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The results from the completed PROTECT trial (NCT04087720) demonstrated that Krystexxa (Pegloticase & Methotrexate) provide a substantial and sustained decrease in serum uric acid (sUA) for patients with uncontrolled gout who had received a kidney transplant.
The findings indicated that the use of KRYSTEXXA with an immunomodulator may improve persistence to therapy. Approx 90% of the evaluated population met the sUA treatment target and those who received immunomodulation after starting on KRYSTEXXA were less likely to discontinue.
Results show that 71% (71 of 100) of patients who were randomized to receive KRYSTEXXA with methotrexate compared to 40% (21 of 52) of patients who were randomized to receive KRYSTEXXA with placebo achieved the primary endpoint (p<0.001).
The Reducing Immunogenicity of Pegloticase trial showed that 86% of patients receiving co-therapy of KRYSTEXXA with the immunomodulator mycophenolate mofetil achieved serum uric acid (sUA) ≤ 6 mg/dL at 12 weeks vs 40% of patients (4 of 10) receiving KRYSTEXXA monotherapy.
The current recommended dosing of KRYSTEXXA for adult patients is 8 mg given as intravenous infusions every two weeks, with each dose infused over at least two hours.
The Company announced two new KRYSTEXXA development programs: KRYSTEXXA, with methotrexate monthly dosing trial and a KRYSTEXXA retreatment trial evaluating KRYSTEXXA, with methotrexate, in patients who have previously failed KRYSTEXXA.
The real-world usage analysis illustrates that KRYSTEXXA is effectively employed and well-tolerated among dialysis patients. KRYSTEXXA® is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
In the open-label trial, 79 percent of patients who received both KRYSTEXXA and methotrexate (11 of 14 enrolled patients) maintained therapeutic response during Month 6 (defined as sUA <6 mg/dL).
Data presentations demonstrate that KRYSTEXXA® (pegloticase injection) can be co-prescribed with three commonly used immunomodulators in rheumatology to potentially help more people with chronic gout refractory to conventional therapies.
Presentations of trial data and in-practice cases will provide results on KRYSTEXXA® (pegloticase injection) with commonly used immunomodulators to help more people with chronic gout refractory to conventional therapies potentially achieve complete response to treatment.