New data suggest anakinra may accelerate reduction in joint destruction and improve quality of life for rheumatoid arthritis patients

PHILADELPHIA, Pa., October 29, 2000 - Amgen (NASDAQ: AMGN) today announced that anakinra or interleukin-1 receptor antagonist (IL-1ra), an investigational rheumatoid arthritis (RA) therapy not yet approved by the U.S. Food and Drug Administration, may accelerate reduction in joint damage progression and improvement in the health-related quality of life for RA patients, according to results of several studies presented this week at the American College of Rheumatology (ACR) annual meeting.

Bone and Joint Data

In a double-blind, multicenter study, 472 patients were randomized to receive 30 mg, 75 mg or 150 mg daily treatment or placebo. After 6 months, the placebo patients were re-randomized to treatment with one of the anakinra doses. The patients were evaluated by radiographs using a modified Sharp assessment tool, which measures joint destruction based on erosive damage and joint space narrowing of the hand and wrist. The sum of these two subscales provides the total Sharp score. Increases in scores signify progressive structural destruction.

In the first analysis, patients treated with anakinra for a full year experienced an accelerated slowing of joint destruction in the second 6-month period relative to the significant improvements in the first 6 months of treatment. After six months, anakinra-treated patients experienced nearly twice the rate of reduction in joint destruction as the placebo group (increase in Sharp score of 1.86 vs. 3.61, respectively, p=0.002). After an additional six months of therapy, patients on anakinra experienced an increase of 1.18 compared with 1.32 in the placebo group (p<0.001). This accelerated improvement in benefit was seen at both 75 and 150 mg doses.

"Not only did patients on anakinra see benefits as early as six months on treatment, but the longer they were on therapy, the more improvement they experienced," said co-author Dr. Barry Bresnihan, professor of rheumatology, University Col

Contact: Rebecca Hamm, Amgen
Porter Novelli

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