heiGHt study design
heiGHt was a randomized, open-label, active-controlled, phase 3 study that compared the efficacy, safety, and tolerability of once-weekly SKYTROFA® versus once-daily somatropin in children with GHD1,2*
*Annualized height velocity (AHV) at week 52 was the primary endpoint.2
Higher mean AHV versus daily somatropin
SKYTROFA demonstrated higher AHV in a phase 3 clinical trial of 161 treatment-naïve pediatric patients with GHD1,2
Mean AHV at week 52: once-weekly SKYTROFA versus daily somatropin1,2†‡
- The change in mean bone age from baseline to week 52 was similar with SKYTROFA and daily somatropin,‡ and the observed mean BMI SDS remained within normal range‡ for both groups2,3
Sustained growth was achieved with SKYTROFA in treatment-naïve patients2
Patients treated with SKYTROFA had a greater increase from baseline in height SDS§ compared with patients treated with a daily somatropin at week 52 (1.10 versus 0.96, respectively)2||
Established safety profile
The safety profile of SKYTROFA has been established in pediatric patients aged 1 year and older who weigh at least 11.5 kg1
Low immunogenicity, with no neutralizing antibodies detected2
Only 6.7% (7 of 105) of patients showed detectable binding antibodies2
- Some patients taking SKYTROFA experienced mild injection-site reactions2
- Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products1
AEs reported in ≥ 5% of SKYTROFA-treated pediatric patients and more frequently than in daily somatropin-treated# pediatric patients (52 weeks of treatment)1
AEs | SKYTROFA (n = 105) |
Daily somatropin (n = 56) |
---|---|---|
n (%) | n (%) | |
Viral infection | 16 (15%) | 6 (11%) |
Pyrexia | 16 (15%) | 5 (9%) |
Cough | 11 (11%) | 4 (7%) |
Nausea and vomiting | 11 (11%) | 4 (7%) |
Hemorrhage¶ | 7 (7%) | 1 (2%) |
Diarrhea | 6 (6%) | 3 (5%) |
Abdominal pain | 6 (6%) | 2 (4%) |
Athralgia and arthritis# | 6 (6%) | 1 (2%) |
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