Novartis reported positive data from two Phase III studies evaluating its fully human monoclonal antibody canakinumab (ACZ885) in the treatment of severe gouty arthritis. The combined data showed that in comparison with treatment using the injectable steroid triamcinolone acetonide (TA), therapy using subcutaneously injected canakinumab provided better pain relief and reduced the risk of new attacks by up to 68%.
Regulatory filings for the use of ACZ885 in gouty arthritis were filed in the EU in 2010, and in the U.S. earlier in 2011. ACZ885 is already approved in over 45 countries including the EU, U.S., and Switzerland, under the brand name Ilaris®, as a treatment for the inflammatory disorder cryopyrin-associated periodic syndromes, in adults and children. The antibody is separately being investigated in other inflammatory disorders including systemic juvenile idiopathic arthritis, cardiovascular disease, and diabetes. Sales of Ilaris for the CAPS indication were $11 million in the first quarter of 2011.
The two reported 12-week Phase III gouty arthritis trials involved a total of over 450 affected patients for whom standard anti-inflammatory treatments, nonsteroidal anti-inflammatory drugs, or colchicine were inadequate or inappropriate. The primary endpoints were pain intensity at 72 hours post-dose, and time to first new gouty attack. Pain intensity scores were measured according to the Visual Analog Scale.
In one of the studies patients treated using the IL-1beta inhibitor canakinumab demonstrated significantly lower mean pain scores from baseline compared with those receiving TA. Pain intensity at 72 hours was 29.1 mm for canakinumab-treated patients, and 39.5 mm for the TA-treated cohort. The equivalent 72-hour pain scores in the second study were similarly significant, at 22.1 mm for the canakinumab group, and 31.9 m for the TA group.
In the first study, 40 TA-treated patients experienced a new gouty arthritis attack, compared with only 21 patients in the canakinumab cohort. 42 TA-treated patients in the second study experienced a new attack, compared with just 15 patients in the canakinumab group.
“Scientists only recently learned that the root cause of the pain in gouty arthritis is IL-1beta,” comments Professor Alexander So, one of the Phase III studies’ lead investigators, at the department of rheumatology, Centre hospitalier universitaire vaudois. “Through specifically targeting IL-1beta these studies show ACZ885 can effectively treat painful attacks while extending the time to new attacks.”