Post hoc analysis of two trials of Krystexxa show reductions in blood pressure in gout patients.- HorizonPharma.

Horizon Pharma plc presented a post-hoc analysis of data from two randomized, placebo-controlled clinical trials of Krystexxa (pegloticase injection) in adults living with chronic gout refractory to conventional therapies, also known as uncontrolled gout. In the post-hoc analysis, nearly two-thirds of patients who were serum uric acid (sUA) responders to Krystexxa experienced reductions in mean arterial blood pressure (MAP) throughout the trials. The analysis (Pegloticase, a Mammalian Uricase, Significantly Decreases Mean Arterial Blood Pressure in Patients with Chronic Gout; abstract FR-PO582) was presented at the American Society of Nephrology (ASN) Kidney Week 2017, Oct. 31 – Nov. 5, in New Orleans.

Summary of Study Results- This post-hoc analysis included data from two pivotal, six-month clinical trials in which patients were randomized to treatment with Krystexxa 8 mg every two weeks or placebo. A total of 29 patients who received Krystexxa every two weeks were characterized as sUA responders by the prespecified primary endpoint. MAP for this responder group at baseline was 94.9 ­+ 9.6 mm Hg. An assessment of the 29 sUA responders indicated a reduction in MAP throughout the six-month trials and was noted within two weeks of the first Krystexxa dose. Of the 29 sUA responders, 18 (62.1 percent) had decreases in MAP throughout the trials. Blood pressure reductions seen in sUA responders were independent of changes in renal function (as measured by estimated glomerular filtration rate, or eGFR).

There were no significant differences in baseline age, gender, race, body mass index (BMI), history of hypertension, gout duration, MAP, baseline sUA, cholesterol, eGFR or urinary uric acid/creatinine ratio between those who experienced persistent decreases in MAP and those who did not. There were no significant changes in eGFR in sUA responders and no significant correlation between changes from baseline MAP and eGFR in these patients. While the studies utilized for this analysis were not designed to evaluate change in MAP as a clinical endpoint, these data support further investigation of Krystexxa in blood pressure reduction.