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The Real-World Effectiveness of Velphoro in Patients on Chronic Dialysis

Robert J. Kossmann, MD, FACP, FASN

By Linda Ficociello, DSc & Robert J. Kossmann, MD, FACP, FASN & Claudy Mullon, PhD

Published 06.22.2018

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(SO = sucroferric oxyhydroxide (Velphoro), Sev = sevelamer, CaAc = calcium acetate, LC = lanthanum carbonate)
FIGURE 1 | Percentage of patients with sP 5.5 mg per dL at baseline and during months 4-6

Real-world data analyses for PD patients (n = 258) also showed improvements in sP levels along with reductions in PB pill burden after switching to Velphoro (Figure 3).17The proportion of patients achieving sP 5.5 mg per dL increased by 72 percent from baseline to month 6 of Velphoro follow-up. Prescribed PB pills per day decreased by 57 percent from 10 at BL to 4.3 at Velphoro follow-up (p < 0.0001).

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* p < 0.05; ** p < 0.001; *** p < 0.0001
FIGURE 2 | Two-year follow-up on Velphoro: percentage of patients with sP 5.5 mg per dL stratified by phosphate binder at baseline

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** p < 0.001; *** p < 0.0001
FIGURE 3 | Peritoneal dialysis patients with sP < 5.5 mg per dL by month (reference for statistical comparisons is month –1)

An analysis of 103 patients on HHD prescribed Velphoro for six months showed improvement in sP (Figure 4).18 Patients achieving sP 5.5 mg per dL increased by 96 percent, from 24.3 percent at baseline to 47.6 percent during Velphoro treatment. The number  of PB pills per day was reduced from 8.9 to 4.3 pills per day.

Several sub-analyses were conducted to examine the effectiveness of Velphoro in specific HD patient populations. Among Hispanics/Latin Americans prescribed Velphoro, the percent of patients achieving sP < 5.5 mg per dL increased by 73 percent and the number of PB pills per day decreased by greater than 50 percent after six months.19 Black/African American patients prescribed Velphoro experienced a 58 percent increase in achieving sP < 5.5 mg per dL along with a greater than 50 percent reduction in number of PB pills per day.20 A subpopulation of patients with low serum albumin (< 3.5 g per dL) was analyzed to determine nutritional status and phosphorus control after  switching to Velphoro.21 Serum albumin levels increased, while serum phosphorus levels decreased. These finding are being further investigated, as both low serum albumin and high serum phosphorus are known predictors of increased mortality risk.22,23 Sub-analyses of iron indices showed that changes were consistent with the findings reported in the phase III trial, where increases from baseline were not clinically significant and increases were mainly observed in patients receiving IV iron.24,25,26

In summary, significant increases (between 70 and 135 percent) in the number of patients achieving sP 5.5 mg per dL were observed for HD, HHD, and PD patients switched from any of the major binders (sevelamer, calcium acetate, lanthanum, and ferric citrate) to Velphoro, supporting the potency of Velphoro as a PB with a low pill burden. By reducing the PB pill number by half or more, Velphoro helps reduce the total daily pill burden and may improve adherence to medications. Ongoing and future data analyses include combination PB therapies, improved adherence, and assessing potential cost savings associated with lowering serum phosphorus (e.g., reducing hospitalization risk).27

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FIGURE 4 | Percent of home hemodialysis patients achieving serum phosphorus < 5.5 mg per dL after switched to Velphoro as part of routine clinical care (SO = sucroferric oxyhydroxide  [Velphoro])

Meet Our Experts

Linda Ficociello, DSc
Director, Epidemiology, Fresenius Medical Care

In her seven years with Fresenius Medical Care Renal Therapies Group, Linda Ficociello has focused her research on evidence-based medicine and database studies on various topics, including bone and mineral metabolism and home dialysis therapies. She earned her bachelor’s degree at the University of New Hampshire, and her doctorate in epidemiology and master of science at Boston University School of Public Health. She completed her training as a post-doctoral fellow at Harvard Medical School.

Robert J. Kossmann, MD, FACP, FASN
Senior Vice President, Chief Medical Officer, Renal Therapies Group, Fresenius Medical Care

Robert “Rob” Kossmann practiced nephrology for two decades prior to joining FMCNA in 2014. The former president of the Renal Physicians Association and founding member of its Nephrology Coverage Advocacy Program, he served as nephrology advisor to the American Medical Association’s Relative Value Scale Update and founded the New Mexico Renal Disease Collaborative Group.

Claudy Mullon, PhD
Vice President, Medical Affairs & Clinical Research, Fresenius Medical Care

Claudy Mullon received his doctorate from Washington University in St. Louis and was a postdoctoral fellow at MIT where he remained a research affiliate for 10 years. He has co-authored more than 50 articles in peer-reviewed journals and is an inventor on 20 US patents. He is a current member of the American Society of Transplantation and an elected fellow of the American Institute for Medical and Biological Engineering.

