Table 4 Known-groups validity of the itch NRS, skin pain NRS, and ADSS using PGI-S-AD and POEM subgroups at baseline for BREEZE-AD1, BREEZE-AD2, and BREEZE-AD5

Itch NRS

BREEZE-AD1

Sample size

118

497

13

125

470

LSM (SE) at baseline

4.22 (0.296)

7.43 (0.254)

N/A^b

5.35 (0.322)

7.46 (0.283)

Between-group comparisons^a

–

< 0.0001

–

N/A^b

< 0.0001

BREEZE-AD2

Sample size

110

490

26

126

445

LSM (SE) at baseline

3.58 (0.502)

6.79 (0.471)

3.05 (0.628)

5.09 (0.537)

6.89 (0.510)

Between-group comparisons^a

–

< 0.0001

–

< 0.0001

< 0.0001

BREEZE-AD5

Sample size

61

364

9

72

342

LSM (SE) at baseline

3.95 (0.328)

7.59 (0.260)

N/A^b

4.89 (0.362)

7.29 (0.286)

Between-group comparisons^a

–

< 0.0001

–

N/A^b

< 0.0001

Skin pain NRS

BREEZE-AD1

Sample Size

118

497

13

125

470

LSM (SE) at baseline

3.36 (0.372)

6.73 (0.319)

N/A^b

4.58 (0.394)

6.75 (0.346)

Between-group comparisons^a

–

< 0.0001

–

N/A^b

< 0.0001

BREEZE-AD2

Sample size

110

490

26

126

445

LSM (SE) at baseline

2.94 (0.617)

6.29 (0.580)

1.96 (0.723)

4.09 (0.619)

6.47 (0.587)

Between-group comparisons^a

–

< 0.0001

–

< 0.0001

< 0.0001

BREEZE-AD5

Sample size

61

364

9

72

342

LSM (SE) at baseline

3.55 (0.436)

7.07 (0.345)

N/A^b

4.05 (0.446)

6.83 (0.353)

Between-group comparisons^a

–

< 0.0001

–

N/A^b

< 0.0001

ADSS item 1

BREEZE-AD1

Sample size

118

497

13

125

470

LSM (SE) at baseline

1.04 (0.167)

2.36 (0.143)

N/A^b

1.45 (0.174)

2.38 (0.152)

Between-group comparisons^a

–

< 0.0001

–

N/A^b

< 0.0001

BREEZE-AD2

Sample size

110

490

26

126

445

LSM (SE) at baseline

1.06 (0.286)

2.29 (0.269)

0.94 (0.341)

1.53 (0.292)

2.34 (0.277)

Between-group comparisons^a

–

< 0.0001

–

0.0089

< 0.0001

BREEZE-AD5

Sample size

61

364

9

72

342

LSM (SE) at baseline

1.04 (0.201)

2.54 (0.159)

N/A^b

1.38 (0.209)

2.43 (0.165)

Between-group comparisons^a

–

< 0.0001

–

N/A^b

< 0.0001

ADSS item 2

BREEZE-AD1

Sample size

118

497

13

125

470

LSM (SE) at baseline

1.18 (0.809)

3.22 (0.694)

N/A^b

1.36 (0.805)

3.35 (0.706)

Between-group comparisons^a

–

< 0.0001

–

N/A^b

0.0001

BREEZE-AD2

Sample size

110

490

26

126

445

LSM (SE) at baseline

1.00 (0.622)

2.11 (0.585)

0.91 (0.727)

1.46 (0.622)

2.15 (0.590)

Between-group comparisons^a

–

< 0.0001

–

0.2514

0.0024

BREEZE-AD5

Sample Size

61

364

9

72

342

LSM (SE) at baseline

1.12 (0.525)

2.87 (0.416)

N/A^b

1.32 (0.529)

2.79 (0.418)

Between-group comparisons^a

–

< 0.0001

–

N/A^b

0.0001

ADSS item 3

BREEZE-AD1

Sample Size

63

442

10

74

415

LSM (SE) at baseline

1.42 (0.175)

2.46 (0.136)

N/A^b

1.74 (0.172)

2.50 (0.139

Between-group comparisons^a

–

< 0.0001

–

N/A^b

< 0.0001

BREEZE-AD2

Sample size

60

423

11

84

385

LSM (SE) at baseline

1.30 (0.267)

2.35 (0.240)

N/A^b

1.63 (0.266)

2.38 (0.247)

Between-group comparisons^a

–

< 0.0001

–

N/A^b

< 0.0001

BREEZE-AD5

Sample size

38

324

4

48

309

LSM (SE) at baseline

1.53 (0.190)

2.82 (0.137)

N/A^b

2.02 (0.195)

2.72 (0.143)

Between-group comparisons^a

–

< 0.0001

-

N/A^b

< 0.0001