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| |  Golimumab Effective in Patients With Rheumatoid Arthritis Not Responding to Methotrexate: Presented at EULAR By Bruce Sylvester PARIS -- June 15, 2008 -- Patients whose rheumatoid arthritis (RA) is active despite treatment with methotrexate show significant improvements in signs and symptoms of disease when treated with the investigative agent golimumab, said researchers in a newly reported phase 3 study. "Combination of golimumab with methotrexate appears to be better than methotrexate alone or golimumab alone in reducing signs and symptoms of rheumatoid arthritis," Edward Keystone, MD, University of Toronto Medical School, Toronto, Ontario, said in his presentation on June 12 at EULAR 2008, the Annual Congress of the European League Against Rheumatism. In this multicentre, double-blind, placebo-controlled study, the investigators randomised adult patients with active RA (4 or more tender and swollen joints) despite methotrexate treatment to receive either placebo injections plus methotrexate (n = 133), golimumab 100-mg injections plus placebo (n = 133), golimumab 50-mg injections plus methotrexate (n = 89), or golimumab 100-mg injections plus methotrexate (n = 89). Injections were given every 4 weeks. Primary endpoints were the proportion of patients achieving 20% improvement in the American College of Rheumatology response criteria (ACR20) at week 14 and the improvement from baseline in Health Assessment Questionnaire (HAQ) scores at week 24. Data through week 24 were presented. The investigators enrolled 444 subjects with active RA. They balanced the treatment groups for baseline demographic and disease characteristics. Golimumab plus methotrexate treatment was significantly better than placebo plus methotrexate for improving the signs and symptoms of RA (55.6 vs 33.1%, respectively, reaching ACR20 by week 14, P < .001) as well as in improving physical function [HAQ score improvements] by 0.44 vs 0.13, respectively, by week 24, P < .001). Both golimumab dosing groups achieved comparable efficacy. The golimumab monotherapy group achieved numerically better efficacy parameters than the methotrexate monotherapy group, but the differences were not statistically significant. Golimumab was generally well tolerated. Through week 16, the percentages of patients who reported >=1 adverse event was 60.9%, 63.2%, 68.5%, and 69.7% for placebo plus methotrexate, golimumab 100 mg plus placebo, golimumab 50 mg plus methotrexate, and golimumab 100 mg plus methotrexate, respectively. Serious adverse events occurred in 2.3%, 3.8%, 5.6%, and 9.0% of patients, respectively. Serious infections occurred in 0.8%, 2.3%, 2.2%, and 5.6% of patients, respectively. Injection-site reactions occurred in 0.0%, 5.3%, 3.4%, and 4.5% of patients, respectively. One patient receiving golimumab100 mg plus placebo died due to diarrhoea, colitis, and sepsis. The investigators reported 3 malignancies: 1 breast cancer (golimumab 100 mg plus methotrexate), 1 Bowen's disease and squamous-cell skin cancer (golimumab 100 mg plus placebo), and 1 basal-cell carcinoma (placebo plus methotrexate). They reported no tuberculosis or opportunistic infections. The authors concluded, "In patients with active rheumatoid arthritis despite methotrexate, the addition of golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks to methotrexate significantly reduced the signs and symptoms of rheumatoid arthritis and improved physical function through week 24. Golimumab was generally well tolerated with a safety profile consistent with other available anti-TNF-alpha biologics." The study was supported by Centocor Research and Development, Inc. [Presentation title: Golimumab, a New Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously Every Four Weeks in Patients With Active Rheumatoid Arthritis Despite Methotrexate: Week 24 Results of the Randomized, Double-Blind, Placebo-Controlled, GO-FORWARD Study. Abstract THU0156.]
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