Phase 3 Studies of ACZ885 for Gouty Arthritis

Novartis announced results of two Phase 3 studies of ACZ885 (canakinumab) for the treatment of severe gouty arthritis. These randomized, multicenter, double-blind, double-dummy, active-controlled studies analyzed a subgroup of patients (n=228 and n=226) who had ≥3 gouty arthritis attacks in the previous 12 months and were either unresponsive or intolerant to common therapies such as NSAIDs or colchicine, or these treatments were contraindicated. Both studies had the same two primary endpoints of pain intensity at 72 hours post-dose and time to the first new gouty arthritis attack.

The data reported at 72 hours after treatment showed that ACZ885 reduced pain by an additional 11.4 millimeters (mm) (P=0.0005) in one study and 9.8mm in the other (P=0.0018), compared to the injectable steroid, triamcinolone acetonide (TA).  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).

ACZ885 is a fully human monoclonal antibody that inhibits interleukin-1 beta (IL-1 beta). Excessive production of IL-1 beta plays a major role in many inflammatory diseases, including gouty arthritis. ACZ885 works by neutralizing IL-1 beta for a sustained period of time, therefore inhibiting inflammation.

For more information call (800) 693-9993 or visit www.novartis.com.