A recent study found Omnitrope® (somatropin) to be effective and safe in pediatric patients over long term. The findings from the PATRO Children study were published in the journal of Drug Design, Development and Therapy.
Amidst the ongoing concerns over the safety and effectiveness of pediatric treatments, Omnitrope® (somatropin) which is a biosimilar recombinant human growth hormone (rhGH) showed positive outcomes. The latest data from the PATRO Children study highlights its remarkable performance in real-world clinical settings.
The PATRO Children study was conducted to monitor the long-term safety and efficacy of Omnitrope® and enrolled a substantial cohort of 7359 pediatric patients, majority of whom were treatment-naïve. The results underline the well-tolerated nature of this treatment with a notable 86.0% of patients being new to therapy at the onset of the study.
Growth hormone deficiency was found to be the predominant indication for treatment, that was followed closely by patients born small for gestational age (SGA). Throughout the study duration, the patients expressed a sustained catch-up growth with the standard deviation scores (SDS) of height significantly improving over time.
Despite the concerns inherent to any therapeutic intervention, the adverse events (AEs) associated with Omnitrope® were largely mild to moderate in severity that reaffirms its favorable safety profile. A mere 8.3% of patients experienced AEs suspected to be treatment-related, with commonly reported issues including headaches and injection-site discomfort. The low incidence rates of significant complications such as type 2 diabetes mellitus and primary malignancies further consolidated the safety credentials of this treatment.
Source:
Loche, S., Kanumakala, S., Backeljauw, P., Schwab, K., Lechuga-Sancho, A., Esmael, A., Urosevic, D., Boldea, A., & Zabransky, M. (2024). Safety and Effectiveness of a Biosimilar Recombinant Human Growth Hormone in Children Requiring Growth Hormone Treatment: Analysis of Final Data from PATRO Children, an International, Post-Marketing Surveillance Study. In Drug Design, Development and Therapy: Vol. Volume 18 (pp. 667–684). Informa UK Limited. https://doi.org/10.2147/dddt.s440009