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Clinical trial: a multicentre, randomized, double‐blind, placebo‐controlled, dose‐finding, phase II study of subcutaneous interferon‐β‐1a in moderately active ulcerative colitis
Author(s) -
PENAROSSI C.,
SCHREIBER S.,
GOLUBOVIC G.,
MERTZNIELSEN A.,
PANES J.,
RACHMILEWITZ D.,
SHIEH M. J.,
SIMANENKOV V. I.,
STANTON D.,
GRAFFNER H.
Publication year - 2008
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2008.03778.x
Subject(s) - medicine , placebo , ulcerative colitis , adverse effect , gastroenterology , randomized controlled trial , clinical trial , immunology , surgery , pathology , disease , alternative medicine
Summary 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.