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 -