Long-term safety and efficacy of the recombinant human growth hormone omnitrope® in the treatment of Spanish growth hormone deficient children: Results of a phase III study

Abstract

At a dose of 0.03 mg/kg/day, Omnitrope was safe, effective, and well tolerated during long-term treatment of children with GHD.

Long-term safety and efficacy of Omnitrope®, a somatropin biosimilar, in children requiring growth hormone treatment: Italian interim analysis of the PATRO Children study

“…Similar to investigational studies, Omnitrope® treatment was associated with an improvement in both HSDS and HVSDS in paediatric patients with GHD [9, 14]. As expected, patients who had received rhGH pre-treatment had a baseline HSDS higher than those who were naïve to rhGH, but the responses followed the same trend for the two populations.…”

“…Some studies have suggested a link between rhGH treatment and the development of diabetes [19], whilst other studies have not established the same relationship [9, 20]. More specifically, children born SGA may be at increased risk of developing insulin resistance and type 2 diabetes [21] and there is concern that rhGH may amplify this risk.…”

“…Results from pivotal phase III studies of Omnitrope® have demonstrated that Omnitrope® is safe and effective in infants, children and adolescents with GHD [9, 14]; however, more real-world data of Omnitrope® in pediatric patients are required to consolidate the phase III outcomes in clinical practice. To address this, the PAtients TReated with Omnitrope® (PATRO) Children study was initiated.…”

Design of, and first data from, PATRO Children, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope® in children requiring growth hormone treatment

“…Interventional studies have already demonstrated that somatropin is efficacious and safe in infants, children and adolescents with GHD [Romer et al 2009;López-Siguero et al 2011]. Based on our preliminary data, the efficacy of somatropin in PATRO Children is consistent with that observed in previous phase III studies with somatropin in patients with GHD, and the product also appears to be effective in other indications that were not required to be studied as part of the product registration clinical trial programme (such as TS, CRI, SGA and PWS).…”

Ten years' clinical experience with biosimilar human growth hormone: a review of efficacy data

“…A third study assessed the efficacy and safety of long-term (up to 5 years) treatment with biosimilar rhGH 3.3 mg/mL liquid formulation in children with GHD (n=70) 7. After 4 years, significant increases (compared with baseline) were recorded in mean height (31.1 cm [95% CI: 29.6, 32.6]), HSDS (1.42 [95% CI: 1.13, 1.70]), HV (2.4 cm [95% CI: 1.7, 3.1]), and HVSDS (3.5 [95% CI: 2.7, 4.3]) values.…”