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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.
Ann Rheum Dis. 2004 Sep; 63(9):1062-8.AR

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.

Authors+Show Affiliations

Department of Rheumatology, St Paul Medical Center, Dallas, Texas 75235, USA. stanleycohen@radiantresearch.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15082469

Citation

Cohen, S B., et al. "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." Annals of the Rheumatic Diseases, vol. 63, no. 9, 2004, pp. 1062-8.
Cohen SB, Moreland LW, Cush JJ, et al. 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. Ann Rheum Dis. 2004;63(9):1062-8.
Cohen, S. B., Moreland, L. W., Cush, J. J., Greenwald, M. W., Block, S., Shergy, W. J., Hanrahan, P. S., Kraishi, M. M., Patel, A., Sun, G., & Bear, M. B. (2004). 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. Annals of the Rheumatic Diseases, 63(9), 1062-8.
Cohen SB, et al. 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. Ann Rheum Dis. 2004;63(9):1062-8. PubMed PMID: 15082469.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Cohen,S B, AU - Moreland,L W, AU - Cush,J J, AU - Greenwald,M W, AU - Block,S, AU - Shergy,W J, AU - Hanrahan,P S, AU - Kraishi,M M, AU - Patel,A, AU - Sun,G, AU - Bear,M B, AU - ,, Y1 - 2004/04/13/ PY - 2004/4/15/pubmed PY - 2004/9/15/medline PY - 2004/4/15/entrez SP - 1062 EP - 8 JF - Annals of the rheumatic diseases JO - Ann Rheum Dis VL - 63 IS - 9 N2 - 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. SN - 0003-4967 UR - https://www.unboundmedicine.com/medline/citation/15082469/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_ L2 - https://ard.bmj.com/lookup/pmidlookup?view=long&amp;pmid=15082469 DB - PRIME DP - Unbound Medicine ER -