Table 4 Known-groups validity of WI-NRS vs. other measures at baseline
Comparator measure | N | Mean WI-NRS score (SD) | T-value | F-value | P-value |
|---|---|---|---|---|---|
Phase 2 cohort | |||||
Self-categorization of pruritus disease severity | 174 | − 2.16 | – | 0.0324 | |
Profile B (moderate) | 123 | 5.8 (1.74) | |||
Profile C (severe) | 51 | 6.5 (2.08) | |||
PGI-S | 171 | – | 6.30 | < 0.0001 | |
None | 1 | 4.00 (−) | |||
Mild | 8 | 4.66 (1.34) | |||
Moderate | 74 | 5.87 (1.64) | |||
Severe | 74 | 5.96 (1.88) | |||
Very severe | 14 | 8.04 (1.90) | |||
Skindex-10 total score | 174 | – | 8.18 | < 0.0001 | |
≤ 25th percentile (best) | 45 | 5.46 (1.81) | |||
> 25th to ≤ 50th percentile | 44 | 5.34 (1.71) | |||
> 50th to ≤ 75th percentile | 46 | 6.40 (1.59) | |||
> 75th percentile (worst) | 39 | 6.97 (1.93) | |||
5-D Itch total score | 174 | – | 5.96 | 0.0007 | |
≤ 25th percentile (least itch) | 44 | 5.16 (1.79) | |||
> 25th to ≤ 50th percentile | 51 | 5.87 (1.54) | |||
> 50th to ≤ 75th percentile | 41 | 6.49 (1.90) | |||
> 75th percentile (worst itch) | 38 | 6.68 (1.96) | |||
MOS Sleep Problem Index II at week 1 | 174 | – | 2.08 | 0.1049 | |
≤ 25th percentile (worst sleep) | 46 | 5.71 (2.04) | |||
> 25th to ≤ 50th percentile | 42 | 5.66 (1.74) | |||
> 50th to ≤ 75th percentile | 44 | 6.51 (1.45) | |||
> 75th percentile (best sleep) | 42 | 6.18 (2.09) | |||
Phase 3 cohort | |||||
5-D Itch total score | 848 | – | – | 128.80 | < 0.0001 |
≤ 25th percentile (best) | 220 | 6.25 (1.12) | |||
> 25th to ≤ 50th percentile | 273 | 6.80 (1.23) | |||
> 50th to ≤ 75th percentile | 154 | 7.55 (1.20) | |||
> 75th percentile (worst) | 201 | 8.40 (1.21) | |||
Skindex-10 total score | 848 | – | – | 63.51 | < 0.0001 |
≤ 25th percentile (least itch) | 218 | 6.30 (1.20) | |||
> 25th to ≤ 50th percentile | 225 | 7.10 (1.41) | |||
> 50th to ≤ 75th percentile | 206 | 7.37 (1.23) | |||
> 75th percentile (worst itch) | 199 | 8.02 (1.34) | |||