Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV Trial

Figures & data

Figure 1 Subject disposition.

Table 1 Baseline Characteristics (Per Protocol Set)

	N=107
Age (years)
Mean (SD)	9.4 (2.8)
Range	4–15
Gender
Male, n (%)	52 (48.6)
Female, n (%)	55 (51.4)
Indication for rhGH treatment
Growth hormone deficiency, n (%)	30 (28.0)
Turner syndrome, n (%)	1 (0.9)
Chronic renal failure, n (%)	0 (0.0)
Small for gestational age, n (%)	14 (13.1)
Idiopathic short stature, n (%)	62 (57.9)
Duration since diagnosis (months), mean (SD)	26.3 (25.9)
Reusable device used for 3 months prior to enrollment
Electronic device with liquid cartridge, n (%)	46 (43.0)
Pen with dual-chamber cartridge, n (%)	45 (42.1)
Pen with liquid cartridge, n (%)	16 (15.0)
Duration of using the previous reusable device, mean months (SD)	13.0 (16.2)

Abbreviations: rhGH, recombinant human growth hormone; SD, standard deviation.

Table 2 Ease of Use and Preference for the Disposable Pen by the Previous Reusable Device (Per Protocol Set)

	Electronic Device with Liquid Cartridge (N=46)	Pen with Dual-Chamber Cartridge (N=45)	Pen with Liquid Cartridge (N=16)
Ease of use
Mean (SD)	7.60 (2.20)	8.40 (2.00)	7.20 (2.60)
95% CI	(6.97, 8.29)	(7.77, 8.99)	(5.82, 8.55)
Preference
Disposable pen, n (%)	35 (76.1)	36 (80.0)	10 (62.5)
Previous reusable device, n (%)	11 (23.9)	9 (20.0)	6 (37.5)
Neither is preferred, n (%)	0 (0.0)	0 (0.0)	0 (0.0)
No preference or prefer the disposable pen, n (%)	35 (76.1)	36 (80.0)	10 (62.5)
95% CI	(63.8, 88.4)	(68.3, 91.7)	(38.8, 86.2)

Abbreviations: CI, confidence interval; SD, standard deviation.

Figure 2 Ease of use based on each injection step (Per protocol set). *p<0.05, p-value was obtained from Bhapkar’s test.

Figure 3 Injection preparation time (Per protocol set). The difference of the injection preparation time between the previous reusable device and the disposable pen was significant by Bhapkar’s test (p=0.0023).

Figure 4 Benefits of the disposable pen (Per protocol set).

Notes: Multiple choices were allowed for each subject.

Figure 5 Fear of the needle of the reusable device and the disposable pen (Per protocol set). The difference of the fear of the needle between the previous reusable device and the disposable pen was significant by Bhapkar’s test (p=0.0025).

Figure 6 Pain and discomfort at the injection site (Safety set). The differences of the pain and discomfort at the injection site between the previous reusable device and the disposable pen were significant by Bhapkar’s test (p<0.05).