References

The Real-World Effectiveness of Velphoro in Patients on Chronic Dialysis
by Linda Ficociello, DSc, Robert J. Kossmann, MD, FACP, FASN &
Claudy Mullon, PhD

  1. Joson CG, Henry SL, Kim S, et al. Patient-reported factors associated with poor phosphorus control in a maintenance hemodialysis population. J Ren Nutr 2016;26(3):141-48.
  2. Koiwa F, Yokoyama K, Fukagawa M, Terao A, Akizawa T. Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer hydrochloride in Japanese haemodialysis patients with hyperphosphataemia: a randomized, open-label, multicentre, 12-week phase III study. Nephrology (Carlton) 2017;22(4):293-300.
  3. Tonelli M, Pannu N, Manns B. Oral phosphate binders in patients with kidney failure. N Engl J Med 2010;362:1312-24.
  4. Fissell RB, Karaboyas A, Bieber BA, et al. Phosphate binder pill burden, patient-reported non-adherence, and mineral bone disorder markers: findings from the DOPPS. Hemodial Int 2016;20(1):38-49.
  5. Locatelli F, Del Vecchio L, Violo L, Pontoriero G. Phosphate binders for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis: a comparison of safety profiles. Expert Opin Drug Saf 2014;13(5):551-561.
  6. Block GA, Hulbert-Shearon TE, Levin NW, Port FK. Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients: a national study. Am J Kidney Dis 1998;31(4):607-617.
  7. National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis 2003;42(4 Suppl 3):S1-201.
  8. US DOPPS (Dialysis and Advanced CKD Outcomes and Practice Patterns Study Program) practice monitor: serum phosphorous (most recent). August 2017.    http://www.dopps.org/dpm/.
  9. Chiu YW, Teitelbaum I, Misra M, de Leon EM, Adzize T, Mehrotra R. Pill burden, adherence, hyperphosphatemia, and quality of life in maintenance dialysis patients. Clin J Am Soc Nephrol 2009;4(6):1089-96.
  10. Ibid.
  11. US DOPPS practice monitor. http://www.dopps.org/dpm/.
  12. Covic A, Rastogi A. Hyperphosphatemia in patients with ESRD: assessing the current evidence linking outcomes with treatment adherence. BMC Nephrol 2013;14:153.
  13. Fissell et al. Phosphate binder pill burden.
  14. Floege J, Covic AC, Ketteler M, et al. Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients. Nephrol Dial Transplant 2015;30(6):1037-46.
  15. Coyne DW, Ficociello LH, Parameswaran V, Anderson L, Vemula S, Ofsthun NJ, Mullon C, Maddux FW, Kossmann RJ, Sprague SM. Real-world effectiveness of sucroferric oxyhydroxide in patients on chronic hemodialysis: a retrospective analysis of pharmacy data. Clin Nephrol 2017;88(8):59-67.
  16. Coyne DW, Ficociello LH, Parameswaran V, Ofsthun NJ, Mullon C, Kossmann RJ, Sprague SM. Effectiveness of sucroferric oxyhydroxide in lowering serum phosphorus in 4,925 chronic hemodialysis patients. [Poster TH-PO1031] J Am Soc Nephrol 28: 2017.
  17. Kalantar-Zadeh K, Parameswaran V, Ficociello LH, Anderson L, Ofsthun NJ, Kwoh, C, Mullon C, Kossmann RJ, Coyne, DW. Real-world improvements in serum phosphorus levels and pill burden in peritoneal dialysis patients treated with sucroferric oxyhydroxide. Am J Nephrol 2018;47(3):153-161.
  18. Broumand V, Ficociello L, Li Y, Parameswaran V, Mullon C, Kossmann R. Serum phosphorus and phosphate binder pill per day in home hemodialysis patients prescribed sucroferric oxyhydroxide. Hemodialysis Abstracts from the 38th Annual Dialysis Conference March 3-6, 2018 Orlando, Florida. Hemodialysis International 2018;22(1):A1-A44.
  19. Henriquez M, Ficociello LH, Parameswaran V, Mullon C, Kossmann RJ. Phosphate binder pill burden and achievement of within-range serum phosphorus among Hispanic hemodialysis patients treated with sucroferric oxyhydroxide. Am J Kidney Dis 2017 April;69(4):A51. https://doi.org/10.1053/j.ajkd.2017.02.148.
  20. Ficociello LH, Ma L, Parameswaran V, Mullon C, Maddux FW, Kossmann RJ. Improved serum phosphorus control and decreased phosphate binder pill burden amongst African American hemodialysis patients taking sucroferric oxyhydroxide. FR-PO912. J Am Soc Nephrol 2015;26:576A.
  21. Kalantar-Zadeh K, Ficociello LH, Parameswaran V, Mondal H, Athienites NV, Mullon C, Kossmann RJ. Serum albumin and serum phosphorus among hemodialysis patients after initiating sucroferric oxyhydroxide. [Poster TH-PO1033] J Am Soc Nephrol 2017;28.
  22. Block et al. Association of serum phosphorus and calcium x phosphate product with mortality risk.
  23. Eriguchi R, Obi Y, Streja E, Tortorici AR, Rhee CM, Soohoo M, Kim T, Kovesdy CP, Kalantar-Zadeh K. Longitudinal associations among renal urea clearance-corrected normalized protein catabolic rate, serum albumin, and mortality in patients on hemodialysis. Clin J Am Soc Nephrol 2017;12(7):1109-17.
  24. Floege et al. Long-term effects of the iron-based phosphate binder.
  25. Velphoro® (sucroferric oxyhydroxide) prescribing information. Fresenius Medical Care North America. September 2014.
  26. Covic AC, Floege J, Ketteler M, Sprague SM, Lisk L, Rakov V, Rastogi A. Iron-related parameters in dialysis patients treated with sucroferric oxyhydroxide. Nephrol Dial Transplant 2017;32(8):1330-38.
  27. Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol 2004;15(8):2208-18.

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