Long-term safety and efficacy of Omnitrope®in adults with growth hormone deficiency: Italian interim analysis of the PATRO Adults study.
OBJECTIVE
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.
Endocrinology Unit, Department of Internal Medicine and Medical Specialties (DiMI), Center of Excellence for Biomedical Research (CEBR), IRCCS AOU San Martino-IST, University of Genova, Viale Benedetto XV, 6, 16132, Genova, Italy. ferone@unige.it.
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Ferone
Endocrinology and Metabolic Diseases Unit, Department of Clinical Sciences and Community Health, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, University of Milano, Milan, Italy.
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Profka
Endocrinology, Diabetes and Metabolism, Department of Medical Science, Città della Salute e della Scienza di Torino, University of Torino, Turin, Italy.
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Gasco
Section of Endocrinology and Internal Medicine, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.
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Ambrosio
Department of Clinical Medicine and Surgery, University Federico II of Napoli, Naples, Italy.
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Colao
Institute of Diagnostic and Nuclear Research, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico SDN, Naples, Italy.
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Di Somma
Veterinary and Forensic Biotechnological Sciences Department of Medicine Section, Internal Medicine, Endocrine and Metabolic Sciences, University of Perugia, Perugia, Italy.
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Puxeddu
Clinica di Endocrinologia e Malattie del Metabolismo, Ospedali Riuniti di Ancona, Ancona, Italy.
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Arnaldi
Department of Medicine, Internal Medicine 3, University of Padova, Padua, Italy.
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Pagano
Sandoz S.p.A., Origgio, VA, Italy.
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Zecchi
Hexal AG, Holzkirchen, Germany.
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Pietropoli
Endocrinology and Diabetology Unit, Medical Sciences Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.
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Beck-Peccoz
D000328:Adult; D000368:Aged; D001827:Body Height / Q000187:drug effects*; D015519:Bone Density / Q000187:drug effects*; D005260:Female; D006130:Growth Disorders / Q000188:drug therapy*; D019382:Human Growth Hormone / Q000627:therapeutic use*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D012449:Safety
D019382:Human Growth Hormone
Growth hormone deficiency; Hypopituitarism; Insulin-like growth factor-1; Omnitrope®; Recombinant human growth hormone; Safety