Phase 3 Data Show New Anti-TNF, Golimumab, Significantly Improved Arthritis, Skin and Nail Manifestations in Patients with Psoriatic...( Golimumab Achieved Primary and Majo...),Health

Golimumab Achieved Primary and Major Secondary Endpoints in the Largest

Phase 3 Biologic Trial Completed to Date in Psoriatic Arthritis

BOSTON, Nov. 7 /PRNewswire/ -- Patients with active psoriatic arthritis receiving monthly subcutaneous (SC) injections of golimumab (CNTO 148) experienced significant and sustained improvements in the joint and skin manifestations of the disease, according to findings from the largest Phase 3 biologic study ever completed in subjects with psoriatic arthritis. Findings presented at the American College of Rheumatology (ACR) Annual Scientific Meeting showed that at week 14 of the 405-patient study in subjects with active psoriatic arthritis, 51 percent of patients receiving golimumab 50 mg and 45 percent of patients receiving golimumab 100 mg experienced at least 20 percent improvement in arthritis signs and symptoms (ACR 20) compared with 9 percent of patients receiving placebo (P < 0.001 for both comparisons). Golimumab-treated patients maintained significant improvements in arthritis through week 24 and also showed substantial and sustained improvements in skin and nail psoriatic disease (as measured by a 75 percent reduction in Psoriasis Area and Severity Index [PASI 75] in patients with baseline body surface area with psoriasis of at least three percent, and the Nail Psoriasis Severity Index [NAPSI]).

Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF- alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy.

"The availability of treatments that target TNF-alpha have dramatically changed rheumatologists' ap
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