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Phase 3 Data Show Intravenous Golimumab Inhibited Radiographic Progression in Patients with Active Rheumatoid Arthritis
Date:11/12/2012

psoriatic arthritis alone or with the medicine methotrexate and active ankylosing spondylitis.

"These Phase 3 data show treatment with intravenous golimumab plus methotrexate induced and maintained improvements in the signs and symptoms of rheumatoid arthritis, and inhibited the progression of structural damage.  Such findings are encouraging for rheumatologists and patients," said Rene Westhovens, M.D., Ph.D., Professor at the Department of Rheumatology, KU Leuven, Belgium, and study investigator. "Through week 52, intravenously administered golimumab showed a consistent benefit-to-risk profile compared with previously reported week 24 data."

In the Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy (GO-FURTHER), patients were randomized to receive I.V. golimumab 2 mg/kg or placebo, via a 30-minute infusion, plus methotrexate at weeks 0, 4 and then every 8 weeks.  Non-responders to placebo at week 16 were crossed over to receive I.V. golimumab, and all remaining patients receiving placebo crossed over at week 24.  Radiographic progression was assessed by the change from baseline in van der Heijde-Sharp (vdH-S) scores, an X-ray measure of joint destruction, including joint erosion and joint space narrowing in which higher scores indicate greater structural damage.  At week 24, patients receiving I.V. golimumab had a mean change (+/- standard deviation) in total vdH-S score of 0.03 (+/-1.90) from baseline, compared with a mean change of 1.09 (+/- 3.19) in the placebo group (P < 0.001).  At week 52, patients who received the 52-week regimen of I.V. golimumab had a mean change of 0.13 (+/- 3.11) from baseline, compared with a mean change of 1.22 (+/- 3.98) in patients who crossed over fr
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SOURCE Janssen Research & Development, LLC
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