Endocrine Abstracts

JOINT486

Objective: An important barrier to obtain treatment goals in adult growth hormone deficiency (AGHD) is poor adherence due to the burden of long-term treatment with once daily growth hormone (GH) injections. We aimed to evaluated the efficacy of long acting GH somapacitan in a 24-week, randomized, active-controlled study in treatment-fatigue patients with AGHD, previously treated with once daily GH.

Methods: 30 male or female patients with AGHD, previously treated with once-daily GH for ≥ 5 years, reporting fatigue from daily GH injections, were randomized to somapacitan or once-daily GH. Outcome measures were changes in treatment satisfaction assessed by Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9), IGF-1 SDS, glucose and lipid parameters, body composition, bone mineral density (BMD), carotid intima media thickness and reactive hyperaemia index, from baseline to week 24.

Results: At baseline, 38% of patients was sub-optimally treated with daily GH with median IGF-1 SDS outside the range of 0-2 SDS for at least 2 years prior the randomisation. At week 24, median IGF-I SDS was outside the range of 0-2 SDS in 5 patients (35, 7%) in daily GH group and in 1 patient (6. 6%) in somapacitan group. 6 patients receiving daily GH reported missing >5 doses of GH each month, while in the somapacitan group only 1 dose was missed in 1 patient in 24 weeks. TSQM-9 score for convenience increased significantly more with somapacitan vs daily GH (estimated difference, somapacitan-daily GH [95% CI]:23. 2 [7. 9; 38. 4] points, P = 0. 0004). No significant differences were observed between groups for changes from baseline to week 24 in median values of IGF-1, IGF-1 SDS, glucose homeostasis, lipid profile, visceral adipose tissue, fat mass (%), lean body mass and vascular parameters. There was significant difference between the groups in BMD of lumbar spine (estimated difference, somapacitan-daily GH [95% CI]-0. 036 (-0. 064, -0. 009) gr/cm2, P = 0. 011).

Conclusion: In the treatment fatigue patients with AGHD, somapacitan was reported to be more convenient than daily GH with better self-reported adherence. The changes in body composition, glucose, lipid and vascular parameters were similar in both groups. A small decrease in BMD when switching to somapacitan may reflect an initial favourable increase in the number of bone metabolic units. A similar effect on BMD was previously observed in treatment naïve patients with AGHD during the first 6 months after initiation of GH treatment, followed by an increase in BMD. Further studies on long-term efficacy and safety of somapacitan in AGHD are needed.