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
Year: 2024
Type: article
Abstract: 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. 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. 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). 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.
Source: Endocrine
Authors: Lorenzo Iughetti, Franco Antoniazzi, Claudia Giavoli, Simonetta Bellone, Tommaso Aversa, Laura Guazzarotti, Maria Elisabeth Street, Emanuele Miraglia del Giudice, Luca Persani, Gabriella Pozzobon, Letizia Ragusa, Stefano Stagi, Gianluca Tornese, Clara Zecchino, Chiara Mameli, Emiliano Zecchi, Paolo Fedeli, Markus Zabransky, Laura Lucaccioni, Stefano Zucchini
Institutions: University of Modena and Reggio Emilia, University of Verona, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi del Piemonte Orientale “Amedeo Avogadro”, University of Messina, University of Padua, University of Parma, Ospedale di Parma, University of Campania "Luigi Vanvitelli", University of Milan, IRCCS Istituto Auxologico Italiano, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Meyer Children's Hospital, University of Florence, University of Trieste, IRCCS Materno Infantile Burlo Garofolo, Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari, Ospedale dei Bambini Vittore Buzzi, Hexal (Germany), University of Bologna
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,790
OpenAlex ID: W4404858318