Real-world safety and effectiveness of sucroferric oxyhydroxide for treatment of hyperphosphataemia in dialysis patients: a prospective observational study

Abstract

Background The iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), is indicated to control serum phosphorus levels in patients with chronic kidney disease on dialysis. Methods This non-interventional, prospective, multicentre, cohort study conducted in seven European countries evaluated the safety and effectiveness of SFOH in dialysis patients with hyperphosphataemia in routine practice. Safety outcomes included adverse drug reactions (ADRs) and changes in iron-related parameters. SFOH effectiveness was evaluated by changes-from-baseline (BL) in serum phosphorus and percentage of patients achieving in-target phosphorus levels. Results The safety analysis set included 1365 patients (mean observation: 420.3 ± 239.3 days). Overall, 682 (50.0%) patients discontinued the study. Mean SFOH dose during the observation period was 1172.7 ± 539.9 mg (2.3 pills/day). Overall, 617 (45.2%) patients received concomitant PB(s) during SFOH treatment. ADRs and serious ADRs were observed for 531 (38.9%) and 26 (1.9%) patients. Most frequent ADRs were diarrhoea (194 patients, 14.2%) and discoloured faeces (128 patients, 9.4%). Diarrhoea generally occurred early during SFOH treatment and was mostly mild and transient. Small increases from BL in serum ferritin were observed (ranging from +12 to +75 µg/L). SFOH treatment was associated with serum phosphorus reductions (6.3 ± 1.6 mg/dL at BL versus 5.3 ± 1.8 mg/dL at Month 30; ΔBL: −1.0 mg/dL, P < 0.01). Percentage of patients achieving serum phosphorus ≤4.5 mg/dL increased from 12.0% at BL to 34.8% at Month 30, while the percentage achieving serum phosphorus ≤5.5 mg/dL increased from 29.9% to 63.0%. Conclusions SFOH has a favourable safety and tolerability profile in a real-world setting, consistent with results of the Phase 3 study. Moreover, SFOH improved serum phosphorus control with a low daily pill burden.

Sucroferric oxyhydroxide for hyperphosphatemia: a review of real-world evidence

“…A total of 119 fatal events (8.7%) occurred during the study, none of which were considered related to SO treatment. Overall, the VERIFIE study confirmed that SO has a good safety and tolerability profile [43], consistent with observations in the Phase 3 trial and its extension study [26,27].…”

“…In line with the Phase 3 clinical trial program data, these studies have demonstrated that SO can effectively reduce serum phosphorus with a lower daily pill burden than many other commonly prescribed PBs, which may translate into better treatment adherence. The studies have also shown that SO is effective when prescribed in a variety of treatment settings, including as monotherapy among patients switching from other PBs [33][34][35], as first-line therapy in PB-naïve patients [36,37], or when used in combination with other PB therapies [38,43].…”

“…The long-term effectiveness of SO for serum phosphorus control was prospectively evaluated by the VERIFIE post-authorization safety study [ 43 ]. VERIFIE enrolled 1406 adult hemodialysis or peritoneal dialysis patients from seven European countries, all of whom had been prescribed SO in accordance with the product label.…”

“…In total, 1322 patients were included in the effectiveness analysis: the majority ( n = 1169; 88.4%) were receiving hemodialysis and 153 (11.6%) undergoing peritoneal dialysis [ 43 ]. SO therapy was associated with significant reductions from baseline in mean serum phosphorus (6.3 mg/dl vs 5.3 mg/dl at Month 30; Δ baseline: − 1.0 mg/dl; p < 0.01) (Fig.…”

“…A stratified analysis showed similar serum phosphorus reductions among patients who received SO in combination with other PBs and those who received SO monotherapy. The mean daily SO pill burden during the observation period was also similar between the SO monotherapy and SO combination groups (2.5 pills/day and 2.3 pills/day, respectively) [ 43 ].

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