Results from the FERWON-IDA trial (ClinicalTrials.gov Identifier: NCT02940886) demonstrated that iron isomaltoside 1000 with ferric derisomaltose (IIM), which results in slow release of bioavailable iron, led to a more rapid hematologic response compared with iron sucrose during the first 2 weeks of treatment in patients with iron deficiency anemia. Additionally, the 2 treatments showed similar safety profiles.
The study, published in the American Journal of Hematology, was a prospective, multicenter, randomized comparison that aimed to evaluate the safety and efficacy of IIM and iron sucrose in a broad population of patients with iron deficiency anemia. The primary end points were a change in hemoglobin from baseline to week 8 and adjudicated serious or severe hypersensitivity reactions.
A total of 1512 patients were assigned in a 2 to 1 ratio to receive either 1000 mg IIM as a single infusion (1009 patients) or 200 mg iron sucrose intravenously up to 5 times (503 patients).
The efficacy end point demonstrated noninferiority in hemoglobin change between the 2 treatment groups from baseline to week 8. Patients receiving IIM showed a more rapid hematologic response in the first 2 weeks compared with patients in the iron sucrose group (P <.0001). However, the median time to hemoglobin increase of at least 2 g/dL was 28 days in both groups (P =.088).
There were no differences in serious or severe hypersensitivity reactions between the groups, with frequencies of 0.3% (95% CI, 0.06%-0.88%) in the IIM group and 0.4% (95% CI, 0.05%-1.45%) in the iron sucrose group.
The frequencies of adverse events were low and nonsignificant in both groups. Of note, the frequencies of cardiovascular events and hypophosphatemia were 0.8% and 3.9%, respectively, in the IIM group and 1.2% and 2.3%, respectively, in the iron sucrose group.
1. Auerbach M, Henry D, Derman RJ, Achebe MM, Thomsen LL, Glaspy J. A prospective, multicenter, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia (the FERWON-IDA trial) [published online June 26, 2019]. Am J Hematol. doi:10.1002/ajh.25564