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New STELARA data show inhibition of joint destruction in active psoriatic arthritis
Date:10/28/2013

San Diego, October 28, 2013 -- New findings from two integrated Phase 3 Janssen Research & Development, LLC (Janssen)-sponsored studies showed treatment with STELARA (ustekinumab) resulted in significantly greater inhibition of structural damage in patients with active psoriatic arthritis compared with placebo. Pre-specified integrated analyses from the PSUMMIT I and II trials showed treatment with either STELARA 45 mg or 90 mg resulted in significantly less change from baseline at week 24 in total psoriatic arthritis modified van der Heijde-Sharp (vdH-S) scores compared with placebo. STELARA-treated patients from the combined data analysis of both trials demonstrated continued inhibition through one year and through two years according to findings from the PSUMMIT I trial. These results are being presented during the 2013 Annual Meeting of the American College of Rheumatology (ACR). STELARA recently received approval from the U.S. Food and Drug Administration (FDA) and approval from the European Commission for the treatment of signs and symptoms in adult patients with active psoriatic arthritis.

"Data from the integrated analysis of the Phase 3 clinical program show the efficacy of the interleukin-12/23 antibody STELARA in inhibiting the progression of structural damage in patients with active psoriatic arthritis," said Iain B. McInnes, PhD, FRCP, Professor of Medicine, and Director of the Institute of Infection, Immunity, and Inflammation, University of Glasgow, Scotland, lead study investigator. "These new findings are significant since impeding further joint damage is an important part of the long-term management of this chronic inflammatory disease."

According to a pre-specified integrated analysis of the two Phase 3 Multicenter, Randomised, Double-blind, Placebo-controlled trials of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis (PSUMMIT I
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Contact: Brian Kenney
BKenney1@its.jnj.com
215-628-7010
Tonic Life Communications USA
Source:Eurekalert

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