Table 2.
Changes from baseline in efficacy endpoints (PPS)
| Daily rhGH 0.37 mg/kg/week (n = 14) | LB03002 0.5 mg/kg/week (n = 14) | LB03002 0.7 mg/kg/week (n = 14) | |
|---|---|---|---|
| ΔHeight, cm | |||
| Week 13 | 2.77 (2.49, 3.05) | 2.64 (2.37, 2.91) | 2.54 (2.25, 2.82) |
| Week 26 | 5.53 (5.14, 5.92) | 4.81 (4.43, 5.18) | 5.19 (4.8, 5.59) |
| ΔHeight velocity, cm/year | |||
| Week 13 | 4.99 (3.92, 6.07) | 4.62 (3.53, 5.71) | 4.12 (3, 5.24) |
| Week 26 | 5.08 (4.35, 5.81) | 3.65 (2.91, 4.39) | 4.38 (3.63, 5.14) |
| ΔHeight SDS for CA | |||
| Week 26 | 0.65 (0.57, 0.74) | 0.49 (0.4, 0.58) | 0.58 (0.5, 0.67) |
| ΔHeight SDS for BA | |||
| Week 26 | 0.51 (0.32, 0.69) | 0.45 (0.27, 0.64) | 0.32 (0.14, 0.5) |
| ΔBA, years | |||
| Week 26 | 0.62 (0.48, 0.76) | 0.55 (0.42, 0.69) | 0.73 (0.6, 0.87) |
| ΔBA/ΔCA | |||
| Week 26 | 0.02 (0, 0.04) | 0 (−0.02, 0.02) | 0.03 (0.01, 0.05) |
| ΔIGF-I, ng/mL | |||
| Week 13 | 73.6 (40.43, 106.76) | 24.89 (−7.92, 57.7) | 50.79 (19.17, 82.4) |
| Week 26 | 92.3 (40.06, 144.55) | 28.3 (−23.39, 79.99) | 73.8 (23.99, 123.6) |
| ΔIGF-I SDS | |||
| Week 13 | 0.95 (0.43, 1.46) | 0.35 (−0.16, 0.87) | 0.87 (0.35, 1.4) |
| Week 26 | 1.3 (0.52, 2.08) | 0.41 (−0.36, 1.19) | 1.12 (0.33, 1.91) |
| ΔIGFBP-3, ng/mL | |||
| Week 13 | 681.03 (324.66, 1037.41) | 149.87 (−214.75, 514.49) | 379.84 (26.14, 733.53) |
| Week 26 | 806.84 (453.95, 1159.73) | 276.97 (−84.09, 638.03) | 622.96 (272.72, 973.2) |
| ΔIGFBP-3 SDS | |||
| Week 13 | 1.34 (0.55, 2.13) | 0.32 (−0.49, 1.12) | 0.87 (0.08, 1.65) |
| Week 26 | 1.69 (0.93, 2.46) | 0.62 (−0.15, 1.4) | 1.31 (0.55, 2.06) |
Data are changes from baseline at each time point, presented as LS mean (90% CI).