Poster Presentation ESA-SRB-APEG-NZSE 2022

Growth hormone (GH) replacement therapy (GHRT) in patients with adult GH deficiency (AGHD) aged ≥60 years: data from NordiNet® IOS and the ANSWER Program (#305)

Matthias W Weber 1 , Murray B Gordon 2 , Charlotte Höybye 3 4 , Anne H Olsen 5 , Nicky Kelepouris 6 , Navid Nedjatian 7 , Beverly M K Biller 8 , Ana Svensson 9
  1. Unit of Endocrinology, Medical Department, University Hospital, Universitätsmedizin Mainz, der Johannes Gutenberg-Universität, Mainz, Germany
  2. Allegheny Neuroendocrinology Center, Division of Endocrinology, Allegheny General Hospital, Pittsburgh, Pennsylvania, USA
  3. Department of Endocrinology, Karolinska University Hospital, Stockholm, Sweden
  4. Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden
  5. Epidemiology, Novo Nordisk A/S, Søborg, Denmark
  6. US Medical Affairs – Rare Endocrine Disorders, Novo Nordisk Inc., Plainsboro, New Jersey, USA
  7. Global Medical Affairs – Rare Endocrine Disorders, Novo Nordisk Health Care AG, Zurich, Switzerland
  8. Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts, USA
  9. Novo Nordisk Oceania, North Sydney, NSW, Australia

Aims: Data on effectiveness and safety of GHRT in older patients with AGHD are limited. We compared real-world GHRT outcomes in older (≥60 years) versus middle-aged (35–<60 years) adults.

Methods: NordiNet® IOS (NCT00960128) and ANSWER (NCT01009905) were non-interventional studies investigating long-term effectiveness and safety of GHRT with Norditropin®. Safety was assessed in the full analysis set (FAS) from both studies (non-GH-naïve patients included). The effectiveness analysis set (EAS) was from NordiNet® IOS only (GH-naïve patients; ANSWER EAS included patients previously treated for ≤6 months). Serious adverse reactions (SARs) and non-serious adverse reactions (NSARs) with a suspected causal relationship to GHRT, and serious adverse events (SAEs) not considered related to GHRT, are presented as incidence rates per 1000 patient-years and as incidence rate ratios (IRRs) for older versus middle-aged adults.

Results: Baseline characteristics are shown (table). Mean GH exposure was greater in women than men, and in middle-aged than older women (FAS), increasing slightly over time in all groups. Baseline IGF-I SD score (SDS) was slightly higher in older women, but not men (EAS). Mean IGF-I SDS increased from <0 to ≤1.24 with GHRT. Mean changes in BMI (EAS) and HbA1c (EAS and FAS) were small and similar between age groups in both sexes.

No statistically significant differences were observed between age groups regarding incidence rates for NSARs (5.66 vs 5.38; IRR[mean, 95%CI] 1.051[0.604;1.831]) and SARs (1.00 vs 2.52; IRR 0.396[0.119;1.324]). As expected, SAE incidence rate (considered unrelated to GHRT) was higher in older patients (16.64 vs 9.04, IRR 1.840[1.291;2.622]). Similarly, IRRs of patients ≥75 years (n=59) versus middle-aged patients were only significant for SAEs (23.09 vs 9.04; IRR 2.553[1.113;5.855]).

Conclusion: These data suggest similar clinical outcomes with GHRT in patients with AGHD aged ≥60 compared with 35–<60 years without additional risk of adverse drug reactions in older patients.

62fe048fec986-Table.JPG