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Abstract: FR-PO135

Etelcalcetide Utilization and CKD-MBD Marker Responses in US Hemodialysis Patients

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Fuller, Douglas S., Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Lin, Tzu-Chieh, Amgen, Thousand Oaks, California, United States
  • Bhatt, Nisha, Amgen, Thousand Oaks, California, United States
  • Robinson, Bruce M., Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Pisoni, Ronald L., Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
Background

Etelcalcetide is a new intravenous calcimimetic approved in February 2017 for treating secondary hyperparathyroidism in US adult hemodialysis (HD) patients. Real-world etelcalcetide utilization practices are not well understood.

Methods

Monthly cross-sectional data from a national sample of 6041-9113 HD patients/month treated at 113-157 HD units/month in the US Dialysis Outcomes and Practice Patterns Study (February 2017-February 2019) were used to describe: (1) etelcalcetide use (% of patients prescribed ≥1 dose each month) and dose at etelcalcetide initiation, by dialysis organization (DO) size (LDO sample, 10+ units; non-LDO and hospital-based sample, <10 units), and (2) trends in serum parathyroid hormone (PTH), total calcium (Ca), and phosphorus (PO4) levels up to 12 months after etelcalcetide initiation.

Results

In February 2019, 6.1% of US HD patients were prescribed etelcalcetide, representing 21% of all US calcimimetic use. Etelcalcetide use was markedly higher in non-LDO facilities (25-26% of patients/month) than LDO facilities (2-3%). Mean initial etelcalcetide dose was 13.1 mg/wk (median: 11.5; IQR: 7.2, 13.4). At drug initiation, serum PTH was higher in LDO (median: 976 pg/ml, IQR: 596, 1709; >600: 75%) than non-LDO (median: 735 pg/ml; IQR: 448, 983; >600: 61%) facilities, mean serum total Ca was 9.0 mg/dl (median: 9.0; IQR: 8.5, 9.4), and mean serum PO4 was 5.7 mg/dl (median:5.4; IQR: 4.4, 6.6). Among patients remaining on treatment: (1) mean and median serum PTH decreased 32% and 46% by month 6, respectively; (2) mean total Ca decreased 0.35 mg/dl by month 2, and hypocalcemia (<7.5 mg/dl) was uncommon (4.8%; range by month: 2.1-7.5%); and (3) mean PO4 levels were relatively unchanged (range by month: 5.5-5.9 mg/dl).

Conclusion

Rapid uptake of etelcalcetide occurred in the US through February 2019, with substantial differences by DO size. Serum PTH steadily declined while treated with etelcalcetide, while calcium levels remained in the recommended range. Continued monitoring of etelcalcetide utilization will offer insights regarding titration patterns and laboratory target achievement.

Funding

  • NIDDK Support – Global support for the ongoing DOPPS Programs is provided without restriction on publications by a variety of funders. For details, see https://www.dopps.org/AboutUs/Support.aspx.