Long-term safety and efficacy of Omnitrope ® in adults with growth hormone deficiency: Italian interim analysis of the PATRO Adults study

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.

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