RESEARCH - Kineret (anakinra) pivotal trial published

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Anakinra pivotal trial published

Rheumawire

Sep 9, 2004

Nainggolan

Dallas, TX - One of the pivotal trials submitted for the US approval of

the interleukin 1 antagonist, anakinra (Kineret®; Amgen), has been

published in the ls of Rheumatic Diseases[1].

In the 506-patient study, approximately twice as many rheumatoid

arthritis (RA) patients treated with anakinra and methotrexate had

ACR20, 50, and 70 responses compared with those who took placebo plus

methotrexate.

Lead author Dr Stanley B Cohen (St Medical Center, Dallas, TX) told

rheumawire the study was first presented at the ACR meeting in

Philadelphia in 1999, and was used for the approval of anakinra in the

US.

" What this study does is confirm that the dose of anakinra commonly used

in the clinic100mg daily is safe and effective when used in combination

with methotrexate in patients with RA, " Cohen says.

He adds that it is now widely recognized amongst rheumatologists that

most of the biologic agents are better used in combination with

methotrexate. " General practice is to use methotrexate first, and then

for the two thirds who don't respond to it, add in a biologic, " he

notes.

In the study, Cohen et al recruited 506 RA patients with active disease

despite current treatment with methotrexate and randomized them to

anakinra 100mg/day sc or placebo. They were assessed monthly for 6

months for improvement in signs and symptoms of RA and for adverse

events. The primary endpoint was the percentage of patients attaining

ACR20 response at week 24.

More patients treated with anakinra compared with placebo achieved ACR20

(38% versus 22%; p<0.001) ACR50 (17% versus 8%; p<0.01) and ACR70 (6%

versus 2%; p<0.05) responses at 24 weeks, and " the response to anakinra

was rapid, " the researchers note; the proportion of patients with an

ACR20 response at the first study assessment (4 weeks) was twice as high

with anakinra as with placebo (p<0.005).

" Clinically meaningful and statistically significant responses were also

seen in individual components of the ACR20 response, " they add.

Anakinra was also well tolerated in the study, the researchers say. It

had a safety profile similar to that of placebo with one exception: mild

to moderate injection site reactions were more common with anakinra that

with placebo (65% versus 24%). Most patients had their first injection

site reaction during the first month of the study and the risk of

experiencing such a reaction for the first time after the first month of

treatment was low, they conclude.

Source

S B Cohen, L W Moreland, J J Cush et al. A multicenter

double-blind, randomized, placebo-controlled trial of anakinra

(Kineret), a recombinant interleukin 1 receptor antagonist, in patients

with rheumatoid arthritis treated with background methotrexate. Ann

Rheum Dis 2004; 63:1062-1068.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org