Siggelkow Heide, Peschke Kim A, Tsourdi Elena, Hofbauer Lorenz C, Berr Christina M, Hahner Stefanie, Lottspeich Christian, Schmidmaier Ralf, Blaschke Martina
Department of Trauma, Orthopedics and Reconstructive Surgery, University Medical Center Göttingen, Göttingen 37075, Germany.
MVZ endokrinologikum Göttingen, Center for Endocrinology, Osteology, Rheumatology, Nulear Medicine and Human Genetics, Göttingen 37075, Germany.
J Endocr Soc. 2025 Jun 30;9(9):bvaf113. doi: 10.1210/jendso/bvaf113. eCollection 2025 Sep.
Replacement therapy with recombinant human PTH (rhPTH1-84) represents a causal treatment for patients with chronic hypoparathyroidism (HypoPT). Recently, palopegteriparatide (TransCon PTH), a novel long-acting drug with slow release of PTH1-34, was approved by the European Medicines Agency and Food and Drug Administration for treatment of HypoPT. To date, no data exist on the treatment switch from rhPTH1-84 to TransCon PTH.
We retrospectively analyzed clinical data from 40 patients with chronic HypoPT during the switch from rhPTH1-84 to TransCon PTH. Independent of the last prior rhPTH1-84 dose, all patients were started on 18 µg of TransCon PTH as recommended by the manufacturer. TransCon PTH dose adjustments, changes in additional medication, and adverse events were documented during the treatment switch.
Within the first month after the treatment switch, 80% (n = 32) of patients needed individual adjustment of their TransCon PTH dose to achieve normocalcemia. Dose reduction (to 9-15 µg) was necessary in 38% (n = 15) and an increase (to 21-27 µg) in 43% (n = 17) of patients. Adjustments occurred predominantly (in 62% cases) according to serum calcium levels, partly dependent on symptoms. The prior applied rhPTH1-84 dose correlated significantly with the adjusted TransCon PTH dose (r = 0.4; = .01). The treatment change was associated with moderate or mild adverse events in 24/40 patients.
We hereby report the first clinical data on switching treatment from rhPTH1-84 to 18 µg TransCon PTH independent of the prior rhPTH1-84 dose. Our data support discrete adaptation of the starting dose depending on the prior rhPTH1-84 dosage.
重组人甲状旁腺激素(rhPTH1-84)替代疗法是慢性甲状旁腺功能减退症(HypoPT)患者的一种病因治疗方法。最近,帕洛佩特立帕肽(TransCon PTH),一种新型长效药物,可缓慢释放PTH1-34,已获得欧洲药品管理局和美国食品药品监督管理局批准用于治疗HypoPT。迄今为止,尚无关于从rhPTH1-84转换为TransCon PTH治疗的数据。
我们回顾性分析了40例慢性HypoPT患者从rhPTH1-84转换为TransCon PTH期间的临床数据。不考虑最后一次之前的rhPTH1-84剂量,所有患者均按照制造商的建议开始使用18μg的TransCon PTH。在治疗转换期间记录TransCon PTH剂量调整、额外药物的变化和不良事件。
在治疗转换后的第一个月内,80%(n = 32)的患者需要单独调整其TransCon PTH剂量以实现血钙正常。38%(n = 15)的患者需要减少剂量(至9-15μg),43%(n = 17)的患者需要增加剂量(至21-27μg)。调整主要(62%的病例)根据血清钙水平进行,部分取决于症状。先前应用的rhPTH1-84剂量与调整后的TransCon PTH剂量显著相关(r = 0.4;P = 0.01)。24/40例患者的治疗变化与中度或轻度不良事件相关。
我们在此报告了首例关于不考虑先前rhPTH1-84剂量从rhPTH1-84转换为18μg TransCon PTH治疗的临床数据。我们的数据支持根据先前的rhPTH1-84剂量对起始剂量进行个体化调整。