The approval was based on the (MIRROR) trial evaluating Krystexxa + methotrexate vs Krystexxa & PBO in a ratio (2:1) in 152 adults with uncontrolled gout for 52wks.
The results showed a 30% point increase in patient response rate during 6 & 12mos., 71% vs 39% of patients achieved the 1EPs @6mos., 60% vs 31% achieved a complete response @12mos., 4% vs 31% experienced infusion reactions with no new safety signals, 22%-point increase in the complete resolution of one tophus @12mos. 54% vs 31% had complete resolution of one tophus, no new tophus and no single tophus showed progression @52wk.
Additionally, the patients treated with Krystexxa achieved a 32% point improvement in treatment response rate with 71% vs 39% achieved a sustained urate-lowering response @6mos.
Ref: Horizon | Image: Horizon
