Centocor, Schering-Plough arthritis drug golimumab more effective than placebo, phase 2 study says

By Angela McDaniels

Seattle, Nov. 16 - Centocor Inc. and Schering-Plough said a phase 2 study assessing the safety and efficacy of golimumab achieved its primary endpoint: more than 60% of patients treated with golimumab and MTX (methotrexate) experienced at least 20% improvement in arthritis symptoms at week 16 compared with 37% of placebo-treated patients.

Additionally, 25% of patients receiving golimumab and MTX achieved remission as evaluated by a Disease Activity Score of 28, the companies said.

Adults with active rheumatoid arthritis for at least three months' duration despite MTX therapy

were randomized to one of five treatment groups: placebo every two weeks, 50 milligrams of golimumab every two weeks, 100 milligrams of golimumab every two weeks, 50 milligrams of golimumab every four weeks or 100 milligrams of golimumab every four weeks. All patients received stable doses of MTX of 10 milligrams or more a week.

Data from the study showed that significantly more patients in all groups receiving injections of golimumab plus MTX achieved a marked improvement in arthritis symptoms versus patients receiving placebo plus MTX, the companies said.

The findings will be presented this week at the American College of Rheumatology 2005 Annual Scientific Meeting in San Diego.

Golimumab, developed by both companies, is a human anti-TNF-alpha IgG1 monoclonal antibody that targets and neutralizes both the soluble and the membrane-bound form of TNF-alpha. It is currently being investigated for administration by either subcutaneous injection or intravenous infusion.

Rheumatoid arthritis is a chronic, progressive disease and research demonstrates that a critical therapeutic window exists within the first two years of disease onset when the rate of progression of the disease can be "reset," the companies said.

Centocor is a Horsham, Pa.-based manufacturer of biomedicines and subsidiary of Johnson & Johnson.

Kenilworth, N.J.-based Schering-Plough is a health care company that develops prescription, consumer and animal health products.

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