The controlled, randomised trial enrolled 152 adult subjects with chronic gout refractory to oral urate-lowering therapy, irrespective of chronic kidney disease (CKD) status.
They were randomised into a 2:1 ratio to receive Krystexxa plus methotrexate, an immunomodulator or Krystexxa plus placebo for 52 weeks.
Subjects who received Krystexxa plus methotrexate experienced an increased reduction in systolic blood pressure at week 24 with effects sustaining for more than 52 weeks versus Krystexxa plus placebo.
Subjects without pre-treatment CKD had a drastic drop in blood pressure after week 24 with variations lasting through week 52 versus those with pre-treatment CKD.
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.
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“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 is approved by the Food and Drug Administration to treat uncontrolled gout in adults.
Subsequently, the FDA granted approval for the expanded indication of Krystexxa to be used along with methotrexate.
In September this year, the company reported findings from a Phase Ib part of the CodeBreaK 101 trial of LUMAKRAS (sotorasib) plus carboplatin and pemetrexed to treat KRAS G12C-mutated advanced non-small cell lung cancer.