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

ed significant improvements in physical function, as measured by the Health Assessment Questionnaire (HAQ). HAQ assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and other activities of daily living).

At week 24, the proportion of patients experiencing clinically relevant improvement (increase in HAQ score of at least 0.25 from baseline) was significantly greater for golimumab-treated patients compared with those receiving placebo. More than half of patients in the combined golimumab group (52 percent) achieved the measure, compared with 34 percent of placebo-treated patients (P < 0.001). Also at week 24, patients receiving golimumab experienced a mean improvement in HAQ of 0.27 +/- 0.51, compared with an improvement of 0.05 +/- 0.51 among patients receiving placebo (P < 0.001). Importantly, among patients whose prior anti-TNF therapy was discontinued due to lack of efficacy, golimumab-treated patients experienced a mean improvement of 0.23 +/- 0.50 in HAQ, compared with an average improvement of 0.06 +/- 0.51 for patients receiving placebo (P < 0.05).

At week 24, the combined golimumab group also experienced significantly greater mean improvement in fatigue, 6.8 +/- 11.4, compared with an improvement of 3.0 +/- 9.7 among patients treated with placebo (P < 0.001). Patients were evaluated with the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), a 13-item questionnaire that assesses self-reported fatigue and its impact on daily activities and function.

Improvements Seen in Patients Previously Treated with Methotrexate

A second Phase 3 study also presented at ACR evaluated 50 mg and 100 mg doses of golimumab in RA patients who had active RA and were previously treated with methotrexate. In GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD), patients also indicated significant improvement in f
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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
2. Medarex Receives Milestone Payment for Submission of Regulatory Application Requesting Approval of Golimumab (CNTO 148) in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
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