Retreatment with Pegloticase after a Gap in Therapy in Patients with Gout: A Report of Four Cases

Abstract

IntroductionPegloticase, a potent uricolytic biologic enzyme, has been shown to be an effective therapeutic option in patients with uncontrolled gout. However, there are limited data on clinical response after a gap in therapy and retreatment with pegloticase.Case SeriesThis report describes four patients with chronic gout who were successfully managed with pegloticase and were retreated following a gap in therapy. Patient charts from a practice-based rheumatology clinic were retrospectively analyzed; four male patients, aged 70–75 years, with chronic gout and a more than 4-week gap in pegloticase therapy were reviewed. Before pegloticase treatment, patients had received allopurinol or febuxostat, but they continued exhibiting symptoms, including visible tophi and serum uric acid (SUA) levels of 5.2–10.2 mg/dL (309–607 μmol/L), despite oral urate-lowering therapy. The first pegloticase treatment (8-mg infusion every 2 weeks) lasted 22–124 weeks. Pegloticase resolved tophi and improved SUA to below 1.5 mg/dL (less than 89 μmol/L); however, patients discontinued pegloticase because of symptom resolution, poor adherence, or personal reasons. Following treatment gaps (12–156 weeks), symptoms and SUA levels increased and patients were retreated with pegloticase (4–147 weeks). In three of four patients, reinitiating pegloticase lowered SUA levels to below 1.0 mg/dL (less than 59 μmol/L) and resolved symptoms. One patient experienced an infusion reaction and discontinued; no infusion reactions, gout flares, or adverse events occurred among the other three patients.ConclusionRetreatment with pegloticase after a gap in therapy appears to be an effective and tolerated option in prior responders.FundingHorizon Pharma.

Sustained Response to Pegloticase Without Infusion Reactions Despite Multiple Lapses in Treatment in Patient With Severe Tophaceous Gout

“…A subanalysis of 2 randomized clinical trials performed by Baraf et al 10 demonstrated that 71% (10/14) patients maintained a urate-lowering response upon retreatment, even after more than a 4-week gap between infusions. 10,11 Further data analysis did not show any correlation between the length of treatment gap and urate-lowering effects. A case report series written by Morton et al 11 describes 4 patients who received treatment with pegloticase who were subsequently retreated after a 12-to 156-week gap in therapy.…”

“…At this time, little is known about reinitiation of pegloticase after gaps in treatment. A subanalysis of 2 randomized clinical trials performed by Baraf et al 10 demonstrated that 71% (10/14) patients maintained a urate-lowering response upon retreatment, even after more than a 4-week gap between infusions 10,11 . Further data analysis did not show any correlation between the length of treatment gap and urate-lowering effects.…”

“…Further data analysis did not show any correlation between the length of treatment gap and urate-lowering effects. A case report series written by Morton et al 11 describes 4 patients who received treatment with pegloticase who were subsequently retreated after a 12- to 156-week gap in therapy. Two of the 4 patients were initially taken off treatment after they had resolution of symptoms, whereas 2 were stopped due to patient preference.…”