Amgen's interleukin-1 receptor antagonist anakinra has been shown toarrest joint destruction and improve function in a 472-patient study in rheumatoid arthritis, presented at the EULAR 2001 meeting. The Phase II study compared placebo to three doses of anakinra (30mg, 75mg and 150mg/day) for six months, and joint function was evaluated using radiography.
After 24 weeks of treatment, 31% of the anakinra group and 16.7% of those on placebo demonstrated an arrest of progressive joint damage (p<0.05). Health Assessment Questionnaire scores taken at the same timepoint showed a significant and clinically-meaningful improvement in patients' ability to function compared to placebo (p=0.0003). Additionally, anakinra-treated patients displayed an increase in productivity (reduction of lost days of work or domestic activity). These gains occurred rapidly, with over a two-day gain by week eight of treatment. By the end of the six-month follow-up, 14% of the anakinra-treated patients had not missed any work or domestic activities, compared to 6% of the placebo group.
Anakinra has been submitted for regulatory approval in the USA, Canada and the European Union, and first approvals are expected in the second half of this year.
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