POEM groups at week 4 | ||||
---|---|---|---|---|
Much Improved (> 1 Category Improvement) | Improved (1 Category Improvement) | Stable (No Category Change) | Declined (≥ 1 Category Worsening) | |
Itch NRS | ||||
BREEZE-AD1 | ||||
Sample size | 63 | 191 | 301 | 26 |
Mean (SD) change | − 3.85 (1.943) | − 2.29 (1.779) | − 1.07 (1.629) | 0.21 (1.942) |
Median change | − 3.67 | − 2.14 | − 0.86 | 0.64 |
Between-group comparisonsa | – | < 0.0001 | < 0.0001 | 0.0002 |
BREEZE-AD2 | ||||
Sample size | 69 | 190 | 286 | 23 |
Mean (SD) at baseline | − 3.90 (2.318) | − 2.45 (2.101) | − 1.08 (1.634) | 0.14 (1.049) |
Median change | − 3.71 | − 2.29 | − 0.86 | 0.17 |
Between-group comparisonsa | – | < 0.0001 | < 0.0001 | 0.0030 |
BREEZE-AD5 | ||||
Sample size | 35 | 114 | 217 | 13 |
Mean (SD) at baseline | − 4.12 (2.261) | − 2.56 (2.059) | − 1.15 (1.627) | − 0.81 (1.569) |
Median change | − 3.71 | − 2.30 | − 0.86 | − 0.57 |
Between-group comparisonsa | – | 0.0002 | < 0.0001 | 0.9320 |
Skin pain NRS | ||||
BREEZE-AD1 | ||||
Sample size | 63 | 191 | 301 | 26 |
Mean (SD) change | − 3.49 (2.111) | − 2.24 (1.970) | − 0.97 (1.773) | 0.31 (1.726) |
Median change | − 3.14 | − 1.86 | − 0.71 | 0.48 |
Between-group comparisonsa | – | < 0.0001 | < 0.0001 | 0.0007 |
BREEZE-AD2 | ||||
Sample size | 69 | 190 | 286 | 23 |
Mean (SD) at baseline | − 4.13 (2.412) | − 2.66 (2.290) | − 0.97 (1.826) | 0.20 (1.206) |
Median change | − 4.00 | − 2.29 | − 0.86 | 0.43 |
Between-group comparisonsa | – | < 0.0001 | < 0.0001 | 0.0118 |
BREEZE-AD5 | ||||
Sample size | 35 | 114 | 217 | 13 |
Mean (SD) at baseline | − 4.24 (2.361) | − 2.49 (2.119) | − 1.19 (1.889) | − 0.38 (1.667) |
Median change | − 4.00 | − 2.15 | − 0.90 | − 0.57 |
Between-group comparisonsa | – | < 0.0001 | < 0.0001 | 0.3379 |
ADSS item 1 | ||||
BREEZE-AD1 | ||||
Sample size | 63 | 191 | 301 | 26 |
Mean (SD) change | − 1.31 (0.958) | − 0.75 (0.828) | − 0.42 (0.813) | 0.31 (1.061) |
Median change | − 1.29 | − 0.71 | − 0.29 | 0.00 |
Between-group comparisonsa | – | < 0.0001 | < 0.0001 | < 0.0001 |
BREEZE-AD2 | ||||
Sample size | 69 | 190 | 286 | 23 |
Mean (SD) at baseline | − 1.30 (0.886) | − 0.85 (0.894) | − 0.35 (0.823) | 0.20 (0.507) |
Median change | − 1.14 | − 0.71 | − 0.31 | 0.14 |
Between-group comparisonsa | – | 0.0001 | < 0.0001 | 0.0062 |
BREEZE-AD5 | ||||
Sample size | 35 | 114 | 217 | 13 |
Mean (SD) at baseline | − 1.49 (0.918) | − 0.88 (0.839) | − 0.46 (0.814) | − 0.12 (0.787) |
Median change | − 1.43 | − 0.88 | − 0.29 | 0.00 |
Between-group comparisonsa | – | 0.0014 | < 0.0001 | 0.2903 |
ADSS item 2 | ||||
BREEZE-AD1 | ||||
Sample size | 63 | 191 | 301 | 26 |
Mean (SD) change | − 1.85 (2.836) | − 1.45 (3.027) | − 0.70 (2.119) | 0.35 (2.133) |
Median change | − 1.00 | − 0.71 | − 0.43 | 0.15 |
Between-group comparisonsa | – | 0.2945 | 0.0019 | 0.0375 |
BREEZE-AD2 | ||||
Sample size | 69 | 190 | 286 | 23 |
Mean (SD) at baseline | − 1.34 (1.490) | − 1.12 (2.629) | − 0.52 (2.105) | 0.12 (0.601) |
Median change | − 0.86 | − 0.56 | − 0.43 | 0.00 |
Between-group comparisonsa | – | 0.3931 | 0.0096 | 0.1092 |
BREEZE-AD5 | ||||
Sample size | 35 | 114 | 217 | 13 |
Mean (SD) at baseline | − 1.66 (1.522) | − 1.13 (1.365) | − 0.54 (1.208) | 0.06 (0.791) |
Median change | − 1.29 | − 0.67 | − 0.31 | 0.29 |
Between-group comparisonsa | – | 0.1450 | 0.0001 | 0.1491 |
ADSS item 3 | ||||
BREEZE-AD1 | ||||
Sample size | 20 | 80 | 201 | 9 |
Mean (SD) change | − 1.15 (1.024) | − 0.73 (0.833) | − 0.31 (0.807) | 0.27 (0.843) |
Median change | − 1.21 | − 0.66 | − 0.20 | 0.29 |
Between-group comparisonsa | – | 0.0468 | 0.0002 | 0.0500 |
BREEZE-AD2 | ||||
Sample size | 19 | 72 | 165 | 13 |
Mean (SD) at baseline | − 1.27 (0.700) | − 0.70 (0.814) | − 0.24 (0.849) | 0.05 (0.472) |
Median change | − 1.26 | − 0.60 | − 0.29 | 0.00 |
Between-group comparisonsa | – | 0.0069 | < 0.0001 | 0.2670 |
BREEZE-AD5 | ||||
Sample size | 14 | 48 | 138 | 7 |
Mean (SD) at baseline | − 1.54 (0.856) | − 1.05 (0.739) | − 0.41 (0.749) | − 0.47 (1.075) |
Median change | − 1.38 | − 1.00 | − 0.36 | − 0.29 |
Between-group comparisonsa | – | 0.1086 | < 0.0001 | 0.6526 |