Real-World Effectiveness of Tenapanor (XPHOZAH) for Treatment of Hyperphosphatemia in Patients on Dialysis in the United States

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Background: Tenapanor (TEN [XPHOZAH]) is approved to reduce serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy in patients (pts) who have an inadequate response to phosphate binders (PBs) or who are intolerant of any dose of PBs. This study, the first real-world (RW) study of TEN for management of serum phosphate (P), aimed to characterize RW use and effectiveness of TEN in the US dialysis setting. Methods: Electronic medical records from pts treated at a mid-size dialysis organization were used to determine within-person change in serum P before vs after TEN initiation. Pts were required to have hyperphosphatemia at baseline (serum P ≥5.5 mg/dL), have a validated TEN prescription, and have ≥1 baseline (30 to 0 days before) and post- (61 to 120 days after) TEN initiation serum P measurement. Results: The 945 pts analyzed were aged 55 years on average, 61% male, mostly white (47%), and 30% were Hispanic/Latino. Baseline mean serum P (SD) was 7.7 mg/dL (1.6; Figure) and median (Q1, Q3) parathyroid hormone was 498 pg/mL (314, 816). The mean (95% CI) within-patient change in serum P from baseline was −0.93 mg/dL (−1.1, −0.80). In the 61-120 days after TEN initiation, 48% of pts experienced a ≥1-mg/dL reduction in serum P, 29% experienced a ≥2-mg/dL reduction in serum P, and 28% achieved a post-TEN serum P of ≤5.5 mg/dL. Among a subset of patients who were prescribed TEN for ≥120 days (74%; persistent users), results were similar (Figure). Conclusion: Patients prescribed tenapanor in this real-world study experienced a reduction in serum phosphate of nearly 1 mg/dL on average. These findings support the real-world effectiveness of tenapanor for management of serum phosphate in patients with end stage kidney disease and hyperphosphatemia. Funding: Commercial Support - Ardelyx, Inc.P, phosphate.

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