Safety and Efficacy of Intravenous Ferric Derisomaltose Compared to Iron Sucrose for Iron Deficiency Anemia in Patients with Chronic Kidney Disease With and Without Heart Failure

Abstract

Ferric derisomaltose (FDI) is an intravenous (IV) high-dose iron formulation approved in the US for the treatment of iron deficiency anemia in adults who are intolerant of/have had an unsatisfactory response to oral iron, or who have non-dialysis-dependent chronic kidney disease (NDD-CKD). FERWON-NEPHRO was a randomized, open-label, multicenter clinical trial evaluating the safety and efficacy of a single infusion of FDI 1,000 mg versus up to 5 doses of iron sucrose (IS) 200 mg (recommended cumulative dose, 1,000 mg) over 8 weeks in patients with NDD-CKD and iron deficiency anemia. Of 1,525 patients included in the safety analysis, 244 (16%) had a history of heart failure (HF). Overall, the rate of serious or severe hypersensitivity reactions was low and did not differ between treatment groups. Cardiovascular adverse events (AEs) were reported for 9.4% of patients who had HF and 4.2% who did not. Time to first cardiovascular AE was longer following administration of FDI compared with IS (hazard ratio: 0.59 [95% CI: 0.37, 0.92]; p=0.0185), a difference that was similar in patients with or without HF (p=0.908 for interaction). Patients achieved a faster hematological response (assessed by changes in hemoglobin and ferritin concentrations, and increase in transferrin saturation) with FDI versus IS. In conclusion, in patients with NDD-CKD, a single infusion of FDI was safe, well tolerated, and was associated with fewer cardiovascular AEs and a faster hematological response, compared to multiple doses of IS. These effects were similar for patients with and without HF. Ferric derisomaltose (FDI) is an intravenous (IV) high-dose iron formulation approved in the US for the treatment of iron deficiency anemia in adults who are intolerant of/have had an unsatisfactory response to oral iron, or who have non-dialysis-dependent chronic kidney disease (NDD-CKD). FERWON-NEPHRO was a randomized, open-label, multicenter clinical trial evaluating the safety and efficacy of a single infusion of FDI 1,000 mg versus up to 5 doses of iron sucrose (IS) 200 mg (recommended cumulative dose, 1,000 mg) over 8 weeks in patients with NDD-CKD and iron deficiency anemia. Of 1,525 patients included in the safety analysis, 244 (16%) had a history of heart failure (HF). Overall, the rate of serious or severe hypersensitivity reactions was low and did not differ between treatment groups. Cardiovascular adverse events (AEs) were reported for 9.4% of patients who had HF and 4.2% who did not. Time to first cardiovascular AE was longer following administration of FDI compared with IS (hazard ratio: 0.59 [95% CI: 0.37, 0.92]; p=0.0185), a difference that was similar in patients with or without HF (p=0.908 for interaction). Patients achieved a faster hematological response (assessed by changes in hemoglobin and ferritin concentrations, and increase in transferrin saturation) with FDI versus IS. In conclusion, in patients with NDD-CKD, a single infusion of FDI was safe, well tolerated, and was associated with fewer cardiovascular AEs and a faster hematological response, compared to multiple doses of IS. These effects were similar for patients with and without HF. Ferric derisomaltose (FDI), previously known as iron isomaltoside, is an intravenous (IV) high-dose iron formulation. Since its approval by the European Medicines Agency in 2009, FDI has been commercially available for the treatment of iron deficiency in several European countries. In 2020, the US Food and Drug Administration (FDA) approved FDI for the treatment of iron deficiency anemia in adults who are either intolerant of or have had an unsatisfactory response to oral iron, or who have non-dialysis-dependent chronic kidney disease (NDD-CKD). FDA approval was based on two randomized, open-label, multicenter trials, FERWON-IDA1Auerbach M Henry D Derman RJ Achebe MM Thomsen LL Glaspy J. A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial.Am J Hematol. 