TY - JOUR
T1 - Long-term safety and effectiveness of a somatropin biosimilar (Omnitrope®) in children requiring growth hormone therapy: analysis of final data of Italian patients enrolled in the PATRO children study
AU - Iughetti, L
AU - Antoniazzi, F
AU - Giavoli, C
AU - BELLONE, Simonetta
AU - Aversa, T
AU - Guazzarotti, L
AU - ME, Street
AU - Miraglia, Del Giudice E
AU - Persani, L
AU - Pozzobon, G
AU - Ragusa, L
AU - Stagi, S
AU - Tornese, G
AU - Zecchino, C
AU - Mameli, C
AU - Zecchi, E
AU - Fedeli, P
AU - Zabransky, M
AU - Lucaccioni, L
AU - Zucchini, S
PY - 2024
Y1 - 2024
N2 - Purpose
Omnitrope® (a somatropin biosimilar), used to treat growth disturbances, is considered to have a good safety profile in children. Here, we present the analysis of final data of the Italian cohort of the PAtients TReated with Omnitrope® (PATRO) Children study.
Methods
This multicenter, open-label, longitudinal, post-marketing surveillance study enrolled eligible children during 2010–2018. The primary objective was to assess the long-term safety of Omnitrope® by recording all adverse events (AEs), serious AEs, and adverse drug reactions (ADRs). A secondary objective was to evaluate the long-term effectiveness of Omnitrope® using height measurements.
Results
A total of 375 patients were included in the Italian cohort of the PATRO Children study. After a mean ± standard deviation (SD) follow-up duration of 40.9 ± 24.6 months, 607 AEs were reported in 58.4% of patients, mostly of mild (52.5%) or moderate (15.7%) severity. The most common AEs were headache (11.7%), elevated insulin-like growth factor (IGF)-1 (4.8%), abdominal pain (4.3%), and pyrexia (3.7%). Sixty-seven ADRs occurred in 52 patients (13.9%); the most common ADRs were elevated IGF-1 (3.5%) and insulin resistance (2.9%). Mean ± SD height standard deviation scores in treatment-naïve patients increased from −2.5 ± 0.7 at baseline (n = 318) to −1.3 ± 0.7 at 5 years (n = 56) and to −0.8 ± 0.7 at 7.5 years (n = 13).
Conclusions
This final analysis extends the interim analysis findings from the PATRO Children study and confirms the long-term safety and effectiveness of Omnitrope® in Italian pediatric patients with growth disturbances.
AB - Purpose
Omnitrope® (a somatropin biosimilar), used to treat growth disturbances, is considered to have a good safety profile in children. Here, we present the analysis of final data of the Italian cohort of the PAtients TReated with Omnitrope® (PATRO) Children study.
Methods
This multicenter, open-label, longitudinal, post-marketing surveillance study enrolled eligible children during 2010–2018. The primary objective was to assess the long-term safety of Omnitrope® by recording all adverse events (AEs), serious AEs, and adverse drug reactions (ADRs). A secondary objective was to evaluate the long-term effectiveness of Omnitrope® using height measurements.
Results
A total of 375 patients were included in the Italian cohort of the PATRO Children study. After a mean ± standard deviation (SD) follow-up duration of 40.9 ± 24.6 months, 607 AEs were reported in 58.4% of patients, mostly of mild (52.5%) or moderate (15.7%) severity. The most common AEs were headache (11.7%), elevated insulin-like growth factor (IGF)-1 (4.8%), abdominal pain (4.3%), and pyrexia (3.7%). Sixty-seven ADRs occurred in 52 patients (13.9%); the most common ADRs were elevated IGF-1 (3.5%) and insulin resistance (2.9%). Mean ± SD height standard deviation scores in treatment-naïve patients increased from −2.5 ± 0.7 at baseline (n = 318) to −1.3 ± 0.7 at 5 years (n = 56) and to −0.8 ± 0.7 at 7.5 years (n = 13).
Conclusions
This final analysis extends the interim analysis findings from the PATRO Children study and confirms the long-term safety and effectiveness of Omnitrope® in Italian pediatric patients with growth disturbances.
UR - https://iris.uniupo.it/handle/11579/195723
U2 - 10.1007/s12020-024-04090-x
DO - 10.1007/s12020-024-04090-x
M3 - Article
SN - 1355-008X
JO - Endocrine
JF - Endocrine
ER -