Long-term safety and efficacy of Omnitropein adults with growth hormone deficiency

Italian interim analysis of the PATRO Adults study

D Ferone, E Profka, V Gasco, M R Ambrosio, A Colao, C Di Somma, E Puxeddu, G Arnaldi, C Pagano, E Zecchi, A Pietropoli, P Beck-Peccoz

Research output: Contribution to journalArticle

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Abstract

PURPOSE: To report the long-term effectiveness and safety of the recombinant human growth hormone Omnitrope®, a somatropin biosimilar to Genotropin®, in Italian patients with growth hormone deficiency (GHD) enrolled in the PATRO Adults study.

METHODS: The PATRO Adults study is an ongoing observational, longitudinal, non-interventional global post-marketing surveillance study, conducted in several European countries. The primary endpoint is long-term safety; secondary endpoints include the effectiveness of Omnitrope®, which was assessed using serum insulin-like growth factor-1 levels, body composition, bone mineral density and lipid levels. Here we report the data from the Italian patients enrolled in the study.

RESULTS: Sixty-seven patients (mean age 50.4 years, 61.2% male) have been enrolled and have received a mean 45.4 ± 24.3 months of Omnitrope®. A total of 55.2% of patients were reported to have experienced adverse events (AEs), including arthralgia, myalgia, abdominal distension and hypoaesthesia, and 4.5% had adverse drug reactions. Fourteen serious AEs have been recorded; none of these are considered related to the study drug. The effectiveness of Omnitrope®was similar to other available somatropin preparations.

CONCLUSIONS: This study confirms the effectiveness and safety of Omnitrope®in adult patients with GHD in Italy. However, due to the limited size of the study population, these results need to be further confirmed by the global PATRO Adults study.

Original languageEnglish
Pages (from-to)669-678
Number of pages10
JournalJournal of Endocrinological Investigation
Volume40
Issue number6
DOIs
Publication statusPublished - Jun 2017

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Human Growth Hormone
Growth Hormone
Safety
Biosimilar Pharmaceuticals
Hypesthesia
Myalgia
Arthralgia
Somatomedins
Population Density
Body Composition
Marketing
Drug-Related Side Effects and Adverse Reactions
Bone Density
Italy
Lipids
Serum
Pharmaceutical Preparations

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Long-term safety and efficacy of Omnitropein adults with growth hormone deficiency : Italian interim analysis of the PATRO Adults study. / Ferone, D; Profka, E; Gasco, V; Ambrosio, M R; Colao, A; Di Somma, C; Puxeddu, E; Arnaldi, G; Pagano, C; Zecchi, E; Pietropoli, A; Beck-Peccoz, P.

In: Journal of Endocrinological Investigation, Vol. 40, No. 6, 06.2017, p. 669-678.

Research output: Contribution to journalArticle

Ferone, D, Profka, E, Gasco, V, Ambrosio, MR, Colao, A, Di Somma, C, Puxeddu, E, Arnaldi, G, Pagano, C, Zecchi, E, Pietropoli, A & Beck-Peccoz, P 2017, 'Long-term safety and efficacy of Omnitropein adults with growth hormone deficiency: Italian interim analysis of the PATRO Adults study', Journal of Endocrinological Investigation, vol. 40, no. 6, pp. 669-678. https://doi.org/10.1007/s40618-016-0604-8
Ferone, D ; Profka, E ; Gasco, V ; Ambrosio, M R ; Colao, A ; Di Somma, C ; Puxeddu, E ; Arnaldi, G ; Pagano, C ; Zecchi, E ; Pietropoli, A ; Beck-Peccoz, P. / Long-term safety and efficacy of Omnitropein adults with growth hormone deficiency : Italian interim analysis of the PATRO Adults study. In: Journal of Endocrinological Investigation. 2017 ; Vol. 40, No. 6. pp. 669-678.
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T1 - Long-term safety and efficacy of Omnitropein adults with growth hormone deficiency

T2 - Italian interim analysis of the PATRO Adults study

AU - Ferone, D

AU - Profka, E

AU - Gasco, V

AU - Ambrosio, M R

AU - Colao, A

AU - Di Somma, C

AU - Puxeddu, E

AU - Arnaldi, G

AU - Pagano, C

AU - Zecchi, E

AU - Pietropoli, A

AU - Beck-Peccoz, P

PY - 2017/6

Y1 - 2017/6

N2 - PURPOSE: To report the long-term effectiveness and safety of the recombinant human growth hormone Omnitrope®, a somatropin biosimilar to Genotropin®, in Italian patients with growth hormone deficiency (GHD) enrolled in the PATRO Adults study.METHODS: The PATRO Adults study is an ongoing observational, longitudinal, non-interventional global post-marketing surveillance study, conducted in several European countries. The primary endpoint is long-term safety; secondary endpoints include the effectiveness of Omnitrope®, which was assessed using serum insulin-like growth factor-1 levels, body composition, bone mineral density and lipid levels. Here we report the data from the Italian patients enrolled in the study.RESULTS: Sixty-seven patients (mean age 50.4 years, 61.2% male) have been enrolled and have received a mean 45.4 ± 24.3 months of Omnitrope®. A total of 55.2% of patients were reported to have experienced adverse events (AEs), including arthralgia, myalgia, abdominal distension and hypoaesthesia, and 4.5% had adverse drug reactions. Fourteen serious AEs have been recorded; none of these are considered related to the study drug. The effectiveness of Omnitrope®was similar to other available somatropin preparations.CONCLUSIONS: This study confirms the effectiveness and safety of Omnitrope®in adult patients with GHD in Italy. However, due to the limited size of the study population, these results need to be further confirmed by the global PATRO Adults study.

AB - PURPOSE: To report the long-term effectiveness and safety of the recombinant human growth hormone Omnitrope®, a somatropin biosimilar to Genotropin®, in Italian patients with growth hormone deficiency (GHD) enrolled in the PATRO Adults study.METHODS: The PATRO Adults study is an ongoing observational, longitudinal, non-interventional global post-marketing surveillance study, conducted in several European countries. The primary endpoint is long-term safety; secondary endpoints include the effectiveness of Omnitrope®, which was assessed using serum insulin-like growth factor-1 levels, body composition, bone mineral density and lipid levels. Here we report the data from the Italian patients enrolled in the study.RESULTS: Sixty-seven patients (mean age 50.4 years, 61.2% male) have been enrolled and have received a mean 45.4 ± 24.3 months of Omnitrope®. A total of 55.2% of patients were reported to have experienced adverse events (AEs), including arthralgia, myalgia, abdominal distension and hypoaesthesia, and 4.5% had adverse drug reactions. Fourteen serious AEs have been recorded; none of these are considered related to the study drug. The effectiveness of Omnitrope®was similar to other available somatropin preparations.CONCLUSIONS: This study confirms the effectiveness and safety of Omnitrope®in adult patients with GHD in Italy. However, due to the limited size of the study population, these results need to be further confirmed by the global PATRO Adults study.

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DO - 10.1007/s40618-016-0604-8

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SP - 669

EP - 678

JO - Journal of Endocrinological Investigation

JF - Journal of Endocrinological Investigation

SN - 0391-4097

IS - 6

ER -