SAN DIEGO, Calif., November 16, 2005 -- Results from a Phase 2 rheumatoid arthritis (RA) study assessing the safety and efficacy of golimumab (CNTO 148), a fully-human anti-TNF-alpha therapy, showed that it achieved the primary endpoint of the study. In this dose-ranging trial, more than 60 percent of patients with moderately to severely active RA treated with golimumab and methotrexate (MTX) experienced at least 20 percent improvement in arthritis symptoms at week 16. Additionally, one-quarter of patients receiving golimumab and MTX achieved remission as evaluated by Disease Activity Score 28 (DAS28). These findings will be presented this week at the American College of Rheumatology 2005 Annual Scientific Meeting.
"When treating a debilitating disease like RA, it is important to have several treatment options, and we are encouraged by the safety and efficacy data we have seen thus far for golimumab," said Jonathan Kay, MD, Director, Clinical Trials, Rheumatology Unit, Massachusetts General Hospital, Associate Clinical Professor of Medicine, Harvard University School of Medicine and lead study investigator.
Golimumab, developed by Centocor, Inc. and Schering-Plough, is a fully-human anti-TNF-alpha IgG1 monoclonal antibody that targets and neutralizes both the soluble and the membrane-bound form of TNF-alpha. Golimumab is currently being investigated for administration by either subcutaneous (SC) injection or intravenous (IV) infusion.
Data from the study showed that significantly more patients in all groups receiving SC injections of golimumab plus MTX achieved ACR 50 response (marked improvement in arthritis symptoms according to the American College of Rheumatology scoring criteria) versus patients receiving placebo plus MTX. Adults with active RA for at least three months' duration despite MTX therapy were randomized to one of five treatment groups: placebo every two weeks or golimumab 50 or 100 mg every two weeks or every four weePage: 1 2 3 4 Related biology news :1
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