PMON60 Growth Hormone (GH) Replacement Therapy (GHRT) in Patients with Adult GH Deficiency (AGHD) Aged ≥60 Years: Data from NordiNet® IOS and the ANSWER Program

Abstract There are limited data on the effectiveness and safety of GHRT in older patients with AGHD. We compared real-world GHRT outcomes in older (aged ≥60 years) versus middle-aged (35–<60 years) adults. NordiNet® IOS (NCT00960128) and ANSWER (NCT01009905) were non-interventional studies investigating long-term effectiveness and safety of GHRT with Norditropin® (somatropin, Novo Nordisk). 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 ARs (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. Of the 759 patients in the EAS, 545 were middle-aged and 214 older adults, mean (standard deviation) age 48.5 (7.0) and 67.2 (4.9) years, with 45.9% and 39.3% females, respectively. At baseline, GH dose was 0.24 (0.16) and 0.20 (0.10) mg/day, insulin-like growth factor-I standard deviation score (IGF-I SDS) was -0.94 (1.40) and -0.82 (1.36) and BMI was 29.29 (6.09) and 28.95 (4.58) kg/m2, respectively. Mean follow-up was 5.4 (4.3) and 5.3 (3.9) years, respectively. Of the 2348 patients in the FAS, 1696 were middle-aged and 652 older adults, aged 48.4 (7.1) and 67.1 (5.1) years, of which 52.4% and 43.3% were female, respectively. Baseline GH dose was 0.32 (0.24) and 0.26 (0.18) mg/day, IGF-I SDS was -0.58 (1.53) and -0.27 (1.54) and BMI was 30.50 (7.26) and 29.42 (5.39) kg/m2, respectively. Mean follow-up was 5.2 (4.5) and 4.7 (3.9) years, respectively. Mean GH exposure was greater in women than men, and in middle-aged than older women (FAS); it increased slightly over time in all groups. Baseline IGF-I SDS was slightly higher in older versus middle-aged women, but not men (EAS). Mean IGF-I SDS increased from below 0 to values ≤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 older and middle-aged adults 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 the older group (16.64 vs 9.04, IRR 1.840 [1.291;2.622]). Similarly, the IRRs of patients ≥75 (n=59) years versus the middle-aged group were only significant for SAEs (23.09 vs 9.04; IRR 2.553 [1.113;5.855]). 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. Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m.