BioSpace has reported on the results of two Phase III studies of canakinumab in the treatment of severe gouty arthritis, which are due for presentation at the 2011 European League Against Rheumatism (EULAR) Congress.

The two Phase III, randomised, double-blind studies included 228 and 226 patients meeting the American College of Rheumatology (ACR) criteria for acute gouty arthritis, who had suffered from ≥3 gouty arthritis attacks in the previous 12 months and were either unresponsive or intolerant to standard therapies (e.g.  NSAIDs, colchicine), or these treatments were contraindicated. They were randomised to treatment with canakinumab (150mg via SC injection) or triamcinolone acetonide (TA; 40mg IM injection); this was repeated in the case of a new attack.  The primary endpoints were pain intensity at 72 hours post-dose (measured according to the Visual Analogue Scale [VAS]); and time to the first new gouty arthritis attack. 

The main findings reported are as follows:

• Patients randomised to canakinumab had a greater reduction in pain measured by VAS than those randomised to TA – the difference in the reduction seen with the two was 11.4 mm (p=0.0005) in one study and 9.8mm in the other (p=0.0018)

• The number of patients with new attacks across both studies was reduced with canakinumab: such was experienced by 40 vs. 21 patients, respectively, in the first study (p=0.0061) and by 42 vs. 15 patients, respectively, in the second (p=0.0001).

Canakinumab (Ilaris®) is a fully human monoclonal antibody that inhibits interleukin-1 beta.  It is currently licensed in the UK for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS).  Regulatory filings for the use of canakinumab in gouty arthritis patients with limited treatment options were submitted in the EU in 2010 and in the US, Canada and Switzerland in the first quarter of 2011.