Recombinant growth hormones Eutropin and Genotropin were found to produce similar improvements in growth, body fat composition, and motor and cognitive development in infants with Prader-Willi syndrome (PWS), a study has found.
The results also suggest that Eutropin is a safe growth hormone to treat infants with PWS.
The study, “Effects of recombinant human growth hormone treatment on growth, body composition, and safety in infants or toddlers with Prader-Willi syndrome: a randomized, active-controlled trial,” was published in the Orphanet Journal of Rare Diseases.
Recombinant growth hormone — a version of human growth hormone that’s manufactured in the lab — is a standard treatment for children with PWS, because it increases their growth and psychomotor development, and helps control obesity, which is a common side effect of the condition.
The most common form of recombinant growth hormone is Genotropin, which is developed by Pfizer. However, other options not as widely studied are also available in the market, such as LG Chem‘s Eutropin. Both Genotropin and Eutropin are therapies based on the compound somatropin (a growth hormone).
Most PWS children start receiving growth hormone treatment when they are older than 2, but previous studies have suggested that it is safe and more beneficial to start the treatment in early infancy.
In this study, researchers in South Korea performed a randomized, open-label Phase 3 trial (NCT02204163) to evaluate the safety and efficacy of recombinant growth hormone in infants with PWS younger than 2. They also compared the effects of Eutropin to those of Genotropin. Both therapies were given at a dose of 0.24 mg/kg/week, six times per week, for one year.
The study was conducted in three medical centers in South Korea, from October 2014 to December 2017, and recruited 34 infants diagnosed with PWS who had not received growth hormone for at least six months before the start of the trial. Of these, 17 received Eutropin, and 17 received Genotropin.
The researchers evaluated the effects of both formulations on the children’s growth, percentage of body fat, and motor and cognitive development over one year.
The mean age at the beginning of the trial was 4.8 months in the Eutropin group, and 8.04 months in the Genotropin group. Therefore, the study measured the changes in growth and development, accounting for the age difference between the groups.
Results showed that participants in both groups experienced a similar significant increase in height and percentage of lean body mass.
Both groups also showed a similar decrease in the percentage of body fat, with those treated with Eutropin losing a mean of 8.12% in body fat and those treated with Genotropin losing 7.48% of body fat.
Both treatments also led to a significant improvement in motor and cognitive development, which became apparent six months after starting the study.
“Notably, the younger the children were at the moment of GHT [growth hormone therapy] initiation, the greater the improvement in psychomotor development. This result suggests the importance of starting GHT before the age of 2 years, which is a critical period of child neurodevelopment,” the researchers wrote.
Adverse events were similar in both groups, and were mostly mild or moderate. The most common was upper respiratory tract infection, which was found not to be treatment-related.
Overall, 15 participants experienced 28 serious adverse events, mostly pneumonia or bronchiolitis. The incidence rate was similar between the two groups.
Among 15 adverse treatment reactions, the most frequent was hypothyroidism — a reduced function of the thyroid gland — with three incidents in the Eutropin group, and one in the Genotropin group.
The team concluded that “treatment with 0.24 mg/kg/week Eutropin administered subcutaneously for 52 weeks in infants and toddlers with PWS showed its efficacy in improving growth, including the increase in height, body composition, and motor and cognitive development.”
The data “also confirmed that Eutropin was generally comparable with Genotropin,” and that the therapies had a similar safety profile, the researchers wrote.
“Thus, Eutropin is considered to safely improve the symptoms of pediatric patients with PWS,” they said.
Of note, two of the authors are employed by LG Chem, which also funded the study.