Phase III MIRROR trial of Krystexxa shows response in uncontrolled gout.-Horizon Therapeutics

The MIRROR randomized controlled trial outcomes provided a clear view of improvements in patient response and reductions in infusion reactions for Krystexxa plus low-dose (15 mg/week) methotrexate compared to Krystexxa plus placebo.

Results from evaluation during Month 6 included: Patient response rate increased by greater than 32% (p<0.0001): response rate in the group randomized to receive krystexxa plus methotrexate was 71.0% (71 of 100) of patients as compared to 38.5% (20 of 52) of patients randomized to receive krystexxa plus placebo. as the primary endpoint, response rate was defined as serum uric acid (sua) less than 6 mg dl for more than 80% of the time during weeks 20-24. infusion reactions were significantly reduced: 4.2% (4 of 96) of patients who were randomized to receive krystexxa plus methotrexate experienced an infusion reaction vs. 30.6% (15 of 49) of patients who were randomized to receive krystexxa plus placebo. complete resolution of at least one tophus improved by 20.8% (p="0.043):" 34.6% (18 of 52) of patients who were randomized to receive krystexxa plus methotrexate had complete resolution of at least one tophus at week 24 vs. 13.8% (4 of 29) of patients who were randomized to receive krystexxa plus placebo. no new safety concerns were identified.></0.0001):>

Additional presentations by Horizon during The EULAR 2022 European Congress of Rheumatology, June 1 – 4 in Copenhagen, include the exploratory findings from the PROTECT trial of Krystexxa with immunomodulation in kidney transplant patients and the impact of chronic gout refractory to conventional therapies (uncontrolled gout).