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Efficacy data

PrKORSUVA® reduced itch intensity (≥3-point improvement in WI-NRS) at Week 12 from baseline vs. placebo1†s

chart

Number observed with ≥3-point NRS improvement: 157 (Yes=82, No=75; missing n=32) and 165 (Yes=51, No=114; missing n=24) for KORSUVA and placebo, respectively. Counts were based on non-missing data.
Estimated percent and P-value used a logistic regression model with terms for treatment group, baseline Worst Itching Intensity numerical rating scale score, use of anti-itch medication during the week prior to randomization, and the presence of specific medical conditions. Missing values were imputed using multiple imputation under missing-at-random missing data assumption for interim patients and post-interim patients separately.
Adapted from the Product Monograph.1

KALM-2 study: 54.0% for KORSUVA vs. 42.2% for placebo (P=0.02; n=237 and 236, respectively. Number observed with ≥3-point NRS improvement: 191 [Yes=95, No=96; missing n=46] and 207 [Yes=77, No=130; missing n=29] for KORSUVA and placebo, respectively. Counts were based on non-missing data.)

Demonstrated results for itch-related QoL (Skindex-10 and 5-D Itch scores) at Week 12 (secondary endpoints)1

In KALM 2, Skindex-10 and 5-D Itch scores did not reach statistical significance.

KALM-2 study: -16.6 for KORSUVA vs. -14.8 for placebo (P=0.171; n=237 and 236, respectively)
KALM-2 study: -4.9 for KORSUVA vs. -3.8 for placebo (n=237 and 236, respectively; not tested based on the hierarchical testing order, as the prior secondary endpoint [total Skindex-10 Scale score at Week 12] was not statistically significant.)

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Mechanism of Action

Safety and Tolerability Profile

Dosing and Administration

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