Table 5 Within group mean and median change scores for responsiveness of the itch NRS, skin pain NRS, and ADSS to change on the POEM between baseline and week 16 for BREEZE-AD1, BREEZE-AD2, and BREEZE-AD5

Itch NRS

BREEZE-AD1

Sample Size

71

198

263

25

Mean (SD) change

− 4.64 (2.333)

− 3.03 (2.025)

− 1.42 (1.986)

0.10 (1.964)

Median change

− 4.86

− 3.14

− 1.14

− 0.12

Between-group comparisons^a

–

< 0.0001

< 0.0001

0.0007

BREEZE-AD2

Sample size

85

163

263

23

Mean (SD) at baseline

− 4.49 (2.162)

− 3.01 (2.183)

− 1.47 (2.166)

0.13 (2.602)

Median change

− 4.5

− 2.86

− 1.29

0.07

Between-group comparisons^a

–

< 0.0001

< 0.0001

0.0042

BREEZE-AD5

Sample size

49

104

176

8

Mean (SD) at baseline

− 5.39 (2.523)

− 3.59 (2.245)

− 1.46 (2.109)

− 0.01 (3.105)

Median change

− 5.43

− 3.54

− 1.31

− 0.21

Between-group comparisons^a

–

< 0.0001

< 0.0001

0.1167

Skin pain NRS

BREEZE-AD1

Sample size

71

198

263

25

Mean (SD) change

− 4.49 (2.580)

− 2.82 (2.289)

− 1.34 (2.220)

0.53 (2.236)

Median change

− 4.52

− 2.79

− 1.00

0.00

Between-group comparisons^a

–

< 0.0001

< 0.0001

0.0002

BREEZE-AD2

Sample size

85

163

263

23

Mean (SD) at baseline

− 4.60 (2.396)

− 3.17 (2.309)

− 1.36 (2.395)

0.04 (2.594)

Median change

− 4.29

− 2.74

− 1.29

0.25

Between-group comparisons^a

–

< 0.0001

< 0.0001

0.0203

BREEZE-AD5

Sample size

49

104

176

8

Mean (SD) at baseline

− 4.80 (2.842)

− 3.60 (2.398)

− 1.48 (2.354)

0.21 (4.211)

Median change

− 4.86

− 3.57

− 1.21

− 0.38

Between-group comparisons^a

–

0.0216

< 0.0001

0.0932

ADSS item 1

BREEZE-AD1

Sample size

71

198

263

25

Mean (SD) change

− 1.40 (1.045)

− 0.98 (0.904)

− 0.51 (0.977)

0.34 (1.011)

Median change

− 1.17

− 0.91

− 0.29

0.00

Between-group comparisons^a

–

0.0022

< 0.0001

< 0.0001

BREEZE-AD2

Sample size

85

163

263

23

Mean (SD) at baseline

− 1.45 (0.924)

− 1.12 (0.951)

− 0.38 (0.937)

0.10 (0.739)

Median change

− 1.43

− 1.00

− 0.29

0.00

Between-group comparisons^a

–

0.0144

< 0.0001

0.0453

BREEZE-AD5

Sample size

49

104

176

8

Mean (SD) at baseline

− 1.69 (1.245)

− 1.30 (0.956)

− 0.34 (0.842)

− 0.06 (0.973)

Median change

− 1.71

− 1.07

− 0.14

0.00

Between-group comparisons^a

–

0.0386

< 0.0001

0.5370

ADSS item 2

BREEZE-AD1

Sample size

71

198

263

25

Mean (SD) change

− 2.47 (4.141)

− 1.60 (2.491)

− 1.05 (2.954)

− 0.04 (1.483)

Median change

− 1.14

− 1.00

− 0.57

0.00

Between-group comparisons^a

–

0.0431

0.0695

0.0957

BREEZE-AD2

Sample size

85

163

263

23

Mean (SD) at baseline

− 1.63 (1.604)

− 1.36 (2.434)

− 0.70 (1.655)

− 0.43 (1.183)

Median change

− 1.14

− 0.86

− 0.45

− 0.29

Between-group comparisons^a

–

0.2260

0.0004

0.6256

BREEZE-AD5

Sample size

49

104

176

8

Mean (SD) at baseline

− 2.16 (1.665)

− 1.55 (2.631)

− 0.51 (1.526)

0.24 (0.592)

Median change

− 1.86

− 0.86

− 0.43

0.00

Between-group comparisons^a

–

0.0753

0.0001

0.2183

ADSS item 3

BREEZE-AD1

Sample size

22

71

162

10

Mean (SD) change

− 1.00 (0.916)

− 0.77 (0.981)

− 0.32 (0.868)

0.70 (1.023)

Median change

− 0.98

− 0.71

− 0.23

0.65

Between-group comparisons^a

–

0.2873

0.0011

0.0005

BREEZE-AD2

Sample size

9

51

141

10

Mean (SD) at baseline

− 1.11 (0.906)

− 0.76 (0.869)

− 0.22 (0.940)

0.43 (0.838)

Median change

− 1.25

− 0.80

− 0.17

0.50

Between-group comparisons^a

–

0.3592

0.0003

0.0574

BREEZE-AD5

Sample size

15

52

115

2

Mean (SD) at baseline

− 1.60 (0.951)

− 1.27 (1.021)

− 0.18 (0.794)

− 0.79 (1.111)

Median change

− 1.86

− 1.14

0.00

− 0.79

Between-group comparisons^a

–

0.4839

< 0.0001

0.2654