Patient outcomes in the GHMonitor: the effect of delivery device on compliance and growth

Paul Desrosiers1, Fanny O'Brien, Sandra Blethen

  • 1Department of Pediatric Endocrinology, Nemours Children's Clinic, Orlando, 32806, and Department of Pediatric Endocrinology, University of Florida, Gainesville, FL, USA. pdesrosiers@nemours.org

Insights

Growth hormone (GH) administration method did not impact patient outcomes over two years. However, the needle-free delivery system (NFDS) showed better compliance, potentially improving outcomes in non-compliant patients.

Area of Science:

  • Pediatric Endocrinology
  • Pharmacology
  • Biotechnology

Background:

  • Growth hormone (GH) therapy is crucial for pediatric growth disorders.
  • Administration methods, including needle-and-syringe and needle-free devices, may influence treatment adherence and efficacy.
  • Saizen GH (somatropin [rDNA origin] for injection) is a commonly used recombinant human growth hormone formulation.

Purpose of the Study:

  • To compare the efficacy of two different methods of growth hormone administration on patient outcomes.
  • To assess the impact of needle-and-syringe versus needle-free delivery system (NFDS) on growth response in children.
  • To evaluate patient compliance with growth hormone therapy based on the administration device used.

Main Methods:

  • Analysis of data from 631 North American children in the GHMonitor electronic database.
  • Comparison of growth rates, height SD scores, and height age changes over two years between children treated with needle-and-syringe (n=305) and NFDS (n=326).
  • Assessment of patient compliance, defined by the number of missed GH doses per month.

Main Results:

  • No significant differences in growth response were observed between the needle-and-syringe and NFDS groups over two years.
  • A higher proportion of patients using needle-and-syringe missed over half of their prescribed GH doses compared to NFDS users (13.4% vs. 6%, P=.002).
  • Poorly compliant patients in both groups exhibited significantly lower growth rates than those with better adherence.

Conclusions:

  • The method of GH administration (needle-and-syringe vs. NFDS) did not affect overall treatment outcomes in this cohort.
  • The needle-free delivery system (NFDS) was associated with significantly better patient compliance.
  • For patients with compliance challenges, utilizing an NFDS may lead to improved growth hormone therapy outcomes.

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