Table 5 Change in PDAS and EQ-5D-5L scores from baseline to Week 8 (mITT population)

PDAS score

 Baseline, n

60

64

  Mean ± SD

32.3 ± 14.2

28.9 ± 14.2

   Median (Q1, Q3)

32.5 (22.0, 44.0)

27.5 (20.0, 40.0)

   Min, Max

0, 57

0, 60

 Week 8, n

50

53

  Mean ± SD

8.7 ± 9.6

11.6 ± 11.1

   Median (Q1, Q3)

4.5 (2.0, 13.0)

9.0 (2.0, 19.0)

   Min, Max

0, 34

0, 38

  Change from baseline

 − 24.1 ± 14.1

 − 14.4 ± 14.8

   P value^a

 < 0.001

 < 0.001

   P value^b

 < 0.001

-

EQ-5D-5L score, index value

 Baseline, n

60

65

  Mean ± SD

0.5179 ± 0.2095

0.6153 ± 0.2188

   Median (Q1, Q3)

0.5164 (0.3898, 0.6528)

0.6392 (0.5187, 0.7791)

   Min, Max

 − 0.025, 1.000

 − 0.025, 1.000

 Week 8, n

50

53

  Mean ± SD

0.8497 ± 0.1335

0.8385 ± 0.1386

   Median (Q1, Q3)

0.8819 (0.7803, 1.0000)

0.8441 (0.7723, 0.8945)

   Min, Max

0.438, 1.000

0.455, 1.000

  Change from baseline

0.3363 ± 0.2127

0.1798 ± 0.1922

   P value^a

 < 0.001

 < 0.001

   P value^b

 < 0.001

-