Phase 3 studies show golimumab significantly improved signs and symptoms of rheumatoid... (golimumab group were classified as DAS28...)

Phase 3 studies show golimumab significantly improved signs and symptoms of rheumatoid arthritis

Date:6/10/2008

golimumab group were classified as DAS28 (CRP) responders, and 38 percent achieved DAS 28 remission, compared with 61 percent and 28 percent of patients receiving placebo and MTX, respectively (p<0.001 for responders and p=0.031 for remission).

"We are encouraged by the findings of both of these Phase 3 studies," said Robert J. Spiegel, M.D., chief medical officer, Schering-Plough Research Institute. "Golimumab holds great promise as an anti-TNF therapy for patients who may benefit from monthly subcutaneous injections for RA and related rheumatic diseases."

In March 2008, Centocor Inc. and Schering-Plough Corporation (NYSE: SGP) announced that a Marketing Authorization Application (MAA) had been submitted to the European Medicines Agency requesting the approval of golimumab as a monthly subcutaneous treatment for adults with RA, psoriatic arthritis and ankylosing spondylitis. The initial submission and Phase 3 development programs are unprecedented among anti-TNF-alpha therapies, as they mark the first time that an MAA has been proposed for review inclusive of three unique disease states. Golimumab, Centocor's and Schering-Plough's next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every four-week subcutaneous injection and an intravenous (IV) infusion therapy.

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Contact: Brian Kenney
bkenney1@cntus.jnj.com
215-620-0111
Centocor, Inc.
Source:Eurekalert

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Phase 3 studies show golimumab significantly improved signs and symptoms of rheumatoid...(golimumab group were classified as DAS28...)