AMGN reports RA data

AMGN said that in a U.S. Phase II/III study of 506 patients with rheumatoid arthritis (RA), 38% of patients given Kineret anakinra, an IL-1 receptor agonist, in combination with methotrexate (MTX) met the primary endpoint of an improved ACR20 score, compared to 22% in patients treated with placebo plus MTX. Also, 21% of Kineret patients achieved an ACR20 score by week 4, compared to 11% in control and more than twice as many Kineret patients compared to placebo patients achieved sustained ACR20 scores throughout the 24-week trial, 27% vs. 12% respectively. The most common adverse event was a mild reaction at the site of injection. Serious infections occurred in a 0.8% of Kineret and placebo treated group with no reports of tuberculosis or opportunistic infections in the Kineret group.

In a separate safety study of Kineret in 1,414 RA patients, the incidence of infectious episodes (the most frequently reported adverse event) was similar in Kineret-treated (41%) and placebo-treated (44%) groups. The rate of serious infections was 2% for Kineret compared to 0.4% for placebo. Kineret received a positive FDA panel recommendation in August (see BioCentury, Aug. 20). ...