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Published on 25 May 2011

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Phase III study shows pain relief for severe gouty arthritis

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  • Two pivotal Phase III studies showed ACZ885 may meet significant unmet need for patients for whom many standard therapies are inadequate or inappropriate
  • Gouty arthritis, commonly referred to as gout, is an inflammatory disease affecting 1–4% of adults, causing severe pain and long-term consequences
  • Regulatory filings for the use of ACZ885 in gouty arthritis patients with limited treatment options have been submitted in the EU, US, Canada and Switzerland

Novartis announced positive 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 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.

“These findings show that ACZ885 may represent an important advance in the treatment of gouty arthritis in sufferers whose disease cannot be appropriately managed with currently available treatments,” said Professor Alexander So, Rheumatology Department, CHUV, Lausanne, Switzerland, and one of the studies’ investigators. “Scientists only recently learned that the root cause of the pain in gouty arthritis is interleukin-1 beta. Through specifically targeting interleukin-1 beta, these studies show ACZ885 can effectively treat painful attacks while extending the time to new attacks.”

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

Gouty arthritis, commonly referred to as gout, is a serious, chronic and progressive inflammatory disease that affects 1–4% of adults. In the UK, an estimated 1.4% of the population suffers from gouty arthritis, while in the US, 3.9% of the population has the condition. Gouty arthritis is the most common form of inflammatory arthritis in adults, with a prevalence comparatively higher than rheumatoid arthritis, which is estimated to affect 0.5–1% of adults.

“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.”

Gouty arthritis attacks occur when the body has a strong inflammatory response to uric acid crystals forming in the affected joint, typically of the toe, foot, ankle or knee. This intense inflammatory response causes the severe pain associated with gouty arthritis attacks, which can last for a week or more. Gouty arthritis may also result in chronic disability and joint destruction.

Treatments currently available to manage the pain and inflammation of gouty arthritis attacks, such as NSAIDs or colchicine, may be inadequate or inappropriate in patients who have coexisting medical problems. This poses a significant unmet treatment need in gouty arthritis. New data presented at EULAR today indicates nearly 90% of gouty arthritis patients in the EU and the US have at least one coexisting disease, a portion of whom may be unable to take these standard anti-inflammatory therapies.

Regulatory filings for the use of ACZ885 in gouty arthritis patients with limited treatment options were submitted in the EU in 2010 and in the US, Canada and Switzerland in the first quarter of 2011.

Novartis



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