TABLE 2.
Comparison of baseline parameters of ITCH participants and LOGIC ALGS natural history cohort
| ITCH (All participants) | LOGIC ALGS natural history cohort (unweighted) | LOGIC ALGS natural history cohort (weighted) | |||
| N | 37 | 59 | 59 | ||
| Summary statistics, mean (SD) [n], median | Summary statistics | SMD% (p value) | Summary statistics | SMD% (p value a ) | |
| Age, years | 6.8 (4.5) [37], 6.0 | 4.1 (3.2) [59], 2.5 | 69% (<0.001) | 6.2 (3.1) [59], 6.5 | 16% (0.32) |
| Age | (<0.001) | (1.00) | |||
| <2 years | 2 (5%) | 26 (44%) | 3.2 (5%) | ||
| 2–4 years | 12 (32%) | 13 (22%) | 19.1 (32%) | ||
| 5–7 years | 11 (30%) | 10 (17%) | 17.5 (30%) | ||
| 8–18 years | 12 (33%) | 10 (17%) | 19.1 (32%) | ||
| Gender | (1.00) | (0.63) | |||
| Female | 16 (43%) | 25 (42%) | 22.2 (38%) | ||
| Male | 21 (57%) | 33 (56%) | 36.7 (62%) | ||
| Not reported | 1 (2%) | 0.1 (0.2%) b | |||
| Race | (0.053) | (0.16) | |||
| White | 29 (78%) | 30 (51%) | 33.7 (57%) | ||
| Black | 5 (14%) | 13 (22%) | 9.3 (16%) | ||
| Non‐White, Non‐Black | 2 (5%) | 9 (15%) | 11.1 (19%) | ||
| Not reported | 1 (3%) | 7 (12%) | 4.9 (8%) | ||
| Ethnicity | (0.63) | (0.91) | |||
| Hispanic | 7 (18.9%) | 9 (15%) | 11.7 (20%) | ||
| Non‐Hispanic | 30 (81%) | 48 (81%) | 47.0 (80%) | ||
| Not reported | 2 (3%) | 0.2 (0.4%) b | |||
| ItchRO | 2.9 (0.60) [37], 2.9 | ||||
| CSS, range 0–4 | 3.0 (1.1) [37], 3.0 | 2,9 (0.7) [59], 3.0 | 11% (0.47) | 2.8 (0.7) [59], 2.4 | 22% (0.16) |
| PesQL parent total score, range 0–100 | 65 (20.1) [35], 67 | 78.8 (12.86) [21], 84.7 | −82% (<0.001) | 79.0 (9.7) [21], 83.1 | −89% (<0.001) |
| Total bilirubin (mg/dl) [3] | 5.3 (6.18) [37], 2.1 | 4.9 (5.42) [57], 2.3 | 7% (0.67) | 3.7 (5.2) [57], 1.4 | 28% (0.07 |
| Cholesterol (mg/dl) | 405.7 (313.6) [37], 320 | 522.4 (342.6) [24], 454 | −36% (0.06) | 408.1 (151.8) [24], 301.4 | −1% (0.94) |
| Serum bile acid (umol/L) | 216.3 (203.3) [37], 155.5 | 174.2 (9.0) [14], 179.2 | 27% (0.14) | 147.5 (29.9) [14], 160.0 | 47% (0.007) |
| ALT (IU/L) | 158.7 (86.5) [37], 137 | 196.7 (99.5) [57], 187 | −41% (0.007) | 184.7 (109.2) [57], 163.9 | −26% (0.07) |
| GGT (IU/L) | 494.9 (379.8) [37], 329 | 542.1 (460.4) [54], 388 | −11% (0.45) | 495.6 (439.6) [54], 292 | 0% (0.99) |
| Albumin (g/dl) | 4.5 (0.4) [37], 4.6 | 4.1 (0.4) [57], 4.1 | 95% (<0.001) | 4.2 (0.4) [57], 4.1 | 76% (<0.001) |
| Platelets (103/mm3) | 287.0 (109.5) [37], 258 | 308.0 (110.4) [51], 308 | −19% (0.214) | 289.7 (105.9) [51], 263.7 | −3% (0.87) |
| Height z score | −1.6 (1.2) [37], −1.6 | −2.3 (1.3) [58], −2.3 | 59% (<0.001) | −1.9 (1.0) [58], −2.0 | 26% (0.09) |
| Weight z score | −1.3 (1.1) [37], −1.3 | −1.7 (0.9) [58], −1.7 | 39% (0.01) | −1.5 (0.9) [58], −1.4 | 17% (0.26) |
Abbreviation: SMD, standardized mean difference.
a
Compare weighted LOGIC ALGS natural history cohort to the ITCH/IMAGINE II participants. Continuous variables use t‐tests, categorical variables use Wald Chi‐square tests.
b
Excluded from weighted Wald Chi‐square test due to empty cell issue.