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Humatrope

Clinical Pharmacology
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Clinical Pharmacology

Humatrope

Study/Group

Study Designa

N at Adult Height

GH Age (yr)

Estrogen Age (yr)

GH Duration (yr)

Adult Height Gain (cm)b

GDCT

RCT

27

11.7

13

4.7

5.4

85-023   MHT

17

9.1

15.2

7.6

7.4

85-044: A* MHT

29

9.4

15

6.1

8.3

  B*  

26

9.6

12.3

5.6

5.9

  C*  

51

12.7

13.7

3.8

5

GDCI   RDT

31

11.1

8-13.5

5.3

~5c

a RCT: randomized controlled trial; MHT: matched historical controlled trial; RDT: randomized dose-response trial.

b Analysis of covariance vs. controls.

c Compared with historical data.

* A: GH age <11 yr, estrogen age 15 yr.

B: GH age <11 yr, estrogen age 12 yr.

C: GH age >11 yr, estrogen at month 12.

Effect of Humatrope Treatment in Pediatric Patients with Idiopathic Short Stature

Two randomized, multicenter trials, 1 placebo-controlled and 1 dose-response, were conducted in pediatric patients with idiopathic short stature, also called non-growth hormone-deficient short stature. The diagnosis of idiopathic short stature was made after excluding other known causes of short stature, as well as growth hormone deficiency. Limited safety and efficacy data are available below the age of 7 years. No specific studies have been conducted in pediatric patients with familial short stature or who were born small for gestational age (SGA).

The placebo-controlled study enrolled 71 pediatric patients (55 males, 16 females) 9 to 15 years old (mean age 12.38 ± 1.51 years), with short stature, 68 of whom received study drug. Patients were predominately Tanner I (45.1%) and Tanner II (46.5%) at baseline.

In this double-blind trial, patients received subcutaneous injections of either Humatrope 0.222 mg/kg/wk or placebo. Study drug was given in divided doses 3 times per week until height velocity decreased to ≤1.5 cm/year ("final height"). Thirty-three subjects (22 Humatrope, 11 placebo) had final height measurements after a mean treatment duration of 4.4 years (range 0.11-9.08 years).

The Humatrope group achieved a mean final height Standard Deviation Score (SDS) of -1.8 (Table 4). Placebo-treated patients had a mean final height SDS of -2.3 (mean treatment difference = 0.51, p=0.017). Height gain across the duration of the study and final height SDS minus baseline predicted height SDS were also significantly greater in Humatrope-treated patients than in placebo-treated patients (Table 4 and 5). In addition, the number of patients who achieved a final height above the 5th percentile of the general population for age and sex was significantly greater in the Humatrope group than the placebo group (41% vs. 0%, p<0.05), as was the number of patients who gained at least 1 SDS unit in height across the duration of the study (50% vs. 0%, p<0.05).

Table 4: Baseline Height Characteristics and Effect of Humatrope on Final Heighta
Brand Name: Humatrope
Generic Name: Somatropin rDNA Origin

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