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The predicted pharmacokinetic differences between the regimens in JRA patients are of the same magnitude as the differences observed between twice weekly and weekly regimens in adult RA patients. The pharmacokinetics of ENBRELŪ in children < 4 years of age have not been studied. CLINICAL STUDIES Adult Rheumatoid Arthritis Text Continues Below
The safety and efficacy of ENBRELŪ were assessed in four randomized, double-blind, controlled studies. The results of all four trials were expressed in percentage of patients with improvement in RA using American College of Rheumatology (ACR) response criteria. Study I evaluated 234 patients with active RA who were = 18 years old, had failed therapy with at least one but no more than four disease-modifying antirheumatic drugs (DMARDs; e.g., hydroxychloroquine, oral or injectable gold, methotrexate [MTX], azathioprine, D-penicillamine, sulfasalazine), and had = 12 tender joints, = 10 swollen joints, and either ESR = 28 mm/hr, CRP > 2.0 mg/dL, or morning stiffness for = 45 minutes. Doses of 10 mg or 25 mg ENBRELŪ or placebo were administered SC twice a week for 6 consecutive months. Results from patients receiving 25 mg are presented in Table 1. Study II evaluated 89 patients and had similar inclusion criteria to Study I except that subjects in Study II had additionally received MTX for at least 6 months with a stable dose (12.5 to 25 mg/week) for at least 4 weeks and they had at least 6 tender or painful joints. Subjects in Study II received a dose of 25 mg ENBRELŪ or placebo SC twice a week for 6 months in addition to their stable MTX dose. Study III compared the efficacy of ENBRELŪ to MTX in patients with active RA. This study evaluated 632 patients who were = 18 years old with early (< 3 years disease duration) active RA; had never received treatment with MTX; and had = 12 tender joints, = 10 swollen joints, and either ESR = 28 mm/hr, CRP > 2.0 mg/dL, or morning stiffness for = 45 minutes. Doses of 10 mg or 25 mg ENBRELŪ were administered SC twice a week for 12 consecutive months. The study was unblinded after all patients had completed at least 12 months (and a median of 17.3 months) of therapy. The majority of patients remained in the study on the treatment to which they were randomized through 2 years, after which they entered an extension study and received open-label 25 mg ENBRELŪ. Results from patients receiving 25 mg are presented in Table 1. MTX tablets (escalated from 7.5 mg/week to a maximum of 20 mg/week over the first 8 weeks of the trial) or placebo tablets were given once a week on the same day as the injection of placebo or ENBRELŪ doses, respectively. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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