To investigate the long-term safety (primary endpoint) and effectiveness (secondary endpoint) of the somatropin biosimilar Omnitrope®.
PATRO Children is an ongoing, multicenter, observational, post-marketing surveillance study. Children who received Omnitrope® for any indication were included. Adverse events (AEs) were evaluated in all study participants. Auxological data, including height standard deviation scores (HSDS) and height velocity standard deviation scores (HVSDS), were used to assess effectiveness. In this snapshot analysis, data from the Italian subpopulation up to August 2017 were reported.
A total of 291 patients (mean age 10.0 years, 56.0% male) were enrolled at 19 sites in Italy. The mean duration of Omnitrope® treatment was 33.1 ± 21.7 months. There were 48 AEs with a suspected relationship to the study drug (as reported by the investigator) that occurred in 35 (12.0%) patients, most commonly headache, pyrexia, arthralgia, insulin-like growth factor above normal range, abdominal pain, pain in extremity and acute gastroenteritis. There were no confirmed cases of type 1 or type 2 diabetes; however, two patients (0.7%) had impaired glucose tolerance that was considered Omnitrope® related. The mean HSDS increased from − 2.41 ± 0.73 at baseline (n = 238) to − 0.91 ± 0.68 at 6.5 years (n = 10). The mean HVSDS increased from − 1.77 ± 1.38 at baseline (n = 136) to 0.96 ± 1.13 at 6.5 years (n = 10).
In this sub-analysis of PATRO Children, Omnitrope® appeared to have acceptable safety and effectiveness in the treatment of in Italian children, which was consistent with the earlier findings from controlled clinical trials.
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The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Medical writing assistance in drafting the outline and first draft of this manuscript was provided by Matt Shirley and Mimi Chan, PhD, of Springer Healthcare Communications, respectively. This medical writing assistance was funded by Sandoz, Italy.
The study was funded by Sandoz, Italy.
Conflict of interest
LI has participated in Advisory Boards for Eli Lilly, Italy and Novo Nordisk, Italy; FA has received honoraria from Eli Lilly, Novo Nordisk and Ipsen and research funding from Merck Serono; CG, TA, NAG, LG, RM, L Perrone, LR, SS, and GT have no conflict of interest to declare; L Persani has been an invited speaker for Sandoz and Merck-Serono, and has received unconditional research funds from Novartis, IBSA and Merck-Serono; GB has received honoraria from Ferring, Novo, Serono, Lilly, Sandoz; CZ has received honoraria from Sandoz, Novo, Medtronic; HZ is an employee of Sandoz Biopharmaceutical c/o HEXAL AG, Germany; PG and PF are employees of Sandoz S.p.A, Milan, Italy; SZ has been a member of expert committees for Eli Lilly Diabetes, Italy, and Roche Diagnostics.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (Comitato Etico Indipendente dell’Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, n°120/2007/O/Oss) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from the parents or legal guardians of all individual participants included in the study.
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Iughetti, L., Antoniazzi, F., Giavoli, C. et al. Safety and effectiveness of a somatropin biosimilar in children requiring growth hormone treatment: second analysis of the PATRO Children study Italian cohort. J Endocrinol Invest 44, 493–503 (2021). https://doi.org/10.1007/s40618-020-01331-4
- Recombinant human growth hormone