Dateki Sumito, Sato Yukihito, Tsuboi Satoshi, Mori Jun
Department of Pediatrics, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8102, Japan.
Novo Nordisk Pharma Ltd., Tokyo 100-0005, Japan.
Endocr J. 2025 May 7;72(5):475-485. doi: 10.1507/endocrj.EJ24-0225. Epub 2025 Feb 20.
Limited real-world data are available on persistence to growth hormone replacement therapy (GHRT) in Japan. Therefore, we used the Japan Medical Data Center claims database to retrospectively investigate persistence with GHRT in patients with pediatric growth hormone deficiency (pGHD). We identified 1,020 patients with pGHD treated with GHRT. The mean age at initial diagnosis was 7.5 ± 3.8 years, and we found a bimodal pattern in age, with peaks at 3 and 12 to 13 years of age; the peaks were more pronounced in male patients. After excluding patients with early withdrawal, 1,016 patients were eligible for persistence analysis. The time to initial treatment discontinuation, i.e., the first prescription-free period of 182 days (6 months) or more, for 50% of the patients was 2,526 days, which was similar to that of treatment completion (2,626 days). Most patients persisted with GHRT until they completed treatment, but 24 out of 1,016 (2.4%) had a treatment discontinuation. The mean proportion of days covered was 89.8%. Being female (hazard ratio [95% CI]: 1.85 [1.36-2.51]) and older age at diagnosis (1.50 [1.41-1.60]) were associated with shorter time to discontinuation. This finding suggests that most patients persist with GHRT until puberty. In conclusion, although most Japanese patients with pGHD appear to persist well with GHRT, some complete GHRT before puberty. Additionally, there are patients diagnosed and starting treatment just before puberty. Therefore, continued efforts towards early referral and diagnosis are important.
在日本,关于生长激素替代疗法(GHRT)持续性的真实世界数据有限。因此,我们使用日本医疗数据中心的索赔数据库,对小儿生长激素缺乏症(pGHD)患者接受GHRT的持续性进行了回顾性研究。我们确定了1020例接受GHRT治疗的pGHD患者。初次诊断时的平均年龄为7.5±3.8岁,我们发现年龄呈双峰模式,在3岁以及12至13岁时出现峰值;男性患者的峰值更为明显。在排除早期停药的患者后,1016例患者符合持续性分析条件。50%的患者首次治疗中断的时间,即首次无处方期达182天(6个月)或更长时间,为2526天,这与治疗完成时间(2626天)相似。大多数患者持续接受GHRT直至完成治疗,但1016例中有24例(2.4%)出现治疗中断。所涵盖天数的平均比例为89.8%。女性(风险比[95%置信区间]:1.85[1.36 - 2.51])以及诊断时年龄较大(1.50[1.41 - 1.60])与较短的停药时间相关。这一发现表明,大多数患者持续接受GHRT直至青春期。总之,尽管大多数日本pGHD患者似乎能很好地坚持接受GHRT,但有些患者在青春期前就完成了GHRT治疗。此外,还有一些患者在青春期前刚被诊断并开始治疗。因此,持续努力实现早期转诊和诊断很重要。