Efficacy of somapacitan in treatment-fatigue adult patients with growth hormone deficiency previously treated with once-daily growth hormone injections: a 24-week randomized active-controlled trial.

Abstract

Objective: We evaluated the efficacy of somapacitan in a 24-week, randomized, active-controlled study in patients with growth hormone deficiency (GHD) who experienced fatigue from daily growth hormone (GH) injections.

Methods: 29 adult patients with GHD, pre-treated with daily GH for ≥ 5 years, who had reported treatment-related fatigue, were randomized to somapacitan or 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: The difference in change in TSQM-9 score for convenience was significant, in favor of somapacitan (estimated difference, somapacitan-daily GH [95% CI]:23.2 [7.9; 38.4] points, P=0.004). No differences between treatment arms in estimated changes from baseline to study-end were observed for IGF-1 levels, glucose and lipid profile, visceral adipose tissue, fat mass (%), lean body mass, and vascular parameters. There was significant difference in BMD of the lumbar spine (estimated difference, somapacitan-daily GH [95% CI]-0.036 (-0.064, -0.009) gr/cm², P=0.011).

Conclusion: In AGHD patients who were fatigued from the long-term daily GH injections, somapacitan was reported to be more convenient than daily GH. It was effective in maintaining IGF-1 levels and body composition, glucose, lipids, and vascular parameters, comparable to daily GH. Non-significant decrease in BMD with somapacitan could reflect a favorable increase in bone metabolic units, as previously observed in naïve patients with GHD during the initial 6-month period of GH therapy.