An investigational, fully human monoclonal antibody called ACZ885 (canakinumab) provided better pain relief in treating severe gouty arthritis, and it reduced the risk of new attacks by up to 68% compared with an injectable steroid (triamcinolone acetonide), according to results of 2 phase 3 trials announced by Novartis, the drug?s manufacturer.
An investigational, fully human monoclonal antibody called ACZ885 (canakinumab) provided better pain relief in treating severe gouty arthritis, and it reduced the risk of new attacks by up to 68% compared with an injectable steroid (triamcinolone acetonide, TA), according to results of 2 phase 3 trials announced by Novartis, the drug’s manufacturer.
The studies involved more than 450 patients who met the American College of Rheumatology (ACR) criteria for acute gouty arthritis, had suffered from three or more gouty arthritis attacks in the previous 12 months, and for whom the standard anti-inflammatory therapies, nonsteroidal anti-inflammatory drugs (NSAIDs) or colchicine were inadequate or inappropriate.
Patients were randomly assigned to receive a single dose subcutaneous injection of ACZ885 150 mg or an intramuscular injection of TA 40 mg. In the case of a new attack, patients received a new dose of the same treatment they were randomly assigned to at baseline. Primary end points in both studies were pain intensity at 72 hours post-dose, and time to the first new gouty arthritis attack. The Visual Analog Scale, an internationally recognized pain scale, was used to measure pain in the affected joint.
Results showed that ACZ885 reduced pain by an additional -11.4 mm (P=.0005) in 1 study and by -9.8 mm in the second (P=.0018), compared to TA. ACZ885 also significantly reduced the risk of suffering a new gouty arthritis attack within 3 months by 55% in 1 study (P=.0014) and 68% in the second (P<0.0001), compared to TA.
“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 in a company press release. “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.”
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 United States, Canada, and Switzerland in the first quarter of 2011.