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Humatrope

Clinical Pharmacology
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Clinical Pharmacology

Humatrope

Humatrope (n=22) Mean (SD)

Placebo (n=11) Mean (SD)

Treatment Effect Mean (95% CI)

p-value Baseline height SDS

-2.7 (0.6)

-2.75(0.6)

0.77

BPH SDS

-2.1 (0.7)

-2.3 (0.8)

 

0.53

Final height SDSb

-1.8 (0.8)

-2.3 (0.6)

0.51(0.10,0.92)

0.017

FH SDS - baseline height SDS

0.9 (0.7)

0.4 (0.2)

0.51(0.04,0.97)

0.034

FH SDS - BPH SDS

0.3 (0.6)

-0.1 (0.6)

0.46(0.02,0.89)

0.043

a For final height population.

b Between-group comparison was performed using analysis of covariance with baseline predicted height SDS as the covariant. Treatment effect is expressed as least squares mean (95% CI).

Abbreviations: FH=final height; SDS=standard deviation score; BPH= baselinepredicted height; CI= confidence interval.< /p>

The dose-response study included 239 pediatric patients (158 males, 81 females), 5 to 15 years old, (mean age 9.8 ± 2.3 years). Mean baseline characteristics included: a height SDS of -3.21 (±0.70), a predicted adult height SDS of -2.63 (±1.08), and a height velocity SDS of -1.09 (±1.15). All but 3 patients were Tanner I. Patients were randomized to one of three Humatrope treatment groups: 0.24 mg/kg/wk; 0.24 mg/kg/wk for 1 year, followed by 0.37 mg/kg/wk; and 0.37 mg/kg/wk.

The primary hypothesis of this study was that treatment with Humatrope would increase height velocity during the first 2 years of therapy in a dose-dependent manner. Additionally, after completing the initial 2-year dose-response phase of the study, 50 patients were followed to final height.

Patients receiving 0.37 mg/kg/wk had a significantly greater increase in mean height velocity after 2 years of treatment than patients receiving 0.24 mg/kg/wk (4.04 vs. 3.27 cm/year, p=0.003). The mean difference between final height and baseline predicted height was 7.2 cm for patients receiving 0.37 mg/kg/wk and 5.4 cm for patients receiving 0.24 mg/kg/wk (Table 5). While no patient had height above the 5th percentile in any dose group at baseline, 82% of the patients receiving 0.37 mg/kg/wk and 47% of the patients receiving 0.24 mg/kg/wk achieved a final height above the 5th percentile of the general population height standards (p=NS).

Table 5: Final Height Minus Baseline Predicted Height: Idiopathic Short Stature Trials

Placebo-controlled Trial 3x per week dosing

Dose Response Trial 6x per week dosing
Brand Name: Humatrope
Generic Name: Somatropin rDNA Origin

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