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

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice Pub Date : 2025-06-01 DOI:10.1016/j.eprac.2025.03.005

Mojca Jensterle MD, PhD , Rok Herman MD , Ana Klinc MD , Katja Goričar PhD , Matej Rakusa MD, PhD , Andrej Janež MD, PhD

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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

Twenty-nine adult patients with GHD, pretreated 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, insulin-like growth factor-1 (IGF-1) standard deviation score, 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 Treatment Satisfaction Questionnaire for Medication-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 = .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 = .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. Nonsignificant 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.

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somapacitan治疗疲劳成人生长激素缺乏症患者的疗效：一项24周的随机主动对照试验。

目的：在一项为期24周的随机、主动对照研究中，我们评估了somapacitan对生长激素缺乏症（GHD）患者的疗效，这些患者因每日注射生长激素（GH）而出现疲劳。方法：29名成年GHD患者，每日GH治疗≥5年，报告治疗相关疲劳，随机分配到somapacitan或每日GH。结果测量从基线到第24周，通过药物治疗满意度问卷（TSQM-9）、IGF-1 SDS、葡萄糖和脂质参数、体成分、骨矿物质密度（BMD）、颈动脉内膜中膜厚度和反应性充血指数评估治疗满意度的变化。结果：TSQM-9评分变化差异显著，有利于somapacitan(估计差异，somapacitan-daily GH [95% CI]:23.2 [7.9；38.4]点，P=0.004)。从基线到研究结束的IGF-1水平、葡萄糖和脂质谱、内脏脂肪组织、脂肪量（%）、瘦体重和血管参数的估计变化在治疗组之间没有差异。腰椎骨密度差异有统计学意义（估计差异，somapacitan-daily GH [95% CI]-0.036 (-0.064, -0.009) gr/cm2， P=0.011）。结论：在因长期每日GH注射而感到疲劳的AGHD患者中，据报道somapacitan比每日GH更方便。它在维持IGF-1水平和身体成分、葡萄糖、脂质和血管参数方面有效，与每日生长激素相当。somapacitan对骨密度的非显著降低可能反映了骨代谢单位的有利增加，正如先前在naïve GHD患者中观察到的那样，在GH治疗的最初6个月期间。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Endocrine Practice ENDOCRINOLOGY & METABOLISM-

CiteScore

7.60

自引率

2.40%

发文量

546

审稿时长

41 days

期刊介绍： Endocrine Practice (ISSN: 1530-891X), a peer-reviewed journal published twelve times a year, is the official journal of the American Association of Clinical Endocrinologists (AACE). The primary mission of Endocrine Practice is to enhance the health care of patients with endocrine diseases through continuing education of practicing endocrinologists.