RESEARCH - A multicentre, double blind, randomised, placebo controlled trial of anakinra (Kineret)

[Guest guest]

Ann Rheum Dis. 2004 Sep;63(9):1062-8. Epub 2004 Apr 13

A multicentre, double blind, randomised, placebo controlled trial of

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

patients with rheumatoid arthritis treated with background methotrexate.

Cohen SB, Moreland LW, Cush JJ, Greenwald MW, Block S, Shergy WJ,

Hanrahan PS, Kraishi MM, Patel A, Sun G, Bear MB; 990145 Study Group.

Department of Rheumatology, St Medical Center, Dallas, Texas 75235,

USA. stanleycohen@...

OBJECTIVE: To assess the efficacy and safety of 100 mg daily anakinra

(Kineret), a recombinant form of the naturally occurring interleukin 1

receptor antagonist, plus methotrexate (MTX) in reducing the signs and

symptoms of rheumatoid arthritis (RA). METHODS: Patients with active RA (n =

506) despite current treatment with MTX were enrolled in this multicentre,

double blind, randomised, placebo controlled study. Patients received

subcutaneous injections of anakinra 100 mg/day or placebo. They were

assessed monthly for 6 months for improvement in signs and symptoms of RA

and for adverse events. The primary efficacy measure was the percentage of

patients attaining ACR20 response at week 24. RESULTS: Significantly greater

proportions of patients treated with anakinra compared with placebo achieved

ACR20 (38% v 22%; p<0.001), ACR50 (17% v 8%; p<0.01), and ACR70 (6% v 2%;

p<0.05) responses. The response to anakinra was rapid; 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 ACR response (for example, Health Assessment

Questionnaire, pain, C reactive protein levels, and erythrocyte

sedimentation rate). Anakinra was well tolerated, with a safety profile,

similar to that of placebo with one exception: mild to moderate injection

site reactions were more common with anakinra than with placebo (65% v 24%).

CONCLUSIONS: This study confirms previous observations from a dose-ranging

study showing that anakinra, in combination with MTX, is an effective and

safe treatment for patients with RA who have inadequate responses to MTX

alone.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_ui

ds=15082469 & dopt=Abstract