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KAPRUVIA® SIGNIFICANTLY REDUCED ITCH
INTENSITY COMPARED TO PLACEBO1

At Week 12, the probability of achieving (vs not) a ≥3-point reduction in Worst Itch Numeric Rating Scale* (WI-NRS) score were almost twice as large with KAPRUVIA® compared with placebo.1

In a pooled analysis of two Phase 3 trials (KALM-1 and KALM-2), after Week 1 significantly more patients achieved a ≥3-point improvement in WI-NRS and sustained at all time points up to Week 12, with 51.1% of patients on KAPRUVIA® compared with 35.2% of patients on placebo.1

ODDS OF ACHIEVING ≥3-POINT IMPROVEMENT IN WI-NRS* SCORE AT WEEK 121

Test Adapted from Topf J et al. 20221

KALM-1 (N=378) and KALM-2 (N=473) were randomised, double-blind, multi-centre, placebo-controlled, Phase 3 trials. There were 851 randomised patients in the pooled analysis (KAPRUVIA® n=426; placebo n=425).

Pooled analysis outcomes
  • Achievement of ≥3-point improvement in WI-NRS score* 
  • Subgroup analyses for WI-NRS response at Week 12
  • Achievement of WI-NRS complete response (≥80% of weekly WI-NRS scores equal to 0 or 1 for the preceding week)
  • Achievement of ≥15-point improvement in Skindex-10 total score
  • Achievement of ≥5-point improvement in 5-D Itch total score
*Missing values were imputed using multiple imputation under missing at random assumption.
In the analysis of complete response, missing values were treated as non-responders.
Skindex-10 and 5-D Itch responses were analysed without imputation for missing values.

These results provide insights into the potential real-world effectiveness of KAPRUVIA® in reducing the itch intensity in HD patients suffering from CKD-associated Pruritus.3

3 out of 4 patients treated with KAPRUVIA® experienced a clinically meaningful reduction in itch intensity measured using the WI-NRS scale* and nearly 30% achieved complete resolution of itch intensity.3

PROPORTION OF PATIENTS ACHIEVING A Change in WI-NRS* at 12 weeks3

Test Adapted from Weiner et al. 20213

Study 3105 was an open-label, multi-centre study of 222 HD patients aged 18–85 receiving 0.5 μg/kg IV KAPRUVIA® three times weekly for 12 weeks.

Outcomes

Percentage of patients achieving ≥3-point and ≥4-point improvements from baseline and complete resolution in WI-NRS score, change from baseline in itch-related quality-of-life at Week 12, and Sleep Quality Score improvement.

KAPRUVIA® SIGNIFICANTLY IMPROVED ITCH-RELATED QUALITY-OF-LIFE COMPARED TO PLACEBO1

KAPRUVIA® is associated with improvements in itch-related quality-of-life from 
Week 4 that continued through to Week 12, as it significantly increased the 
proportion of patients achieving a ≥5-point improvement in 5-D itch total score.1

CLINICALLY SIGNIFICANT CHANGE IN 5-D ITCH SCORE TO WEEK 121

tab-graphtab-graph

KAPRUVIA® (n=426)

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Placebo (n=425)

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Adapted from Topf J et al. 20221

KAPRUVIA® SIGNIFICANTLY IMPROVED ITCH-RELATED QUALITY-OF-LIFE COMPARED TO PLACEBO2

KAPRUVIA® is associated with improvements in itch-related quality-of-life from Week 4 that continued through to Week 12, as it significantly increased the proportion of patients achieving a ≥5-point improvement in Skindex-10§ total score.2

 

CLINICALLY SIGNIFICANT CHANGE IN SKINDEX-10§ SCORE TO WEEK 122

tab-SKINDEX-10tab-SKINDEX-10

KAPRUVIA® (n=426)

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Placebo (n=425)

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Adapted from Topf et al. 20212

KALM-1 (N=378) and KALM-2 (N=473) were randomised, double-blind, multi-centre, placebo-controlled, Phase 3 trials. There were 851 randomised patients in the pooled analysis (KAPRUVIA® n=426; placebo n=425).

Pooled analysis outcomes
  • Achievement of ≥3-point improvement in WI-NRS score* 
  • Subgroup analyses for WI-NRS response at Week 12
  • Achievement of WI-NRS complete response (≥80% of weekly WI-NRS scores equal to 0 or 1 for the preceding week)
  • Achievement of ≥15-point improvement in Skindex-10 total score
  • Achievement of ≥5-point improvement in 5-D Itch total score
*Missing values were imputed using multiple imputation under missing at random assumption.
In the analysis of complete response, missing values were treated as non-responders.
Skindex-10 and 5-D Itch responses were analysed without imputation for missing values.

KAPRUVIA® MAINTAINED IMPROVEMENTS IN ITCH-RELATED QUALITY-OF-LIFE OVER 64 WEEKS IN A DOUBLE-BLIND AND OPEN-LABEL STUDY3

Improvements in 5-D itch response continued over a 52-week open-label extension (OLE) of pooled KALM-1 and KALM-2.3

Marked improvement in 5-D itch scores emerged in patients who switched from placebo to KAPRUVIA® within a few weeks.3

MEAN IMPROVEMENT IN 5-D ITCH TOTAL SCORE DURING DOUBLE-BLIND AND OLE PHASES3

Test

Phase A: KAPRUVIA® vs Placebo – The first 12 weeks of the study was double-blinded with patients receiving either KAPRUVIA® or placebo.

Phase B: There was an open-label extension to the study for up to 1 year where patients from Phase 1 either continued KAPRUVIA® or were switched to KAPRUVIA® from placebo.

Adapted from Fishbane et al. 20213

KAPRUVIA® continued

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Placebo switched to KAPRUVIA®

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Long-term quality-of-life and pooled safety data from the placebo-controlled and open-label extension (OLE) periods of the Phase 3 KALM-1 and KALM-2 trials.

HD patients with moderate-to-severe CKD-associated Pruritus were randomised to IV KAPRUVIA® 0.5 μg/kg or placebo three times per week for 12 weeks, followed by a ≤52-week OLE phase in which all patients received IV KAPRUVIA® 0.5 μg/kg three times per week. Itch-related quality-of-life was assessed with the 5-D itch scale. Safety was evaluated based on safety assessments and AEs.

These results provide insights into the potential real-world effectiveness of KAPRUVIA® in improving the sleep quality in HD patients suffering from CKD-associated Pruritus.3

2 out of 3 patients treated with KAPRUVIA® experienced a ≥3-point improvement in Sleep Quality score# and nearly 1 in 5 achieved complete resolution of sleep problems.3

PROPORTION OF PATIENTS ACHIEVING A Change in Sleep Quality# score at 12 weeks3

Test Adapted from Weiner et al. 20213