Ferumoxytol may improve PROs in patients with anaemia
Use of a single course of the intravenous iron preparation ferumoxytol may lead to sustained improvements in patient-reported outcomes (PROs) of individuals with iron deficiency anaemia (IDA) who had inadequate response to oral iron therapy, according to data presented at ASH 2018.
“[T]hese benefits include reductions in fatigue, increased energy, vitality, and ability to perform activities of daily living (ADL), and improved health-related quality of life (HRQoL),” said the researchers.
This open-label 6-month extension phase included 471 individuals (mean age 43.6 years, 90 percent female) previously enrolled in a 5-week double-blind trial comparing ferumoxytol (2 x 510 mg) against placebo or iron sucrose (5 x 200 mg). Participants with persistent or recurrent IDA (haemoglobin <11.0 g/dL, transferrin saturation <20 percent) were retreated with the same ferumoxytol course 3–8 days apart. Those who failed to meet the retreatment criteria (61 percent; n=285) did not receive any further doses of ferumoxytol. [ASH 2018, abstract 1050]
Although ferumoxytol treatment was not extended to those who did not meet the retreatment criteria, these patients continued to exhibit a mean haemoglobin score of >12.0 throughout the extension phase (12.1 at month 7), indicating sustained improvement from the double-blind phase score of 12.1.
There was a slight increase in the mean FACIT-Fatigue* score from the double-blind to the extension phase (from 36.1 to 38.8 at month 7). This was a significant increase from the baseline score of 24.3, which according to the researchers, was lower than the normal range for the general US non-anaemic population (40.1–43.6) and comparable to those of anaemic cancer patients undergoing chemotherapy (23.9).
Mean SF-36 Vitality** score also increased slightly from the double-blind to the extension phase (from 47.7 to 50.9 at month 7), which approximates the general US population normal score of 50.0. [Med Care 1993;31:247-263]
Significant improvements were also observed in the mean LASA*** scores at month 7 compared with the baseline scores (from 36.8 to 53.7 for LASA-Energy, 44.8 to 59.7 for LASA-ADL, and 48.6 to 61.5 for LASA-QoL).
Overall, the sustained improvements in the extension phase reflect the durability of the treatment effect of ferumoxytol, said the researchers.
Although patients with IDA are typically treated with oral iron, some exhibit failed responses or are intolerant to the regimen especially in cases of chronic anaemia, noted the researchers. “Iron deficiency … requires treatment to replete iron stores … [Our findings are] important especially in light of the poor baseline energy and HRQoL scores of patients who cannot take oral iron,” said the researchers.