Table 3.
Dose | All subjects | PEM-positive peak GH ≥5 ng/mL and baseline IGF-I > 30 ng/mL | PEM-negative peak GH <5 ng/mL and/or baseline IGF-I ≤ 30 ng/mL | P value PEM-positive vs PEM-negative a |
---|---|---|---|---|
LUM-201 | 6.0 (1.9) | 6.2 (1.8) | 5.8 (2.1) | 0.60 |
0.4 mg/kg/day | n = 22 | n = 12 | n = 10 | |
LUM-201 | 6.9 (1.9) | 7.7 (1.3) | 5.4 (2.0) | 0.0025 |
0.8 mg/kg/day | n = 24 | n = 15 | n = 9 | |
rhGH | 11.4 (4.0) | 8.8 (1.8) | 14.0 (4.1) | 0.0013 |
0.3 mg/kg/week | n = 20 | n = 11 | n = 9 |
Abbreviations: AHV, annualized height velocity; GH, growth hormone; IGF-I, insulin-like growth factor I; PEM, predictive enrichment marker; rhGH, recombinant human growth hormone.
aPaired t-tests were used to test for statistical significance.