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.
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 / Iughetti, L., Antoniazzi, F., Giavoli, C., Bellone, S., Aversa, T., Guazzarotti, L., Street, M.E., Miraglia Del Giudice, E., Persani, L., Pozzobon, G., Ragusa, L., Stagi, S., Tornese, G., Zecchino, C., Mameli, C., Zecchi, E., Fedeli, P., Zabransky, M., Lucaccioni, L., Zucchini, S.. - In: ENDOCRINE. - ISSN 1559-0100. - 87:3(2025), pp. 55.933-55.942. [10.1007/s12020-024-04090-x]
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
Street M. E.Membro del Collaboration Group
;
2025-01-01
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
