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Phase 3 Data Show New Anti-TNF, Golimumab, Significantly Improved Arthritis, Skin and Nail Manifestations in Patients with Psoriatic Arthritis
Date:11/7/2007

nds or feet, are estimated to affect more than one-third of people with psoriatic arthritis. At baseline, 78 percent (placebo group), 75 percent (golimumab 50 mg group) and 79 percent (golimumab 100 mg group) of study subjects presented with enthesitis (at least one tender body enthesitis site) as measured by the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) index modified for Psoriatic Arthritis; 34 percent (placebo group), 34 percent (golimumab 50 mg group) and 34 percent (golimumab 100 mg group) of subjects presented with dactylitis at baseline.

Both golimumab doses were significantly better than placebo in improvement of enthesitis as measured by percent change in the psoriatic arthritis modified MASES Index.

At week 14, the mean improvement in enthesitis was 44 percent among patients receiving golimumab 50 mg and 33 percent among patients receiving golimumab 100 mg, compared with a 19 percent worsening in patients receiving placebo (P < 0.001). At week 24, the mean improvements in enthesitis were 46 percent for patients receiving golimumab 50 mg and 52 percent among patients receiving golimumab 100 mg, compared with a 13 percent worsening in placebo patients (P < 0.001). The golimumab 100 mg dose significantly improved dactylitis measured by percent change in dactylitis score compared with placebo at week 14 (66 percent versus 5 percent; P = 0.009) and at week 24 (82 percent versus 28 percent; P < 0.001). There was a trend towards improvement in dactylitis for 50 mg golimumab dose at week 14 and 24 but the comparisons with placebo did not reach statistical significance.

In addition to improvements in joint symptoms, a substantial proportion of golimumab-treated patients experienced significant improvement in skin manifestations of the disease. Among a subset of the study population with at least three percent of body surface area involved by psoriasis at baseline, 40 percent and 58 percent of patients receiving golimumab 50 mg and
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SOURCE Centocor Inc.
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