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Golimumab Phase 3 Data Show Significant Improvement In Physical Function In Patients with Rheumatoid Arthritis
Date:10/27/2008

atigue. At week 24, the mean improvement in FACIT-F was 7.2 +/- 8.6 in the combined golimumab group, compared with an improvement of 2.2 +/- 9.5 among patients receiving methotrexate alone (P < 0.001).

According to the Arthritis Foundation, in addition to joint pain and swelling, RA may make daily functioning difficult and is frequently associated with fatigue. "Patients with RA often say that fatigue is one of their most frustrating symptoms because it makes it difficult for them to participate in work or social activities," said Mark Genovese, M.D., professor of medicine at Stanford University School of Medicine, and lead study investigator. "A reduction in fatigue would represent a tremendous benefit and significantly impact the lives of patients with this disease."

Through week 24, patients in both dose groups receiving golimumab plus methotrexate experienced significant improvement in physical function, compared with patients receiving methotrexate alone. At 24 weeks, 70 percent of those receiving golimumab plus methotrexate experienced a clinically relevant improvement in physical function, compared with 39 percent of patients receiving methotrexate alone (P < 0.0001). Also at week 24, the combined golimumab group achieved a mean improvement in HAQ of 0.46 +/- 0.53, compared with an improvement of 0.13 +/- 0.58 among patients receiving methotrexate alone (P < 0.001).

Patients treated with golimumab also experienced significant improvement in HRQOL, as assessed by the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the Short form (SF)-36 questionnaire. In the combined golimumab plus methotrexate group, the mean improvement in PCS at week 14 was 7.7 +/- 8.1, compared with an improvement of 2.5 +/- 8.1 in the group receiving methotrexate alone (P < 0.001). Patients in the combined group also experienced a mean improvement in MCS of 3.1 +/- 10.8 at week 24, compared with 0.8 +/- 9.7 among patients receiving methot
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SOURCE Centocor
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1. Centocor, Inc. and Schering-Plough Submit Application Requesting Approval of Golimumab in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
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