#3219 Comparative effectiveness of etelcalcetide versus cinacalcet for the treatment of secondary hyperparathyroidism in patients in haemodialysis: a population-based study in Lazio, Italy

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Abstract Background and Aims Secondary hyperparathyroidism (SHP) is a clinically significant complication commonly present in chronic renal disease, especially in patients on haemodialysis. Pharmacological therapy aims to reduce the level of parathyroid hormone (PTH). Among specific treatments, the long-acting calcimimetic etelcalcetide was authorised in Italy a few years ago based on clinical trial results. However, real-world evidence of its efficacy remains limited. This study, founded by the Italian Medicines Agency (Pharmacovigilance call 2012–14), aims to perform a comparative evaluation of SHP control with the use of the two calcimimetics etelcalcetide and cinacalcet in patients on chronic haemodialysis in a real-world setting. Method A cohort of new users of cinacalcet and etelcalcetide from the Lazio Regional Dialysis and Transplantation Registry, covering the years 2018–2020, was enrolled. Study endpoints were retrieved through an ad hoc survey in regional dialysis centres. Indicators of SHP control were serum levels of PTH, phosphorus and calcium, which were evaluated by comparing the proportions of patients at target and mean blood levels at baseline, 12 and 24 months of observation. Results Overall, 652 haemodialytic patients were enrolled, 59% males and a mean age of 64 years. The majority of patients (500) began treatment with etelcalcetide. In both treatment groups, serum PTH improved over time, as evidenced by an increased proportions of patients achieving the therapeutic target (etelcalcetide from 37.8 at baseline to 59.3% at 24 months; cinacalcet from 39.5 to 63.3%) and a significant decrease of PTH blood levels (etelcalcetide from 605.2 to 372.9 pg/mL; cinacalcet from 577.9 to 285.1 pg/mL). Serum phosphorus levels also showed improvements over time, with more patients reaching target levels (etelcalcetide from 23.0 to 36.0%; cinacalcet from 19.1 to 26.7%). however mean blood levels decreased in cinacalcet users only. Results for serum calcium levels were less promising, with no change over time in the proportion of cinacalcet users reaching target levels, while etelcalcetide users saw a decrease. Mean calcium levels remained stable across both treatment groups. Conclusion The present study shows improvements in SHP control in both treatment groups with negligible differences between the two. Along with previous findings of a mortality reduction in patients treated with etelcalcetide with respect to cinacalcet, with a borderline statistical significance, this study confirms the efficacy and safety of etelcalcetide in SHP treatment in patients in haemodialysis.

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