Luo X, Hou L, Liang L, et al. Long-Acting Pegylated Recombinant Human Growth Hormone (Jintrolong(R)) for Children with Growth Hormone Deficiency: Phase II and Phase III Multicenter, Randomized Studies. Eur J Endocrinol. http://www.eje-online.org/content/early/2017/05/30/EJE-16-0905
OBJECTIVE: We assessed the efficacy and safety of a weekly PEGylated human growth hormone (PEG-rhGH) (Jintrolong(R)) vs. daily rhGH for children with growth hormone deficiency (GHD). DESIGN: Phase II and III, multicenter, open-label, randomized controlled trials.
METHODS: 108 and 343 children with treatment-naive GHD from 6 hospitals in China were enrolled in the phase II and III studies, respectively. Patients in the phase II study were randomized 1:1:1 to weekly Jintrolong(R) (0.1 mg.kg-1.wk-1 PEG-rhGH complex), weekly Jintrolong(R) (0.2 mg.kg-1.wk-1 PEG-rhGH complex) or daily rhGH (0.25 mg.kg-1.wk-1) for 25 weeks.
Patients in the phase III study were randomized in a 2:1 ratio to weekly Jintrolong(R) (0.2 mg.kg-1.wk-1) or daily rhGH (0.25 mg.kg-1.wk-1) for 25 weeks. The primary endpoint for both studies was height velocity (HV) increase at the end of treatment. Other growth-related parameters, safety and compliance were also monitored.
RESULTS: The phase II study established the preliminary efficacy, safety and recommended dose of Jintrolong(R) PEG-rhGH. In the phase III study, we demonstrated significantly greater HV increases in patients receiving Jintrolong(R) treatment (from 2.26+/-0.87 cm/y to 13.41+/-3.72 cm/y) vs. daily rhGH (from 2.25+/-0.82 cm/y to 12.55 +/- 2.99 cm/y) at the end of treatment (P<0.05).
Additionally, significantly greater improvement in the height standard deviation scores was associated with Jintrolong(R) throughout the treatment (P<0.05). Adverse event rates and treatment compliance were comparable between the two groups.
CONCLUSION: Jintrolong(R) PEG-rhGH at a dose of 0.2 mg.kg-1.wk-1 for 25 weeks is effective and safe for GHD treatment and is non-inferior to daily rhGH.
