The reduction in systolic blood pressure during treatment in the Phase 4 trial was more significant at Week 24 for those receiving Krystexxa with methotrexate compared to those on Krystexxa with placebo
Amgen’s Krystexxa demonstrates blood pressure reduction in uncontrolled gout patients in the MIRROR randomised controlled trial. (Credit: Amgen Inc.)
Amgen has released updated findings from the Phase 4 MIRROR trial, which revealed that Krystexxa (pegloticase) could reduce blood pressure among adults dealing with uncontrolled gout, which is chronic gout resistant to oral urate-lowering treatment.
The effect was observed in individuals both with and without chronic kidney disease (CKD).
In the MIRROR randomised controlled trial, 152 adults were randomly assigned in a 2:1 ratio, with 100 receiving Krystexxa alongside methotrexate and 52 receiving Krystexxa with a placebo for a duration of 52 weeks.
Before treatment, both the patient groups exhibited similar blood pressure levels.
However, the reduction in systolic blood pressure during treatment was more significant at Week 24 for those receiving Krystexxa with methotrexate compared to those on Krystexxa with placebo. This reduction was sustained over the entire 52-week treatment period in the Krystexxa with methotrexate group.
Furthermore, individuals without pre-treatment chronic kidney disease experienced a more notable decline in blood pressure after Week 24 of treatment compared to those with pre-treatment (CKD). These differences in blood pressure reduction persisted through Week 52 of treatment.
Amgen nephrology medical director Brad Marder said: “As we seek to address the overall burden of uncontrolled gout, especially in those with coexisting chronic kidney disease, it is critical to further understand the benefits of treatment.
“Recognising the high prevalence of hypertension among these patients, we’re excited to present data that offers new insight into the potential role of urate reduction with Krystexxa with methotrexate in regulating blood pressure.”
Krystexxa was approved by the US Food and Drug Administration in 2010 as a treatment of chronic gout in adults, who are unresponsive to standard treatments.
In 2022, Krystexxa injection co-administered with methotrexate was approved by the FDA to enable more patients with uncontrolled gout attain a complete response to therapy. The expanded approval was driven by the results of the MIRROR trial.
Amgen added the drug to its portfolio after completing the $27.8bn acquisition of Horizon Therapeutics in October 2023.