis; Western Europe; Adult; Colitis, Ulcerative; Dose-Response Relationship, Drug; Double-Blind Method; Drug Toxicity; Endoscopy, Gastrointestinal; Europe; Female; Humans; Immunologic Factors; Injections, Subcutaneous; Interferon-beta; Male; Placebos; Quality of Life; Remission Induction; Severity of Illness Index; Treatment Outcome
Type
journal article