ECE2024 Oral Communications Oral Communications 2: Calcium and Bone | Part I (6 abstracts)
Sustained improvement in renal function with palopegteriparatide in adults with chronic hypoparathyroidism: 2-year results from the phase 3 PaTHway trial
Peter Schwarz 1 , Lars Rejnmark 2 , Elvira Gosmanova 3 , Aliya Khan 4 , Noriko Makita 5 , Yasuo Imanishi 6 , Yasuhiro Takeuchi 7,8 , Stuart Sprague 9 , Dolores M. Shoback 10,11 , Lynn Kohlmeier 12 , Mishaela Rubin 13 , Andrea Palermo 14,15 , Claudia Gagnon 16,17 , Elena Tsourdi 18 , Carol Zhao 19 , Michael Makara 19 , Michael Ominsky 19 , Bryant Lai 19 , Jenny Ukena 19 , Christopher Sibley 19 & Aimee Shu 19
1Rigshospitalet, Copenhagen, Denmark; 2Aarhus University Hospital, Aarhus, Denmark; 3Albany Medical College, Albany, United States; 4McMaster University, Hamilton, Canada; 5University of Tokyo Graduate School of Medicine, Tokyo, Japan; 6Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan; 7Toranomon Hospital, Tokyo, Japan; 8Okinaka Memorial Institute for Medical Research, Tokyo, Japan; 9NorthShore University Health System-University of Chicago Pritzker School of Medicine, Chicago, United States; 10University of California, San Francisco, United States; 11VA Medical Center, San Francisco, United States; 12Endocrinology and Spokane Osteoporosis, Spokane, United States; 13Columbia University, New York, United States; 14Fondazione Policlinico Campus Bio-medico, Rome, Italy; 15Unit of Endocrinology and Diabetes, Campus Bio-medico University, Rome, Italy; 16CHU de Québec-Université Laval Research Centre, Québec, Canada; 17Department of Medicine, Université Laval, Quebec City, Québec, Canada; 18Technische Universität Dresden Medical Center, Dresden, Germany; 19Ascendis Pharma Inc, Palo Alto, United States
Hypoparathyroidism is an endocrine disease caused by insufficient levels of parathyroid hormone (PTH). Individuals with chronic hypoparathyroidism managed with conventional therapy (active vitamin D and calcium) are at increased risk for renal complications and declines in renal function. In clinical trials, palopegteriparatide treatment enabled independence from conventional therapy (no active vitamin D and ≤600 mg/day elemental calcium) and maintained serum biochemistries within normal ranges. This analysis examines the impact of palopegteriparatide treatment on renal function in adults with chronic hypoparathyroidism through week 104 of the PaTHway trial. PaTHway is a phase 3 trial with a randomized, double-blind, placebo-controlled 26-week period and ongoing 156-week open-label extension. Estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73 m2 was required for eligibility. In this post hoc analysis, changes in renal function were assessed using eGFR. Safety assessments included 24-hour urine calcium excretion and treatment-emergent adverse events (TEAEs). At week 104, 93% (76/82) of participants remained in the trial. Of those, 82% had normal albumin-adjusted serum calcium levels (2.07-2.64 mmol/l), 97% were independent from conventional therapy, and none required active vitamin D. Mean (SD) serum phosphate (1.1(0.2) mmol/l) and albumin-adjusted calcium × phosphate product (2.5(0.4) mmol2/l2) levels were also within normal ranges. At week 104, mean (SD) eGFR was 77.8 (14.8) ml/min/1.73 m2. Palopegteriparatide treatment resulted in a mean (SD) increase in eGFR of 8.9 (11.0) ml/min/1.73 m2 (P<.0001) from baseline to week 52, which was sustained through week 104 with a mean (SD) change from baseline of 9.0 (10.3) ml/min/1.73 m2 (P<.0001). By week 104, 61% and 44% of participants had an increase in eGFR of ≥5 ml/min/1.73 m2 and ≥10 ml/min/1.73 m2 respectively. Among participants with baseline eGFR<60 ml/min/1.73 m2 (n=23), palopegteriparatide treatment resulted in a mean (SD) increase in eGFR of 13.8 (10.0) ml/min/1.73 m2 from baseline to week 104, and 78% and 57% had an increase in eGFR of ≥5 ml/min/1.73 m2 and ≥10 ml/min/1.73m2 respectively. Palopegteriparatide treatment normalized mean 24-hour urine calcium within 26 weeks and maintained levels below 6.2 mmol/day through week 104 (4.0(2.3) mmol/day). No cases of nephrolithiasis were reported with palopegteriparatide treatment. Most TEAEs were mild or moderate; no new safety signals were reported. This post hoc analysis of the phase 3 PaTHway trial through week 104 demonstrates the sustained renal safety of palopegteriparatide and suggests that PTH replacement therapy with palopegteriparatide and independence from conventional therapy may not only preserve but improve renal function in adults with chronic hypoparathyroidism.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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