Abstract
Abstract
Background
Pegloticase is an infused pegylated uricase enzyme indicated for the treatment of uncontrolled gout in adults who did not respond to or cannot tolerate oral urate-lowering therapies; pegloticase is administered as 8-mg infusions every 2 weeks (Q2W). However, frequent infusions can create a logistical burden for patients. The phase 4, FORWARD open-label trial (NCT04762498) assessed the efficacy and safety of less frequent and higher dose pegloticase infusions in patients with uncontrolled gout.
Methods
Adults with uncontrolled gout received either 16-mg or 30-mg pegloticase infusions, co-administered with methotrexate, every 4 weeks (Q4W) through the 24-week trial, with an optional extension through Week 48. The primary endpoints were the percentage of responders during Month 6 (those with serum uric acid [sUA]
Results
The percentages of Month 6 responders in the 16-mg cohort (
n
= 25) and 30-mg cohort (
n
= 26) were 68.0% and 73.1%, respectively. The median time to the first sUA level ≥ 6 mg/dL after achieving sUA
Conclusions
The efficacy and safety findings from this study of monthly 16- and 30-mg pegloticase dosing are consistent with results from standard biweekly 8-mg dosing, indicating that a less frequent and higher dosed pegloticase treatment schedule co-administered with methotrexate is feasible for patients with uncontrolled gout.
Trial registration
ClinicalTrials.gov NCT04762498 (registered on 17 February 2021).