Treatment with ferumoxytol for patients with iron deficiency anemia (IDA) and comorbid gastrointestinal disorders was found to be efficacious and generally well-tolerated in an analysis of a Phase 3 trial.
Ferumoxytol is currently the only approved treatment for IDA patients with chronic kidney disease. The primary trial included a total of 231 patients with IDA and GI disorders, and was conducted across 182 sites in the U.S., Canada, Poland, Hungary, Latvia, and India.
Patients were randomized to receive ferumoxytol (n=173) or placebo (n=58). The primary endpoint of the study was the proportion of patients achieving a ≥20g/L increase in hemoglobin (Hgb) from baseline to Week 5.
Results showed that a total of 82.1% of the ferumoxytol-treated patients achieved an increase in Hgb of ≥20g/L from baseline to Week 5, compared to 1.7% of the placebo-treated patients (treatment difference [TD]: 80.4%; P<0.001).
In addition, 51% of ferumoxytol-treated patients achieved a Hgb level of ≥120g/L at one time from baseline to Week 5 vs. none in the placebo group (TD: 51.4%; P<0.001). The mean change in transferrin saturation (TSAT) values from baseline to Week 5 was also greater for ferumoxytol-treated patients vs. the placebo-treated group (TD: 11.2%; P<0.001).
Regarding adverse events (AEs), a greater number of AEs occurred in the ferumoxytol group than the placebo group: 11.6% compared to 3.4%, respectively. Moreover, no treatment-emergent adverse events (TEAEs) occurred in >5.2% of patients in either treatment arm the GI subgroup. Nausea (5.2%), headache (4.6%), and dizziness (3.5%) were the most common TEAEs reported.
The study authors conclude that, “Ferumoxytol may provide an additional option for the treatment of IDA in patients with an underlying GI disorder,” especially those who have a history of unsatisfactory oral iron therapy or those who cannot be given oral iron.
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