Novartis’ new phase II results show that the new therapy ACZ885 (canakinumab) is significantly more effective than an injectable corticosteroid at reducing pain and preventing recurrent attacks or ‘flares’ in patients with gout.
ACZ885 is a human monoclonal antibody which blocks the action of the inflammatory protein interleukin-1 beta (IL-1 beta). It has been approved under the brand name Ilaris in a number of countries for treating cryopyrin-associated periodic syndrome (CAPS). ACZ885 provides a potent and selective blockade of IL-1 beta for a sustained period, neutralising and reducing inflammation.
The study met its primary endpoint by showing that during acute gout flares, ACZ885 reduced pain faster and more effectively than the injectable corticosteroid triamcinolone acetonide.
Reportedly, at the end of the eight-week study, the risk of flare recurrence was 94% less for patients on ACZ885 than on the steroid. The results were presented at the American College of Rheumatology (ACR) Annual Scientific Meeting in Philadelphia, US.
The study was a randomised, single-blind, double-dummy phase II study involving 200 patients aged 18-80 years old with chronic gout, designed to assess the efficacy and optimum dose of ACZ885 in patients for whom current treatments (colchicine and/or NSAIDs) are ineffective or contraindicated.
The results showed that patients given ACZ885 150mg experienced faster and more effective pain relief than those given the corticosteroid triamcinolone acetonide from 24 hours up to seven days.
Trevor Mundel, head of global development at Novartis, said: “The latest data are encouraging for patients with hard-to-treat gout in whom the disease is not effectively managed, resulting in chronic pain. These findings also reinforce the potential of ACZ885 in a number of inflammatory diseases where IL-1 beta plays a key role.”