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Safety and effectiveness of a somatropin biosimilar in children requiring growth hormone treatment: second analysis of the PATRO Children study Italian cohort

التفاصيل البيبلوغرافية
العنوان: Safety and effectiveness of a somatropin biosimilar in children requiring growth hormone treatment: second analysis of the PATRO Children study Italian cohort
المؤلفون: 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
المساهمون: 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.
المصدر: Journal of Endocrinological Investigation. 44:493-503
بيانات النشر: Springer Science and Business Media LLC, 2020.
سنة النشر: 2020
مصطلحات موضوعية: 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
الوصف: 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.
وصف الملف: STAMPA
تدمد: 1720-8386
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c0e76530b9df1d4fa511a05b4faa9b8c
https://doi.org/10.1007/s40618-020-01331-4
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....c0e76530b9df1d4fa511a05b4faa9b8c
قاعدة البيانات: OpenAIRE
الوصف
تدمد:17208386