The intravenous calcimimetic etelcalcetide effectively reduces parathyroid hormone (PTH) levels in patients on hemodialysis who have secondary hyperparathyroidism (SHPT), according to real-world data.
In a sample from the US Dialysis Outcomes and Practice Patterns Study (DOPPS), 2596 patients receiving maintenance hemodialysis (HD) initiated etelcalcetide since the medication was approved in April 2017. The starting dose was 15 mg/week in 70% of patients and 7.5 mg/week in 27% of patients.
Over 12 months of etelcalcetide treatment, the proportion of patients with target-range PTH (150-599 pg/mL) increased from 33% to 64% overall, from 0% to 60% among those with baseline PTH of 600 pg/mL or higher, and from 30% to 63% among those with prior cinacalcet use, Angelo Karaboyas, PhD, of Arbor Research Collaborative for Health in Ann Arbor, Michigan, and colleagues reported in the American Journal of Kidney Diseases. Mean PTH levels decreased by 40% over 12 months, from 948 to 566 pg/mL.
The incidence of hyperphosphatemia (serum phosphorus level above 5.5 mg/dL) declined from 55% to 45% among patients with baseline PTH of 600 pg/mL or more, the investigators reported. Total alkaline phosphatase levels decreased from 131 to 107 U/L.
Hypocalcemia is a concern with etelcalcetide treatment. The proportion of patients with moderately low serum calcium (7.5 to 8.3 mg/dL) increased from 8% to 27% within 3 months of drug initiation, “supporting the need to monitor serum calcium levels,” according to the investigators. Only 1% to 2% of patients experienced a serum calcium level less than 7.5 mg/dL. In response to calcium concerns, active vitamin D use increased from 77% to 87%, and calcium-based phosphate binder use increased from 41% to 50%.
Etelcalcetide uptake increased to 6% of all patients by August 2019, the study authors noted. As many as 20% of patients received the intravenous treatment in small/independent dialysis facilities, but only 4% in large and midsize facilities, where the drug likely was reserved for those with PTH levels exceeding 1000 pg/mL. Black patients and those with longer dialysis vintage were more likely to receive the intravenous calcimimetic. Etelcalcetide was discontinued in 9%, 17%, and 27% of patients by 3, 6, and 12 months, respectively.
Clinical trial data have demonstrated the efficacy of etelcalcetide.
“Intravenously administered etelcalcetide is an effective therapy for PTH reduction, and has the potential to improve adherence and decrease pill burden for patients receiving in-center hemodialysis,” Dr Karaboyas’ team concluded.
Disclosure: This research was supported by Amgen. Please see the original reference for a full list of disclosures.
Karaboyas A, Muenz D, Fuller DS, et al. Etelcalcetide utilization, dosing titration, and chronic kidney disease-mineral and bone disease (CKD-MBD) marker responses in US hemodialysis patients. Am J Kidney Dis. Published online July 14, 2021. doi:10.1053/j.ajkd.2021.05.020