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Romer T, Zabransky M, Walczak M, et al. Effect of switching recombinant human growth hormone: Comparative analysis of phase 3 clinical data. Biol Ther. 2011;1:5doi: 10.1007/s13554-011-0004-8.
Romer, T., Zabransky, M., Walczak, M., Szalecki, M., & Balser, S. (2011). Effect of switching recombinant human growth hormone: Comparative analysis of phase 3 clinical data. Biologics in therapy, 15. https://doi.org/10.1007/s13554-011-0004-8
Romer, Tomasz, et al. "Effect of switching recombinant human growth hormone: Comparative analysis of phase 3 clinical data." Biologics in therapy vol. 1 (2011): 5. doi: https://doi.org/10.1007/s13554-011-0004-8
Romer T, Zabransky M, Walczak M, Szalecki M, Balser S. Effect of switching recombinant human growth hormone: Comparative analysis of phase 3 clinical data. Biol Ther. 2011 Dec 16;1:5. doi: 10.1007/s13554-011-0004-8. eCollection 2011. PMID: 24392295; PMCID: PMC3873068.
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Biol Ther. 2011 Dec 16;1:5. doi: 10.1007/s13554-011-0004-8. eCollection 2011.

Effect of switching recombinant human growth hormone: Comparative analysis of phase 3 clinical data.

Biologics in therapy

Tomasz Romer, Markus Zabransky, Mieczyslaw Walczak, Mieczyslaw Szalecki, Sigrid Balser

Affiliations

  1. Former Head of the Department of Endocrinology, Children's Health Research Institute, Warsaw, Poland.
  2. CDMA, Endocrinology, Sandoz International BU Biopharmaceuticals, Holzkirchen, Germany.
  3. Department of Pediatrics and Endocrinology, Pomeranian Medical University, Szczecin, Poland.
  4. Department of Endocrinology, Children's Health Research Institute, Warsaw, Poland ; Department of Health Sciences, University of Jan Kochanowski, Kielce, Poland.

PMID: 24392295 PMCID: PMC3873068 DOI: 10.1007/s13554-011-0004-8

Abstract

INTRODUCTION: Recombinant human growth hormone (rhGH) is effective and safe when used to treat growth hormone deficiency (GHD) in children. However, it has been suggested that switching between different types of rhGH can have a detrimental effect on patients.

METHODS: The current analysis assessed the efficacy and safety of rhGH in children who received continuous Omnitrope® (Sandoz GmbH, Kundl, Austria) therapy either with lyophilized powder for solution or ready-to-use solution, with children who received 9 months of treatment with Genotropin® (Pfizer Limited, Sandwich, UK) followed by Omnitrope solution thereafter. Changes to height, height SD score (SDS), height velocity SDS, insulin-like growth factor (IGF-1) levels, and IGF binding protein (IGFBP-3) levels were assessed using data from three trials.

RESULTS: Baseline demographics of the three study groups were similar. Over an 18-month period there were no observable differences between the three groups with respect to height, height SDS, height velocity SDS, IGF-1 levels, and IGFBP-3 levels. This result was corroborated by the model data, whereby most data points for Omnitrope-treated children fell within the defined limits of the prediction model based on Genotropin data. Few adverse drug reactions (ADRs) occurred.

CONCLUSIONS: Switching from Genotropin to Omnitrope solution has no impact on efficacy or safety in children with GHD, and the various rhGH preparations are well tolerated.

Keywords: Omnitrope; children; efficacy; genotropin; growth hormone deficiency (GHD); immunogenicity; recombinant human growth hormone (rhGH); safety; switching

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