Two Novartis ACZ885 Phase III trial data in severe gouty arthritis to be presented at EULAR 2011

Novartis announced 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. 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. 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).

Gouty arthritis, commonly referred to as gout, is a serious, chronic and progressive inflammatory disease that affects up to 8.3 million Americans. The most common form of inflammatory arthritis in adults, gouty arthritis is estimated to be five times more prevalent than rheumatoid arthritis in the US.  

"We are very excited about these results, which indicate that ACZ885 may become a significant new alternative for gouty arthritis patients where many standard anti-inflammatory treatments are inadequate or inappropriate," said David Epstein, Head of the Pharmaceuticals Division of Novartis. "Novartis is committed to meeting this unmet medical need and to further investigating the potential of ACZ885 in a number of other conditions where interleukin-1 beta may play a role."