Efficacy | VELPHORO® (sucroferric oxyhydroxide)

UNIQUELY VELPHORO: LONG-TERM, REAL-WORLD DATA1-3


In a 2-year real-world analysis with a novel comparator design...

More patients who stayed on Velphoro reached goal than those who switched to another binder*1

Phosphorus control: 2-year results (N=818)*1

More patients who stayed on Velphoro reached goal than those who switched to another binder, and took half the pills
More patients who stayed on Velphoro reached goal than those who switched to another binder, and took half the pills
More patients who stayed on Velphoro reached goal than those who switched to another binder, and took half the pills

In multiple real-world retrospective analyses‡§2,3

Double the percentage of patients reached goal with half the pills
Double the percentage of patients reached goal with half the pills
Double the percentage of patients reached goal with half the pills

In the largest registrational clinical study of phosphate binders...

With Velphoro monotherapy, patients maintained phosphorus control with HALF as many tablets as sevelamer‖4-6

Phosphorus reduction and tablets per day from the clinical study

Velphoro sustained control of phosphorus levels 3-4 pills per day
Velphoro sustained control of phosphorus levels 3-4 pills per day
Velphoro sustained control of phosphorus levels 3-4 pills per day

In another 6-month, real-world retrospective analysis...

Peritoneal dialysis: More patients who switched to Velphoro achieved phosphorus control with fewer pills#7

6-month results in patients on peritoneal dialysis (N=258)#7

After 6 months, 72% more patients who switched to Velphoro achieved phosphorus control with fewer pills
After 6 months, 72% more patients who switched to Velphoro achieved phosphorus control with fewer pills
After 6 months, 72% more patients who switched to Velphoro achieved phosphorus control with fewer pills

*A retrospective analysis of deidentified clinical and prescription data from 818 hemodialysis patients extracted from the Fresenius Kidney Care clinical data warehouse and Fresenius pharmacy database. Clinical and laboratory parameters of 222 patients who continued Velphoro monotherapy for 24 months from baseline beginning between April 1, 2014, and April 1, 2015, were compared to 596 patients who discontinued Velphoro and were switched to alternate phosphate binders within 90 days of baseline. The decision to switch phosphate binders was made on a clinical basis and the reasons underlying this change were not available. Outcomes included achievement of target serum phosphorus of ≤5.5 mg/dL and phosphate binder pill burden.1

Presenter is a paid speaker and has been compensated for their time.

A retrospective analysis of deidentified pharmacy data from 1,029 adult in-center hemodialysis patients who were switched to Velphoro during routine care between April 2014 and March 2015. The decision to switch phosphate binders (PBs) was made on a clinical basis and the reasons underlying this change were not available. Outcomes included the proportion of patients with phosphorus levels ≤5.5 mg/dL and the mean prescribed PB pills/day at baseline (3 months prior to Velphoro) and during Velphoro follow-up (6 months after switch to Velphoro, n=424).2

§A retrospective analysis of deidentified pharmacy data from 530 adult in-center hemodialysis patients who were switched to Velphoro during routine care between March 2014 and March 2015. The decision to discontinue baseline phosphate binders (PBs) and switch to Velphoro was made on a clinical basis and the reasons underlying this change were not available. Comparisons were made between the 91-day period before Velphoro initiation (ie, baseline) and the 4 consecutive 91-day intervals of Velphoro treatment (Q1-Q4). Main outcome measures included achievement of target phosphorus levels (≤5.5 mg/dL) and mean number of PB pills/day.3

A 52-week, open-label, active-controlled, phase 3 study evaluated the safety and efficacy of Velphoro in lowering serum phosphorus levels in patients (N=1,054) with chronic kidney disease on hemodialysis or peritoneal dialysis. In the titration phase (first 24 weeks), patients were randomized to receive either Velphoro or sevelamer carbonate to establish the noninferiority of Velphoro to sevelamer carbonate in lowering serum phosphorus at 12 weeks (secondary endpoint). The following withdrawal phase (weeks 24 to 27, n=93) established the superiority of Velphoro with an effective maintenance dose over a placebo-like low dose (primary endpoint). During a final long-term maintenance phase (weeks 28-52, n=658), patients continued phosphate binder treatment according to their original randomization for the assessment of long-term efficacy, safety, and tolerability.4,6

During the maintenance phase (weeks 28-52), patients on Velphoro averaged 4.0 tablets per day compared to 10.1 pills per day with sevelamer carbonate. In the integrated 1-year comparison (weeks 0-24 and 28-52), patients on Velphoro took an average of 5.4 fewer tablets per day: 5.4 x 365 = 1,971.6

#A retrospective analysis of deidentified pharmacy data from adult peritoneal dialysis patients (n=258) prescribed Velphoro as part of routine clinical care between April 1, 2014, and October 30, 2015. The decision to switch phosphate binders (PBs) was made on a clinical basis and the reasons underlying this change were not available. Primary outcomes were total daily PB pill burden, serum phosphorus, and percentage of patients with serum phosphorus ≤5.5 mg/dL.7

References: 1. Coyne DW, Ficociello LH, Parameswaran V, et al. Sucroferric oxyhydroxide in maintenance hemodialysis: a retrospective, comparative cohort study. Kidney Med. 2020;2(3):307-316. 2. Coyne DW, Ficociello LH, Parameswaran V, et al. Real-world effectiveness of sucroferric oxyhydroxide in patients on chronic hemodialysis: a retrospective analysis of pharmacy data. Clin Nephrol. 2017;88(2):59-67. 3. Kendrick J, Parameswaran V, Ficociello LH, et al. One-year historical cohort study of the phosphate binder sucroferric oxyhydroxide in patients on maintenance hemodialysis. J Ren Nutr. 2019;29(5):428-437. 4. Velphoro® [package insert]. Waltham, MA: Fresenius Medical Care North America; 2020. 5. Data on file. Fresenius Medical Care North America, Waltham, MA. 6. Floege J, Covic AC, Ketteler M, et al; on behalf of the Sucroferric Oxyhydroxide Study Group. Long‐term effects of the iron‐based phosphate binder, sucroferric oxyhydroxide, in dialysis patients. Nephrol Dial Transplant. 2015;30(6):1037‐1046. 7. Kalantar-Zadeh K, Parameswaran V, Ficociello L, et al. Real-world scenario improvements in serum phosphorus levels and pill burden in peritoneal dialysis patients treated with sucroferric oxyhydroxide. Am J Nephrol. 2018;47(3):153-161.