Phase III MIRROR trial of Krystexxa meets primary endpoint in chronic gout.
Results were from the Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Krystexxa trial [MIRROR randomized controlled trial (RCT)].
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). no new safety concerns were identified. these results are aligned with published literature and the prior original pivotal clinical trials of krystexxa monotherapy which showed 42% (36 of 85) of dosed patients had a complete sua response and met the primary endpoint of maintaining sua><6 mg dl at least 80% of the time in months 3 and 6. data from the trial are expected to be presented at an upcoming medical congress. horizon plans to submit a supplemental biologics license application (sbla) to the fda in the first quarter of 2022.></6></0.001).>
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