The approval was based on data from 2 replicate, multicenter, randomized, double-blind, 6-month studies which randomized 212 patients with baseline serum uric acid levels of 8 mg/dl or greater to receive either 8mg pegloticase every 2 weeks or 4 weeks or placebo.
As a prophylaxis for gout flares, all patients received nonsteroidal anti-inflammatory drugs and/or colchicine.
Results from 2 studies indicated that 38%-47% of patients receiving 8mg of pegloticase on a bimonthly basis achieved plasma uric acid levels of less than 6 mg/dl (normal level) for at least 80% of the time during month 3 and month 6, compared with 0% of those given placebo.
The investigators also evaluated the effect of pegloticase therapy on tophi (deposit of urate crystals) which were present in 71% of patients. The results showed that 45% of patients receiving bimonthly peloticase achieved a complete response (defined as 100% resolution of at least 1 target tophus, with no single tophus showing progression and no new tophi appearing) at month 6.
Despite premedication, bimonthly pegloticase therapy was associated with glout flares (77%) and infusion reaction (28%). Nausea (12%), contusion/infusion reactions (11%) and nasopharyngitis (7%) were also reported as common adverse effects.
This product should be available in the US by the end of this year and rest of the world by next year.
Please visit healthreason.com for more health related articles.