Safety and Effectiveness of Omnitrope (R), a Biosimilar Recombinant Human Growth Hormone: More Than 10 Years' Experience from the PATRO Children Study

Pfaeffle, Roland; Bidlingmaier, Martin; Kreitschmann-Andermahr, Ilonka; Land, Christof; Partsch, Carl Joachim; Schwab, Karl Otfried; Sommer, Heide; Backeljauw, Philippe; Kanumakala, Shankar; Loche, Sandro; Zouater, Hichem und Strasburger, Christian J. (2020): Safety and Effectiveness of Omnitrope (R), a Biosimilar Recombinant Human Growth Hormone: More Than 10 Years' Experience from the PATRO Children Study. In: Hormone Research in Paediatrics, Bd. 93, Nr. 3: S. 154-163

Abstract

Introduction:Omnitrope (R) was approved as a biosimilar recombinant human growth hormone (rhGH) in 2006.Objective:The purpose of this work was to evaluate the long-term safety and effectiveness of Omnitrope (R) in PATRO Children - an ongoing, international, longitudinal, non-interventional study in children who require rhGH treatment.Methods:The study population includes infants, children, and adolescents receiving Omnitrope (R). Adverse events (AEs) are monitored for safety and rhGH effectiveness is evaluated by calculation of the height standard deviation score (HSDS), height velocity (HV), and HVSDS using height measurements and country-specific references.Results:As of November 2017, 6,009 patients from 298 centers across 14 countries were enrolled in PATRO Children. Overall, 57.7% of patients had growth hormone deficiency (GHD), 25.8% were born small for gestational age (SGA), and 4.8% had Turner syndrome (TS). In total, 84.1% were rhGH treatment naive at study entry. The mean duration of Omnitrope (R) treatment in the study was 36.1 months (range 0-133.7). Overall, 10,360 AEs were reported in 2,750 patients (45.8%). Treatment-related AEs were reported in 396 patients (6.6%;550 events), and serious AEs (SAE) in 636 patients (10.6%;1,191 events);50 SAEs in 37 patients (0.6%) were considered treatment related. Following 5 years of therapy in patients who were rhGH treatment naive at study entry, improvement from baseline in mean HSDS was +1.85 in GHD, +1.76 in SGA, and +1.0 in TS patients. In total, 912 (17.9%) patients reached adult height (n= 577 GHD,n= 236 SGA,n= 62 TS).Conclusions:This analysis of PATRO Children indicates that biosimilar rhGH is well tolerated and effective in real-world clinical practice.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 1663-2818
• Sprache: Englisch