Canakinumab Reduces Acute Flares In Gout Patients: Novartis Pharma

Preliminary results of Canakinumab were presented at the annual European League Against Rheumatism (EULAR) meeting in Rome, Italy.

In the six month Phase II study, Canakinumab has 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.

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).

The Phase II trial 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 (0.5mg) 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.

Novartic said that 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.

Canakinumab is approved in the EU, US, Brazil, Canada, Australia and Switzerland for the treatment of adults and children as young as four with cryopyrin-associated periodic syndrome (CAPS), under the brand name Ilaris.

Trevor Mundel, head of global development at Novartis Pharma, said: “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.”

Naomi Schlesinger, department of medicine, University of Medicine and Dentistry of New Jersey, US, said: “These promising data indicate that the blockade of IL-1ß provided by Canakinumab was effective in preventing acute flares for a sustained period of time compared to anti-inflammatory standard of care and may represent a future novel advance in the treatment of debilitating gout attacks.”