Novartis AG's new gout therapy drug gives patients better pain relief and significantly cuts the risk of new attacks say two late stage studies. The studies show that more than 450 patients taking Ilaris, or ACZ885, had less pain and the risk of new attacks were reduced by up to 68 percent compared to those taking an injectable steroid to treat gouty arthritis attacks, which can last for a week or more.
Gout is severely debilitating disease that affects 1-4 percent of adults. It is a form of arthritis that is characterized by red, hot, inflamed joints. It is the most common form of inflammatory arthritis in adults and can cause chronic disability and joint destruction. Approximately 90% of patients with gout have another co-existing disease, making them ineligible for many of existing gout treatments.
The first study found that ACZ885 reduced pain by an additional 29% on a visual analog scale when compared to TA, and nearly double the number of patients who received TA doses experienced a second gout attack within three months.
The second study expressed similar results, with ACZ885 reducing pain by an additional 31%, with nearly thee times as many patients in the TA group experiencing a second attack within three months.
Novartis had applied for approval of Ilaris in gouty arthritis patients with limited treatment options in the EU last year and in the United States, Canada and Switzerland in the first quarter of this year. The drug is already approved in several countries to treat a rare, inflammatory disorder known as Cryopyrin-Associated Periodic Syndromes (CAPS). The drug maker is also studying Ilaris in other diseases in which IL-1 beta plays a role in causing inflammation, such as cardiovascular disease and diabetes.
This drug, say the developers targets interleukin-1 beta that is the root cause of pain in gouty arthritis. The results of the study will be presented at this year's European League Against Rheumatism (EULAR) Congress in London.