Safety and effectiveness of a somatropin biosimilar in children requiring growth hormone treatment: second analysis of the PATRO Children study Italian cohort
| Autor: | G. Bona, Nella Augusta Greggio, Lorenzo Iughetti, H. Zouater, L. Ragusa, Laura Guazzarotti, P. Fedeli, Gabriella Pozzobon, Claudia Giavoli, P. Gallinari, Franco Antoniazzi, C. Zecchino, Gianluca Tornese, Luca Persani, Stefano Zucchini, Stefano Stagi, Roberta Minelli, Tommaso Aversa, Laura Perrone |
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| Přispěvatelé: | Iughetti, L., Antoniazzi, F., Giavoli, C., Bona, G., Aversa, T., Greggio, N. A., Guazzarotti, L., Minelli, R., Perrone, L., Persani, L., Pozzobon, G., Ragusa, L., Stagi, S., Tornese, G., Zecchino, C., Gallinari, P., Zouater, H., Fedeli, P., Zucchini, S. |
| Rok vydání: | 2020 |
| Předmět: |
Male
Omnitrope Pediatrics medicine.medical_specialty Abdominal pain Adolescent Endocrinology Diabetes and Metabolism Recombinant human growth hormone 030209 endocrinology & metabolism ® Adolescents Impaired glucose tolerance 03 medical and health sciences 0302 clinical medicine Endocrinology Product Surveillance Postmarketing medicine Clinical endpoint Humans Children Infants Pediatric Longitudinal Studies Child Adverse effect Biosimilar Pharmaceuticals Growth Disorders Human Growth Hormone business.industry Infant Prognosis medicine.disease Growth hormone treatment Clinical trial 030220 oncology & carcinogenesis Cohort Female Observational study medicine.symptom business Follow-Up Studies |
| Zdroj: | Journal of Endocrinological Investigation. 44:493-503 |
| ISSN: | 1720-8386 |
| DOI: | 10.1007/s40618-020-01331-4 |
| Popis: | Purpose: To investigate the long-term safety (primary endpoint) and effectiveness (secondary endpoint) of the somatropin biosimilar Omnitrope®. Methods: 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. Results: 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). Conclusions: 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. |
| Databáze: | OpenAIRE |
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