What is your approach to using pegloticase in patients with congestive heart failure?

Clinical trial data show developing CHF exacerbation in 2% of patients while on Pegloticase treatment, while real-world data show higher numbers (6.4%), so careful patient selection and stabilization of CHF are necessary before starting treatment, and need close monitoring while receiving treatment.

I would consider Pegloticase in patients who have compensated CHF with careful monitoring.

I am unaware of the real-world data, but very much aware of the phase 3 clinical trial data with pegloticase. The inclusion/exclusion criteria in the two phase 3 trials allowed entry for patients with a history of congestive heart failure, as long as it was compensated/under control. Of the 169 patients that enrolled in these studies and received the drug, 20 patients had a pre-existing history of congestive heart failure. Three of these patients, or 2%, experienced a flare-up of this condition during the 6-month open-label phase of this program. All 3 CHF exacerbations occurred in patients with a history of compensated CHF at enrollment. It is my belief that pegloticase, per se, was not causative in these instances.

Patients with uncontrol...

Yes