Clinical trial data have demonstrated the efficacy of etelcalcetide for reducing parathyroid hormone (PTH) levels in hemodialysis (HD) patients. We provide a real-world summary of etelcalcetide utilization, dosing, effectiveness, and discontinuation since its US introduction in April 2017.
New-user design within prospective cohort.
2596 new users of etelcalcetide from April 2017 through August 2019 in a national sample of adult, chronic HD patients in the US Dialysis Outcomes and Practice Patterns Study (DOPPS).
Baseline PTH, prior cinacalcet use, initial etelcalcetide dose.
Trajectories of etelcalcetide dose, use of mineral bone disorder (MBD) medications, and levels of PTH, serum calcium, and phosphorus in the 12 months following etelcalcetide initiation.
Cumulative incidence methods for etelcalcetide discontinuation and linear generalized estimating equations for trajectory analyses.
By August 2019 etelcalcetide prescriptions increased to 6% of HD patients from their first use in April 2017. Starting etelcalcetide dose was 15 mg/week in 70% of patients and 7.5 mg/week in 27% of patients; 49% of new users were prescribed cinacalcet in the prior 3 months. Etelcalcetide discontinuation was 9%, 17%, and 27% by 3, 6, and 12 months post-initiation. One year after etelcalcetide initiation, mean PTH levels declined by 40%, from 948 to 566 pg/mL, and the proportion of patients with PTH within target (150-599 pg/mL) increased from 33% to 64% overall, from 0% to 60% among patients with baseline PTH ≥600 pg/mL, and from 30% to 63% among patients with prior cinacalcet use. The proportion of patients with serum phosphorus >5.5 mg/dL decreased from 55% to 45%, while the prevalence of albumin-corrected serum calcium <7.5 mg/dL remained at 1%-2%. Use of active vitamin D (from 77% to 87%) and Ca-based phosphate binders (from 41% to 50%) increased in the 12 months following etelcalcetide initiation.
Data unavailable for provider dosing protocols, dose holds, or reasons for discontinuation.
In the 12 months following etelcalcetide initiation, patients had large and sustained reductions in PTH levels. These results support the utility of etelcalcetide as an effective therapy to achieve the KDIGO recommended guidelines for CKD-MBD markers in HD patients.

Copyright © 2021. Published by Elsevier Inc.