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Logo of annrheumdAnnals of the Rheumatic DiseasesVisit this articleSubmit a manuscriptReceive email alertsContact usBMJ
Ann Rheum Dis. 2004 September; 63(9): 1062–1068.
Published online 2004 April 13. doi:  10.1136/ard.2003.016014
PMCID: PMC1755108

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


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.

Figure 1
 (A) Proportions of patients in the anakinra (n = 250) and placebo (n = 251) groups with ACR20, ACR50, and ACR70 responses at the end of the 24 week study period. (B) Proportions of patients completing the study in the anakinra (n = 200) and ...
Figure 2
 (A) Changes in physician assessment of patient disease activity in the anakinra (n = 250) and placebo (n = 251) groups, by study week. (B) Changes in swollen joint count in the anakinra (n = 250) and placebo (n = 251) groups. (C) Changes in ...
Figure 3
 (A) Log transformed changes in CRP levels in the anakinra (n = 250) and placebo (n = 251) groups at each study assessment. (B) Changes in ESR in the anakinra and placebo groups at each study assessment. Comparisons between study drugs shown ...

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