Phase 3 studies show golimumab significantly improved signs and symptoms of rheumatoid...(atients did not receive study drug but w...)

Date:6/10/2008

atients did not receive study drug but were included in the analysis as nonresponders. In the primary analysis of the combined group of patients receiving either golimumab 50 mg or 100 mg in combination with MTX, 38 percent (40 percent receiving 50 mg and 37 percent receiving 100 mg) achieved at least 50 percent improvement in signs and symptoms of RA (ACR 50) through week 24, compared with 29 percent of patients receiving placebo plus MTX (p=0.053 for the combined group, p=0.042 for 50 mg and p=0.177 for 100 mg). When the three patients who did not receive golimumab were excluded in a modified intent-to-treat (mITT) analysis, the results showed that 39 percent of patients in the combined golimumab plus MTX group (41 percent receiving 50 mg and 37 percent receiving 100 mg) achieved ACR 50, compared with 29 percent of patients receiving placebo plus MTX (p=0.049 for the combined group, p=0.038 for 50 mg and p=0.177 for 100 mg). Additionally, 62 percent of patients in the combined golimumab plus MTX group (62 percent for each dose group) achieved ACR 20, compared with 49 percent receiving placebo plus MTX (p=0.011 for the combined group and p=0.028 for each dose group).

"These data show that treatment with golimumab induces an important depth of response, improving multiple aspects of rheumatoid arthritis and leading to significant decreases in disease activity," said Roy Fleischmann, M.D., Clinical Professor, Department of Internal Medicine at the University of Texas Southwestern Medical Center; Chief, Division of Rheumatology at St. Paul University Hospital in Dallas, Texas and lead study investigator. "Golimumab, which is an anti-TNF therapy, is a promising treatment option for multiple patient populations with this chronic and potentially debilitating inflammatory disease."

Also at week 24, patients receiving golimumab plus MTX experienced improvements in disease activity as measured by DAS28. Seventy-six percent of patients in the combined
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Contact: Brian Kenney bkenney1@cntus.jnj.com 215-620-0111 Centocor, Inc. Source:Eurekalert

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