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
ODDS OF ACHIEVING ≥3-POINT IMPROVEMENT IN WI-NRS* SCORE AT WEEK 121
POOLED KALM-1 AND KALM-2 METHODOLOGY1,2
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® EFFECTIVELY REDUCED ITCH INTENSITY IN AN OPEN-LABEL STUDY3
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
STUDY 3105 METHODOLOGY3
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 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 5-D itch‡ total score.2
CLINICALLY SIGNIFICANT CHANGE IN 5-D ITCH‡ SCORE TO WEEK 122
KAPRUVIA® (n=426)
Placebo (n=425)
Adapted from Topf et al. 20212
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
KAPRUVIA® (n=426)
Placebo (n=425)
Adapted from Topf et al. 20212
POOLED KALM-1 AND KALM-2 METHODOLOGY1,2
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 STUDY4
Improvements in 5-D itch response continued over a 52-week open-label extension (OLE) of pooled KALM-1 and KALM-2.4
Marked improvement in 5-D itch‡ scores emerged in patients who switched from placebo to KAPRUVIA® within a few weeks.4
MEAN IMPROVEMENT IN 5-D ITCH‡ TOTAL SCORE DURING DOUBLE-BLIND AND OLE PHASES4
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. 20214
KAPRUVIA® continued
Placebo switched to KAPRUVIA®
POOLED KALM-1 AND KALM-2 OLE METHODOLOGY4
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.
KAPRUVIA® SIGNIFICANTLY IMPROVED SLEEP QUALITY IN AN OPEN-LABEL STUDY3
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
PROPORTION OF PATIENTS ACHIEVING A Change in Sleep Quality# score at 12 weeks3
STUDY 3105 METHODOLOGY3
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.
