RT journal article
T1 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
A1 Loche, Sandro
A1 Kanumakala, Shankar
A1 Backeljauw, Philippe
A1 Schwab, Karl Otfried
A1 Lechuga Sancho, Alfonso María
A1 Esmael, Altaher
A1 Urosevic, Dragan
A1 Boldea, Anca
A1 Zabransky, Markus
A2 Materno-Infantil y Radiología
K1 Omnitrope
K1 PATRO Children
K1 growth hormone
K1 pediatrics
K1 growth hormone deficiency
K1 small for gestational age
AB Purpose: Omnitrope® (somatropin) was approved as a biosimilar recombinant human growth hormone (rhGH) in 2006. Here, wereport final data from the PAtients TReated with Omnitrope® (PATRO) Children study, a post-marketing surveillance study designed tomonitor the long-term safety and effectiveness of this treatment in pediatric patients.Methods: The study population included all pediatric patients treated with Omnitrope® (biosimilar rhGH), administered via daily injection,in routine clinical practice. The primary objective was to assess long-term safety, with effectiveness assessed as a secondary objective.Results: In total, 7359 patients were enrolled and treated in the PATRO Children study; 86.0% were treatment-naïve at baseline.Growth hormone deficiency was the most frequent indication (57.9%), followed by patients born small for gestational age (SGA;26.6%). The mean (SD) duration of exposure to biosimilar rhGH was 3.66 years (2.39). A total of 16,628 adverse events (AEs) werereported in 3981 (54.1%) patients, most of which were mild/moderate. AEs suspected to be treatment related occurred in 8.3% ofpatients, most frequently headache (1.6%), injection-site pain (1.1%), or injection-site hematoma (1.1%). The incidence rate (IR) oftype 2 diabetes mellitus was 0.11 per 1000 person-years (PY) across all patients, and 0.13 per 1000 PY in patients born SGA. The IRof newly diagnosed primary malignancies was 0.22 per 1000 PY across all patients. In the 6589 patients included in the effectivenesspopulation, a sustained catch-up growth was observed across all indications. After 5 years of treatment, height SDS increased frombaseline by a median (range) of +1.79 (–3.7 to 6.2) in treatment-naïve patients and +0.73 (–1.4 to 3.7) in pretreated patients.Conclusion: This final analysis of the PATRO Children study indicates that biosimilar rhGH is well tolerated and effective in realworld clinical practice. These data are consistent with the well-characterized safety profile of rhGH treatment in pediatric patients.
PB Dovepress
SN 1177-8881
YR 2024
FD 2024-03-02
LK http://hdl.handle.net/10498/32750
UL http://hdl.handle.net/10498/32750
LA eng
DS Repositorio Institucional de la Universidad de Cádiz
RD 10-nov-2026