European Commission Approves Kineret (Anakinra)/ Methotrexate Combo for Treatment of Rheumatoid Arthritis

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European Commission Approves Kineret (Anakinra)/ Methotrexate Combo for

Treatment of Rheumatoid Arthritis

THOUSAND OAKS, CA and LUCERNE, SWITZERLAND -- March 13, 2002 -- Amgen today

announced that the

European Commission has approved Kineret® (anakinra) for the treatment of the

signs and symptoms of rheumatoid

arthritis (RA) in combination with methotrexate, in patients with an inadequate

response to methotrexate alone.

Kineret is the first direct and selective blocker of interleukin-1 (IL-1), a

protein present in excess in RA patients. By

blocking IL-1, Kineret counteracts damaging cellular events in RA, reducing pain

and inflammation. Rheumatoid arthritis is

the most serious and disabling type of arthritis, affecting more than three

million Europeans.

" Kineret is the first therapy from Amgen's rheumatology research program and

demonstrates our commitment to

discovering and developing new medicines for the treatment of inflammation, "

said Sharer, Amgen's Chairman and

Chief Executive Officer. "

Leonard, Amgen's Vice President for European operations added, " Kineret is

a significant new treatment for patients

with RA, which reduces the signs and symptoms of the disease and improves some

measurements of patient function.

Our studies demonstrate that Kineret is well tolerated and has a favourable

safety profile. Kineret represents an important

new therapy for patients with RA whose symptoms are not controlled by

methotrexate therapy alone. "

Approval of Kineret was based on more than 2,600 patients treated with Kineret

in randomized, double-blinded, placebo-

controlled clinical trials. Kineret, taken in combination with methotrexate,

improves the signs and symptoms of RA. Many

clinical responses, including a decrease in inflammation and pain, were seen by

the fourth week of treatment and most

were seen by week 13.

After six months of Kineret therapy in a confirmatory efficacy study (n=501), 38

percent of Kineret patients (n=250) as

compared with 22 percent of placebo patients (n=251) achieved a 20 percent

improvement in the American College of

Rheumatology (ACR) score (ACR20). These patients were receiving background

methotrexate therapy. ACR20 criteria

include a 20 percent improvement in the number of swollen and tender joints,

plus a greater than or equal to 20 percent

improvement in at least three of five of the following criteria: physician

assessment of disease, patient assessment of

disease, pain, C-reactive protein (a general laboratory marker of inflammation)

and health assessment questionnaire.

" For rheumatoid arthritis patients, maintaining a 'normal' lifestyle in terms of

function and being able to work, are extremely

high priorities, " said Prof. Barry Bresnihan, Professor of Rheumatology at St.

's University Hospital, Dublin, Ireland

and a clinical investigator in the Kineret trials. " Kineret represents an

important new treatment option for patients with

rheumatoid arthritis and has been shown to improve patient signs and symptoms. "

Throughout the clinical trial program Kineret was shown to be well tolerated and

to have a favourable safety profile. The

most common side effect was a reaction at the site of injection, usually mild to

moderate, characterized by redness,

swelling and pain. There was an increased risk of serious infections (2 percent

in Kineret patients vs. less than 1 percent

in placebo patients) in the clinical trials. Although Kineret should be

discontinued if a patient develops an infection, most

patients can continue taking Kineret after their infection resolves. Kineret

should not be used with TNF blocking agents

etanercept and infliximab.

Preliminary data suggest a higher incidence of serious infection (7 percent) and

the occurrence of neutropenia (3 percent)

when Kineret is used with these agents. "

SOURCE: Amgen