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Novartis Data Shows ACZ885 for Severe Gouty Arthritis Provided Better Pain Relief and Reduced Risk of New Attacks by Up to 68% vs. Steroid
Date:5/24/2011

EAST HANOVER, N.J., May 25, 2011 /PRNewswire/ -- Novartis announced today results of two pivotal Phase III trials in patients with severe gouty arthritis, showing that ACZ885 (canakinumab) provided superior pain relief and reduced the risk of suffering new attacks by up to 68% compared to an injectable steroid (triamcinolone acetonide, TA) used to treat gouty arthritis attacks(1,2). ACZ885 is an investigational fully human monoclonal antibody.

The studies involved more than 450 gouty arthritis patients for whom the standard anti-inflammatory therapies, non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine, were inadequate or inappropriate(1,2). Results will be presented for the first time at the 2011 European League Against Rheumatism (EULAR) Congress in London.

"Patients describe gouty arthritis as agonizingly painful," said Naomi Schlesinger, MD, Associate Professor of Medicine, Chief, Division of Rheumatology, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson University Hospital. "This new research demonstrates that ACZ885, which inhibits interleukin-1 beta, effectively treated and extended the time to new gouty arthritis attacks, thus reducing new attacks in gouty arthritis patients for whom many standard therapies were inadequate or inappropriate."

Both trials used an internationally recognized pain scale to measure differences in pain 72 hours after treatment, and found ACZ885 reduced pain by an additional 11.4 millimeters (mm) (p=0.0005) in one study and 9.8 mm in the other (p=0.0018), compared to TA(1). ACZ885 also significantly reduced the risk of suffering a new gouty arthritis attack within three months compared to TA, by 55% in one study (p=0.0014) and 68% in the other (p<0.0001)(2).

Gouty arthritis, commonly referred to as gout, is a serious, chronic and progressive inflammatory disease that affects up to 8.3 million Americans(3,5). The most common form of inflammatory arthritis in adults,
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SOURCE Novartis Pharmaceuticals Corporation
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