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Infusion-related reactions common to pegloticase gout trial dropouts
Most patients with gout who dropped out of a random control trial or an open-label extension trial of pegloticase cited infusion-related reactions as the cause of discontinuation.
The researchers looked at data from random controlled trials and an open-label extension trial and explored the data in several ways. Overall, 151 patients who participated in the initial random controlled trial of 225 patients opted to enter an open-label extension trial. Patients had either not responded previously or were intolerant of allopurinol.
During the phase 3 trials, 45% of 208 patients treated with pegloticase reported infusion-related reactions compared to 5% of the placebo enrollees. During the first infusion, 5% of the incidents occurred.
In a pooled study of the phase 3 and open-label extension trials, chest discomfort was most commonly reported, followed by flushing, dyspnea, back pain, and hyperhidrosis, nausea and erythema. Other symptoms included uticaria, chest pain, pruritus, rash, muscle spasms, headache and others.
Clusters of symptom constellations were seen in some patients, which included stridor, wheezing perioral or lingual edema or hemodynamic instability, with or without urticaria. Based on FDA criteria, 14 cases of anaphylaxis occurred among 273 patients enrolled in phase 2 and phase 3 trials, but no reports from investigators included anaphylaxis.
All patients achieved serum uric acid levels less than 6 mg/dL, the primary efficacy endpoint, in the first 24 hours after infusion, but did not necessarily maintain those levels. Overall, 42% of patients responded to biweekly treatment after 6 months. Most infusion-related reactions occurred in patients whose serum uric acid levels were greater than 6 mg/dL.
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