2019; 94: 1007-1014Crossref PubMed Scopus (34) Google Scholar and FERWON-NEPHRO.2Bhandari S Kalra PA Berkowitz M Belo D Thomsen LL Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrol Dial Transplant. 2021; 36: 111-120Crossref PubMed Google Scholar FERWON-IDA included younger patients (mean age 44 years) with iron deficiency anemia, mainly women (89%),1Auerbach M Henry D Derman RJ Achebe MM Thomsen LL Glaspy J. A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial.Am J Hematol. 2019; 94: 1007-1014Crossref PubMed Scopus (34) Google Scholar and only 16 had heart failure (HF) (unpublished data). FERWON-NEPHRO reported that, in patients with NDD-CKD, a single dose of FDI resulted in a rapid hematological response (improvements in iron indices and hemoglobin), was well-tolerated, and was associated with fewer cardiovascular adverse events (AEs) compared with multiple doses of iron sucrose (IS).2Bhandari S Kalra PA Berkowitz M Belo D Thomsen LL Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrol Dial Transplant. 2021; 36: 111-120Crossref PubMed Google Scholar For patients with HF, iron deficiency and anemia are common and associated with more severe symptoms, poorer quality of life, reduced exercise capacity, impaired renal function and a worse prognosis.3Ambrosy AP Gurwitz JH Tabada GH Artz A Schrier S Rao SV Barnhart HX Reynolds K Smith DH Peterson PN Sung SH Cohen HJ Go AS; RBC Heart Investigators. Incident anaemia in older adults with heart failure: rate, aetiology, and association with outcomes.Eur Heart J Qual Care Clin Outcomes. 2019; 5: 361-369Crossref PubMed Scopus (6) Google Scholar, 4Ambrosy AP Fitzpatrick JK Tabada GH Gurwitz GH Artz A Schrier SL Rao SV Reynolds K Smith DH Peterson PN Fortmann SP Sung SH Cohen HJ Go AS; RBC Heart Investigators/PACTTE Consortium. 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The of of the FERWON-NEPHRO trial was to the safety and hematological efficacy of FDI versus IS in patients with NDD-CKD and iron deficiency anemia, with or without a history of HF. FERWON-NEPHRO was a randomized, open-label, multicenter trial to the safety and efficacy of FDI versus IS American in patients with NDD-CKD and iron deficiency S Kalra PA Berkowitz M Belo D Thomsen LL Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrol Dial Transplant. 2021; 36: 111-120Crossref PubMed Google Scholar was by rate at by the of in or at a of of cardiovascular disease based on the S Kalra PA Berkowitz M Belo D Thomsen LL Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrol Dial Transplant. 2021; 36: 111-120Crossref PubMed Google Scholar Iron deficiency anemia was as hemoglobin and a ferritin the transferrin saturation was S Kalra PA Berkowitz M Belo D Thomsen LL Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrol Dial Transplant. 2021; 36: 111-120Crossref PubMed Google Scholar the dose of had to for weeks to S Kalra PA Berkowitz M Belo D Thomsen LL Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrol Dial Transplant. 2021; 36: 111-120Crossref PubMed Google Scholar Patients were randomized to treatment with FDI dose of 1,000 mg) or IS mg up to 5 the first to the with a cumulative dose of 1,000 mg) and were up for 8 weeks to the of serious or severe hypersensitivity reactions and the in as S Kalra PA Berkowitz M Belo D Thomsen LL Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrol Dial Transplant. 2021; 36: 111-120Crossref PubMed Google Scholar of were as a efficacy S Kalra PA Berkowitz M Belo D Thomsen LL Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrol Dial Transplant. 2021; 36: 111-120Crossref PubMed Google Scholar safety included the of a of cardiovascular and the of as S Kalra PA Berkowitz M Belo D Thomsen LL Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrol Dial Transplant. 2021; 36: 111-120Crossref PubMed Google Scholar The and of the have been S Kalra PA Berkowitz M Belo D Thomsen LL Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrol Dial Transplant. 