Abstract
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Alimentary Pharmacology and Therapeutics |
| Vol/bind | 28 |
| Udgave nummer | 6 |
| Sider (fra-til) | 758-67 |
| ISSN | 0269-2813 |
| DOI | |
| Status | Udgivet - 2008 |
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I: Alimentary Pharmacology and Therapeutics, Bind 28, Nr. 6, 2008, s. 758-67.
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review
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TY - JOUR
T1 - Clinical trial: a multicentre, randomized, double-blind, placebo-controlled, dose-finding, phase II study of subcutaneous interferon-beta-1a in moderately active ulcerative colitis
AU - Pena-Rossi, C
AU - Schreiber, S
AU - Golubovic, G
AU - Mertz-Nielsen, A
AU - Panes, J
AU - Rachmilewitz, D
AU - Shieh, M J
AU - Simanenkov, V I
AU - Stanton, D
AU - Graffner, H
PY - 2008
Y1 - 2008
N2 - 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 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 mcg, or placebo, subcutaneously three times weekly for 8 weeks, with a 4-week follow up. Results ECR 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-1a 44 mcg group and 20.0% (95% CI: 11.1-31.8) of the 66 mcg group (P = 0.45). Improvements with IFN-beta-1a 44 mcg 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 IFN-beta-1a was generally well tolerated at the doses tested, but a significant therapeutic benefit in patients with UC was not observed.
AB - 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 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 mcg, or placebo, subcutaneously three times weekly for 8 weeks, with a 4-week follow up. Results ECR 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-1a 44 mcg group and 20.0% (95% CI: 11.1-31.8) of the 66 mcg group (P = 0.45). Improvements with IFN-beta-1a 44 mcg 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 IFN-beta-1a was generally well tolerated at the doses tested, but a significant therapeutic benefit in patients with UC was not observed.
U2 - 10.1111/j.1365-2036.2008.03778.x
DO - 10.1111/j.1365-2036.2008.03778.x
M3 - Journal article
SN - 0269-2813
VL - 28
SP - 758
EP - 767
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
IS - 6
ER -