Phase 3 studies show golimumab significantly improved signs and symptoms of rheumatoid...( PARIS France - 11 June 2008 Finding...)

PARIS, France - 11 June 2008 Findings from two new Phase 3 studies showed that patients receiving every four-week subcutaneous injections of golimumab (CNTO 148) 50 mg and 100 mg and weekly methotrexate (MTX) experienced significant improvements in the signs and symptoms of rheumatoid arthritis (RA) as well as in physical function and disease activity, with some patients achieving remission as measured by Disease Activity Score (DAS28). Findings from two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies showed the efficacy of golimumab in two important populations MTX-naive patients and patients with active RA despite ongoing treatment with MTX. These data were presented at the European League Against Rheumatism (EULAR) Annual Congress of Rheumatology. Golimumab is currently in the most comprehensive initial Phase 3 development program to date for an anti-tumor necrosis factor (TNF)-alpha biologic therapy with ongoing studies for the treatment of RA, psoriatic arthritis and ankylosing spondylitis.

In the study, GOlimumab FOR subjects With Active RA Despite MTX (GO-FORWARD), both the 50 mg and 100 mg doses of golimumab were studied in patients whose disease was active despite ongoing treatment with MTX. At week 14, 55 percent of patients receiving golimumab 50 mg plus MTX and 56 percent receiving golimumab 100 mg plus MTX achieved at least 20 percent improvement in signs and symptoms of RA (ACR 20), compared to 33 percent of patients receiving placebo and MTX (p<0.01 and p<0.001, respectively). Improvements were seen as early as first clinical assessment, which was four weeks after the first golimumab injection, and generally continued to improve over time.

"The data in this study demonstrate that golimumab is beneficial in improving numerous disease parameters, including inducing remission, in patients whose disease was active despite ongoing treatment with methotrexate," said Edward Keystone, M.D., FRCPC, dir
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