2021; 36: 111-120Crossref PubMed Google Scholar The safety included 1,525 randomized patients who dose of trial S Kalra PA Berkowitz M Belo D Thomsen LL Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrol Dial Transplant. 2021; 36: 111-120Crossref PubMed Google Scholar The included randomized patients who dose of trial and who had of S Kalra PA Berkowitz M Belo D Thomsen LL Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrol Dial Transplant. 2021; 36: 111-120Crossref PubMed Google Scholar For analysis, from FERWON-NEPHRO were to or not a history of HF was in the report at HF was the for failure The of serious or severe hypersensitivity and cardiovascular were reactions and cardiovascular AEs were by a Clinical to treatment between FDI and IS were for the safety The to first cardiovascular AE was the and was a For a was with iron and of HF as from to and 8 in and were and in was at and 8 the of less in response between FDI and IS were for the a for with and as and as a were to in response in and for FDI compared to IS in patients with and without HF. A of was for were Of patients S Kalra PA Berkowitz M Belo D Thomsen LL Wolf M. 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The of AEs and serious AEs was similar of iron the to first cardiovascular AE was longer in to with a in patients with or without HF. difference was by a in HF of HF at patients with HF, the of adverse reactions or was low after the administration of FDI and IS. of HF the hematological response was faster to FDI to similar effects were achieved by to 8 is the first to the effects of FDI in patients with HF from a randomized controlled The rate of cardiovascular AEs was for patients with HF compared to without HF. in the in the of cardiovascular AEs with FDI compared to IS was similar the had HF (hazard ratio: or did not have HF (hazard ratio: a for patients with HF compared to without HF is an of HF and was reported in fewer the G N A S N McDonagh T M G of iron isomaltoside on in patients with chronic heart failure and iron deficiency.Circulation. 2019; PubMed Scopus Google Scholar that treatment with FDI reduced P a of the of at the American of Cardiology The AFFIRM-AHF trial has shown that patients with a ejection fraction and iron deficiency from acute HF, treatment with ferric carboxymaltose high-dose IV iron reduced the of for HF, had on cardiovascular P Kirwan B-A Anker SD McDonagh T Dorobantu M Drozdz J Fabien V Filippatos G Göhring UM Keren A Khintibidze I Kragten H Martinez FA Metra M Milicic D Nicolau JC Ohlsson M Parkhomenko A Pascual-Figal DA Ruschitzka F Sim D Skouri H van der Meer P Lewis BS Comin-Colet J von Haehling S Cohen-Solal A Danchin N Doehner W Dargie HJ Motro M Butler J Friede T Jensen KH Pocock S Jankowska EA AFFIRM-AHF investigatorsFerric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial.Lancet. 2020; 396: 1895-1904Abstract Full Text Full Text PDF PubMed Scopus (124) Google Scholar of randomized trials that, compared to IV iron the of hospitalizations for SD Kirwan van Veldhuisen DJ Filippatos G Comin-Colet J Ruschitzka F Lüscher TF Motro M Mori C Roubert B Pocock SJ Ponikowski P. of ferric carboxymaltose on and mortality in heart failure patients: an J Heart PubMed Scopus Google Pellicori P I Kalra Cleland iron for heart failure with of iron a of Res Cardiol. 2021; of PubMed Scopus (6) Google Scholar an in with IV P Voors AA Anker SD Bueno H Cleland JGF Coats AJS Falk V Gonzàlez-Juanatey JR Harjola V-P Jankowska EA Jessup M Linde C Nihoyannopoulos P Parissis JT Pieske B Riley JP Rosano GMC Ruilope LM Ruschitzka F Rutten FH van der Meer P ESC Scientific Document Group2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: the task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) developed with the special contribution of the Heart Failure Association (HFA) of the ESC.Eur Heart J. 2016; 37: 2129-2200Crossref PubMed Scopus (7425) Google Scholar trials and are evaluating the of IV iron on morbidity and mortality in patients with HF. 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