New Phase II study in gout patients shows Novartis ACZ885 prevented acute flares better than standard anti-inflammatory therapy
New phase II data demonstrate that the human monoclonal antibody ACZ885 (also known as canakinumab) provided highly statistically significant risk reduction of acute flares in gout patients initiating uric acid lowering therapy (UALT) compared to the anti-inflammatory standard of care (colchicine).
In this six month Phase II study, canakinumab significantly reduced the rate of flares by 48% to 75% compared to colchicine. Similarly, canakinumab reduced the risk of developing at least one flare by 61% to 80% vs. colchicine p. Preliminary results were presented at the annual European League Against Rheumatism (EULAR) meeting in Rome, Italy.
"Gout patients frequently experience painful flares with debilitating consequences on their quality of life because current treatment strategies are not well tolerated and have limited efficacy," said Trevor Mundel, MD, Head of Global Development at Novartis Pharma AG. "These new results reinforce previous positive data suggesting that canakinumab, if approved, can more effectively address the unmet needs of patients to both treat and prevent acute gout flares."
These new findings reinforce data from another Phase II study that involved patients with acute gout attacks who are intolerant, contraindicated or not responsive to common anti-inflammatory therapies. Data from this study showed that canakinumab provided better pain relief and reduced risk of acute flares by 94% versus a potent injectable corticosteroid (triamcinolone acetonide. Canakinumab is in Phase III development for the treatment and prevention of acute gout attacks and submission is planned later this year in the EU and US.
The Phase II data presented at EULAR is a 24-week, multi-center, double-blind study and involved 432 gout patients ranging from 20 to 70 years in age who were initiating UALT (allopurinol). The study explored a number of doses of canakinumab versus colchicine and the primary endpoint sought to determine the dose of canakinumab that provides the same efficacy to the dose of the anti-inflammatory colchicine (0.5 mg) with respect to the mean number of gout flares experienced by patients during 16 weeks. All canakinumab tested doses were better than colchicine. Secondary endpoints included among others the number of patients with flares after 16 weeks and safety assessment at 24 weeks.
Canakinumab was generally well tolerated with similar incidence of adverse events across all treatment groups. The most frequent adverse events in all treatment groups were headache, arthralgia and hypertension. Infections (predominantly upper respiratory tract infection and nasopharyngitis) were slightly more frequent in the canakinumab groups (15.1% to 20.4%) than in the colchicine group (12.0%).
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