FDA Approves Pegloticase (Krystexxa) for Refractory Gout

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Good news for patients with gout. The US Food and Drug Administration (FDA) has just approved a new agent, pegloticase (Krystexxa) for gout patients who are refractory to conventional therapy.

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.

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