Safety and Effectiveness of a Biosimilar Recombinant Growth Hormone in Adults with Growth Hormone Deficiency: Analysis of Final Data from PATRO Adults, an International Post-Marketing Surveillance Study.

PURPOSE

Long-term studies are needed to investigate the safety of recombinant human growth hormone (rhGH) for the treatment of growth hormone deficiency (GHD) in routine practice. The objective of this study was to evaluate the safety and effectiveness of biosimilar rhGH (somatropin; Omnitrope) in adults with GHD.

METHODS

PAtients TReated with Omnitrope (PATRO) Adults was a post-marketing surveillance study conducted across Europe. The primary objective was the safety of biosimilar rhGH in adults, particularly the occurrence of glucose intolerance or diabetes mellitus and malignancies. All adverse events (AEs) were recorded throughout treatment. Treatment effectiveness was a secondary objective.

RESULTS

By December 2021, 1527 patients (50.3% male) were enrolled from 84 centers in 10 European countries. Most patients had adult-onset GHD (n = 1243; 81.4%) and 771 (50.5%) were rhGH-naïve at study entry. Median (interquartile range) treatment duration was 4.4 (1.90-7.30) years. Overall, 1181 patients (77.3%) reported 6667 AEs. Treatment-related AEs were reported in 143 patients (9.4%; 216 AEs); arthralgia was most common (n = 24). There were 49 confirmed diabetes mellitus events; 44 in newly diagnosed patients. Overall, 84 malignancies were reported. There were 46 treatment-related serious AEs in 39 patients (2.6%). The most frequently reported treatment-related serious AE was "metabolism and nutrition disorders" (n = 12). In rhGH-naïve patients, an increase in mean insulin-like growth factor-1 (IGF-1) standard deviation score (SDS) was observed from -2.03 at baseline to +0.28 at 5 years. An increase in IGF-1 SDS was also observed in previously treated patients from -0.71 to +0.35. Body mass index remained stable while blood lipid levels improved from baseline to 5 years.

CONCLUSION

Final data from PATRO Adults confirm that biosimilar rhGH (Omnitrope) is not associated with any unexpected safety signals, with no evidence of increased diabetogenic or carcinogenic risk, and is effective in real-world clinical practice.