( ed improvement in arthritissymptoms ac...)Anti-TNF Golimumab Continues to Show Promise in Phase II Rheumatoid,Arthritis Study,Health

ed improvement in arthritis symptoms according to the American College of Rheumatology scoring criteria) at Week 16 compared with patients treated with placebo plus MTX group. Adults with active RA for at least three months' duration despite methotrexate therapy were randomized to one of five treatment groups: placebo or golimumab 50 or 100 mg every two weeks or every four weeks. All patients received stable doses of methotrexate of at least 10 mg/week. Moreover, through week 52, fewer patients discontinued therapy in the combined golimumab group (21 percent) than in the placebo/infliximab (control) group (40 percent). There was no clear dose response; through week 52, the reduction in the signs and symptoms of RA observed at week 16 was maintained for all doses.

“The fact that golimumab maintained its efficacy over the course of a full year is very encouraging,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. “Schering-Plough is a leader in bringing forward innovative therapies, such as Golimumab, to patients, helping physicians alleviate their suffering. We are committed to further investigating golimumab as an effective treatment for these patients.”

About the Study

This Phase II, randomized, double-blind, placebo-controlled, dose-ranging trial involved 172 patients with active rheumatoid arthritis for at least three months' duration despite methotrexate therapy. Patients were randomized to one of five treatment groups and beginning at week 20, patients randomized to the placebo group received infliximab (3 mg/kg) at weeks 20, 22, 28, 36, and 44. Patients receiving golimumab continued at their assigned dose (50 or 100 mg) every four weeks from week 20 to week 48.

The Disease Activity Score 28 (DAS28) was developed to measure the disease activity in patients with Rheumatoid Arthritis and has been validated for its use in clinical
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