Abstract:
BACKGROUND:Randomized, placebo controlled trials are used to assess the efficacy of therapies for Crohn's disease. The placebo response and remission rates vary among studies. AIM:To analyse how the placebo response and remission rates in Crohn's trials have changed over time in the era of parenteral biologic therapies. METHODS:A search for randomized, placebo-controlled trials of parenteral biologic therapies for active Crohn's disease was conducted using online databases. The placebo response and remission rates and study week of evaluation were recorded for each trial. The placebo response and remission rates were analysed as functions of publication date and study week of evaluation. RESULTS:The odds of a placebo-induced remission and response significantly increased as the week of evaluation increased. The placebo remission rate increased significantly with year of publication. Adjusted for week of evaluation, this increase in placebo remission rate over time was no longer significant. The increase in the placebo response over this time period was not statistically significant. CONCLUSION:The observed increase in placebo remission rates over time in trials of parenteral biologic therapies in Crohn's disease is explained by longer times to the primary endpoint in more recent trials.
journal_name
Aliment Pharmacol Therjournal_title
Alimentary pharmacology & therapeuticsauthors
Gallahan WC,Case D,Bloomfeld RSdoi
10.1111/j.1365-2036.2009.04125.xsubject
Has Abstractpub_date
2010-01-01 00:00:00pages
102-7issue
1eissn
0269-2813issn
1365-2036pii
APT4125journal_volume
31pub_type
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