Swedish Orphan Biovitrum AB (Sobi) releases the primary efficacy results from the phase 2 study with anakinra in patients with acute gout – the anaGO study.
For the primary endpoint of patient assessed pain intensity in the most affected joint there was a substantial reduction from baseline, both following treatment with anakinra and the comparator triamcinolone. There was a clinically meaningful pain reduction with anakinra of around 50% and in line with expectations of IL-1 blockade in this disease. No statistically significant difference between the two treatments was obtained (primary endpoint). The well-established safety profile of anakinra was confirmed in the study.
Sobi will continue to collect data from the extension phase of the phase 2 study to obtain further data in this patient population where further gout flares will be studied. Sobi plans to meet with the FDA to discuss options for moving anakinra forward into phase 3.
The anaGO study is a randomised, double-blind, active-control, multicentre, efficacy and safety study of two dose levels of subcutaneous anakinra for five days compared to a single dose of intramuscular triamcinolone in the treatment of acute gout. The initial phase of the study for the first gout flare is followed by an extension phase where additional flares occurring in the study population are treated until the last randomised patient has been followed for 1 year. The primary objective was to evaluate the efficacy with respect to patient-assessed pain intensity for up to 72 hours after initiation of dosing in the treatment of the first flare. Secondary endpoints included additional measures of efficacy as well as safety and tolerability.
The study randomised 165 patients for whom conventional therapy with NSAIDs and colchicine was contraindicated, not tolerated, or did not provide an adequate response. The patients were randomised to anakinra 100 mg/day, anakinra 200 mg/day, or one injection of triamcinolone 40 mg, in equally sized groups.