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Data From Two Phase 3 Studies Show Anti-TNF Golimumab Significantly Improved Signs and Symptoms of Rheumatoid Arthritis
Date:6/11/2008

ab was generally well-tolerated in RA patients. Through week 16, 61 percent, 63 percent, 69 percent and 70 percent of patients receiving placebo plus MTX, golimumab 100 mg plus placebo, golimumab 50 mg plus MTX and golimumab 100 mg plus MTX, respectively, reported at least one adverse event (AE). Three patients participating in the study developed malignancies: one patient taking golimumab 100 mg plus MTX developed breast cancer, one patient taking golimumab 100 mg plus placebo developed Bowen's disease and one patient taking placebo plus MTX developed basal cell carcinoma. There were no reports of opportunistic infection or tuberculosis.

About the GO-BEFORE Trial

GO-BEFORE, a Phase 3, multi-center, double-blind, placebo controlled study included 637 MTX-naive adults with RA. Patients with active RA who had more than four tender and swollen joints were included in the multicenter study. Adult patients were randomly assigned into four groups to receive placebo every four weeks plus MTX 20 mg per week (Group 1), golimumab 100 mg every four weeks plus placebo every week (Group 2), golimumab 50 mg every four weeks plus MTX 20 mg per week (Group 3), or golimumab 100 mg every four weeks plus MTX 20 mg per week (Group 4).

AEs were generally similar across the four patient groups. Through week 24, serious infections were reported in 2 percent, 1 percent, 1 percent and 4 percent of Groups 1-4, respectively. Four patients reported malignancies during the study: two patients from Group 1 and one patient each from Groups 3 and 4. There were also two deaths during the study -- one patient in Group 3 committed suicide, and one patient from Group 4 died from cardiac arrest following a surgical procedure. Overall, serious AEs were reported in 7 percent, 3 percent, 6 percent and 6 percent of patients in Groups 1-4, respectively.

Anti-TNF therapies have been associated with serious and sometimes fatal risks, including the risk of tuberculosis and other ser
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SOURCE Centocor
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