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Ann Rheum Dis 2004;63:1062-1068 doi:10.1136/ard.2003.016014
  • Extended report

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

  1. S B Cohen1,
  2. L W Moreland2,
  3. J J Cush3,
  4. M W Greenwald4,
  5. S Block5,
  6. W J Shergy6,
  7. P S Hanrahan7,
  8. M M Kraishi8,
  9. A Patel9,
  10. G Sun9,
  11. M B Bear9,
  12. the 990145 Study Group
  1. 1Department of Rheumatology, St Paul Medical Center, Dallas, Texas, USA
  2. 2Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Alabama, USA
  3. 3Arthritis Consultation Center, Presbyterian Hospital of Dallas, Dallas, Texas, USA
  4. 4Advances in Medicine, Rancho Mirage, California, USA
  5. 5Private Practice, Bangor, Maine, USA
  6. 6Rheumatology Associates of North Alabama, Huntsville, Alabama, USA
  7. 7Goatcher CRU, SCGH, and RPH, Perth, Australia
  8. 8St Clare’s Mercy Hospital, St Johns, Newfoundland, Canada
  9. 9Amgen, Thousand Oaks, California, USA
  1. Correspondence to:
    Dr S B Cohen
    Department of Rheumatology, St Paul Medical Center, 5939 Harry Hines Blvd, Suite 400, Dallas, TX 75235, USA; stanleycohenradiantresearch.net
  • Accepted 19 February 2004
  • Published Online First 13 April 2004

Abstract

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.

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