Kineret Improves Symptoms of Rheumatoid Arthritis

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Kineret Improves Symptoms of Rheumatoid Arthritis

By Schorr

SAN FRANCISCO (MedscapeWire) Nov 16 - The drug anakinra relieved symptoms in a

significant proportion of patients with erosive rheumatoid arthritis, according

to findings of a study presented here Thursday at the 65th annual meeting of the

American College of Rheumatology.

" This study confirms previous reports that anakinra results in improvements in

the treatment of rheumatoid arthritis, " said lead investigator Dr. Stanley B.

Cohen, a clinical associate professor of internal medicine at the University of

Texas Southwestern Medical School in Dallas, Texas.

Amgen, the Thousand Oaks, California-based biotech company that manufactures the

drug under the brand name Kineret, announced Wednesday that it has received US

Food and Drug Administration FDA approval to market the drug for patients

suffering from rheumatoid arthritis unhelped by traditional anti-rheumatoid

drugs.

The drug will be the first direct and selective interleukin-1 (IL-1) receptor

antagonist on the US market, which works by blocking the IL-1 protein

responsible for contributing to inflammation in rheumatoid arthritis.

In partial findings presented from the ongoing clinical trial, researchers

reported on 501 adult patients who had experienced at least 6 months of active

rheumatoid arthritis and had radiographic evidence of at least 1 bone erosion in

their hand or foot. Three-quarters of the patients were women (average age, 57

years) who had suffered from rheumatoid arthritis for around a decade.

The patients were randomly assigned to continue on their standard treatment of

the antirheumatoid agent methotrexate or to receive, in addition, 100 mg of

anakinra injections daily.

The ongoing study hopes to eventually evaluate whether the drug can actually

delay or stop disease progression. The researchers presented secondary endpoints

here of whether the drug could alleviate rheumatoid symptoms after 6 months.

Nearly twice the patients receiving anakinra showed a 20% improvement in

criteria set by the American College of Rheumatology, including tender and

swollen joints and self-assessed pain and disability, compared with those who

received methotrexate alone. Of the patients in the anakinra treatment group,

38% showed improvement in symptoms compared with 22% of those continuing on

methotrexate alone.

The patients on anakinra were more likely to have a quick response, with 21%

showing improvements after 4 weeks compared with 11% of the patients on

methotrexate alone, and were also twice as likely to sustain their response.

" The placebo group had a response, but it tended to plateau after week 12, "

Cohen noted.

Adverse effects included injection site reactions, which were experienced by 65%

of the patients on anakinra compared with 24% of the patients on methotroxate

alone. Patients receiving anakinra also were more likely to experience upper

respiratory infections (21% with anakinra vs 15% with placebo).

Patients receiving anakinra were also more likely to withdraw from the study due

to these reactions (8%) than the patients in the methotrexate group (less than

1%). However, Cohen noted, both groups of patients had similar rates of

suffering serious adverse events.