Horizon announced data from four new analyses evaluating Krystexxa (pegloticase) in patients with chronic gout. Findings were presented at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain.
One study retrospectively analyzed data from two 6-month, randomized clinical trials that evaluated Krystexxa in patients with and without clinically apparent tophi. Both patient groups experienced significant clinical benefit, improvement in tender or swollen joints, and quality of life as well as a reduction in flares over the treatment period.
At 6 months, patients with clinically apparent tophi had significant reductions in serum uric acid (P<0.0001), flares (P<0.0001), Patient Global Assessment (PGA; P<0.0001), tender and swollen joints (P<0.0001 for both), the Health Assessment Questionnaire-Disability Index (HAQ-DI; P=0.02), and Bodily Pain from the SF-36 item (P<0.0001).
Patients without clinically apparent tophi also had significant reductions in serum uric acid (P<0.0001), flares (P=0.003), PGA (P=0.009), tender joints (P=0.01), swollen joints (P=0.003), the Arthritis-Specific Health Index (ASHI; P=0.0001), and SF-36 (P=0.03).
A different retrospective analysis showed that Krystexxa quickly resolved tophi in patients considered to be responders (uric acid levels <6.0mg/dL for 80% of study) by significantly lowering and maintaining serum uric acid levels.
Jeffrey W. Sherman, MD, FACP, executive vice president, research and development and chief medical officer, Horizon Pharma plc, stated, “This retrospective analysis indicates that Krystexxa provided benefit not only among patients dealing with the challenges typically associated with clinically apparent tophi – such as disability – but also among those who do not have visible tophi.”
Krystexxa, a PEGylated uric acid specific enzyme, is approved for the treatment of refractory chronic gout. It is available as 8mg/mL strength single-use vials.
For more information visit Krystexxa.com.