Five-Year Estimated Glomerular Filtration Rate in Adults with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study

Abstract

Introduction Chronic hypoparathyroidism is associated with higher risk of developing chronic kidney disease compared with the general population. This study evaluated changes in estimated glomerular filtration rate (eGFR) over a 5-year period in adult patients with chronic hypoparathyroidism treated with recombinant parathyroid hormone (1-84), rhPTH(1-84), compared with a historical control cohort of patients who did not receive rhPTH(1-84). Methods This retrospective cohort study included patients with chronic hypoparathyroidism treated with rhPTH(1-84) in the REPLACE (NCT00732615), RELAY (NCT01268098), RACE (NCT01297309), and HEXT (NCT01199614 and continuation study NCT02910466) clinical trials. A historical control cohort who did not receive parathyroid hormone but who had enrollment criteria similar to those for the clinical trials was selected from the IBM® Explorys electronic medical record database (January 2007–August 2019). Outcomes of interest were the annual rate of change in eGFR from baseline (i.e., eGFR slope) and the predicted eGFR change from baseline at years 1 through 5. Results The study comprised 72 adult patients with chronic hypoparathyroidism treated with rhPTH(1-84) and 176 control patients who did not receive rhPTH(1-84). Over 5 years, eGFR remained stable in the rhPTH(1-84) cohort, whereas eGFR declined at a rate of 1.67 mL/min/1.73 m 2 per year in the control cohort ( P < 0.001 for eGFR slope in the control cohort). At 5 years, predicted eGFR in the rhPTH(1-84) cohort increased from baseline by 1.21 mL/min/1.73 m 2 , whereas eGFR in the control cohort declined by 10.36 mL/min/1.73 m 2 , after adjusting for baseline variables. The difference in eGFR slopes between the cohorts over 5 years was 1.37 mL/min/1.73 m 2 per year (95% CI 0.62–2.13; P < 0.001). Conclusion Long-term treatment with rhPTH(1-84) was associated with stable eGFR compared with eGFR decline in the controls not treated with rhPTH(1-84). Preservation of renal function conferred by rhPTH(1-84) may benefit patients with chronic hypoparathyroidism by reducing risk of long-term renal complications.

Palopegteriparatide Treatment Improves Renal Function in Adults with Chronic Hypoparathyroidism: 1-Year Results from the Phase 3 PaTHway Trial

“…Several retrospective cohort studies of adults with chronic hypoparathyroidism treated with PTH therapy as an adjunctive treatment to conventional therapy had preservation of eGFR over 5 years, in contrast to a decline in eGFR in historical control cohorts [13][14][15]. A retrospective cohort study by Rejnmark et al showed that participants with chronic hypoparathyroidism from randomized, double-blind, placebo-controlled trials and open-label studies treated with recombinant human (rh) PTH (1-84) had a 53% lower risk of developing CKD (HR 0.5, 95% CI 0.3-0.9) and 65% lower risk for sustained eGFR decline C 30% from baseline (HR 0.4, 95% CI 0.1-0.9) compared with a historical control cohort of adults with chronic hypoparathyroidism selected from an electronic medical record database who had a prescription for active vitamin D but no use of rhPTH (1-84) or teriparatide [15].…”

Is Adynamic Bone Always a Disease? Lessons from Patients with Chronic Kidney Disease

“…Teriparatide showed efficacy in reducing the risk of fracture and improving vertebral and femoral neck BMD [ 191 ]. A recent study concluded that treatment with recombinant parathyroid hormone (1–84) in patients with chronic hypoparathyroidism over 5 years was associated with stable GFR compared to another untreated cohort in whom GFR declined by 1.67 mL/min/1.73 m 2 per year [ 192 ]. Abaloparatide, a fragment of parathyroid hormone-related peptide, stimulates bone formation and is approved as osteo-anabolic therapy in postmenopausal women with osteoporosis [ 193 ].…”