TABLE 1.
Change from baseline to Week 48 in key outcomes (combined studies and multiple imputation)
| Characteristics | Baseline a | Adjusted b change from baseline to Week 48 (multiple imputation) c (n = 57) d | p value |
|---|---|---|---|
| ItchRO(Obs) | 2.7 [2.4, 3.3] | −1.59 (0.11) [−1.81, −1.36] | <0.0001 |
| CSS | 3.0 [2.0, 4.0] | −1.36 (0.16) [−1.67, −1.05] | <0.0001 |
| Serum bile acid (umol/L) | 181.1 [83.4, 329.0] | −79.88 (17.60) [−114.57, −45.19] | <0.0001 |
| PedsQL total, parent | 63.5 [47.8, 78.2] | 10.17 (2.88) [4.48, 15.86] | 0.0006 |
| Multidimensional fatigue scale | 58.6 [45.8, 72.2] | 13.97 (3.09) [7.85, 20.08] | <0.0001 |
| TB (mg/dl) | 2.1 [0.9, 7.4] | 0.26 (0.58) [−0.89, 1.41] | 0.6567 |
| Total cholesterol (mg/dl) | 309.5 [234.0, 443.0] | −74.78 (30.58) [−135.66, −13.91] | 0.0167 |
| ALT (U/L) | 130.0 [91.0–189.0] | 38.13 (10.69) [17.08, 59.18] | 0.0004 |
| Albumin (g/dl) | 4.5 [4.3–4.7] | 0.04 (0.05) [−0.06, 0.14] | 0.423 |
| Platelet (103/ul) | 267.0 [217.0–382.0] | −38.53 (14.88) [−68.82, −8.23] | 0.0143 |
| Height z‐score | −1.6 [−2.5, −1.0] | 0.34 (0.16) [0.01, 0.67] | 0.0463 |
| Weight z‐score | −1.3 [−2.0, −0.6] | 0.20 (0.13) [−0.06, 0.46] | 0.1245 |
Median [Q1, Q3].
Least squares mean, SEM, 95% CI, and p value based on separate linear mixed models (random intercept and slope for each subject) for each characteristic, with dependent variable as the change from baseline controlling for study (ITCH/IMAGINE II or IMAGO/IMAGINE), week (0, 2, 4, 8, 12, 24, 36, and 48), age at baseline, and baseline level of the dependent variable as covariates.
Ten imputed data sets were generated using the multivariate normal distribution (MVN) method for continuous measures and the fully conditional specification (FCS) method for categorical methods. The multiple imputation model included all characteristics at weeks −13, 0, 2, 4, 8, 12, 24, 36, and 48, study (ITCH/IMAGINE II or IMAGO/IMAGINE), age at baseline (years), and sex.
Mean (SEM) [95% CI].