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P485. IV iron treatment of iron deficiency anaemia with Ferumoxytol in patients with gastrointestinal disorders unable to take oral iron: a randomized controlled trial versus iron sucrose

D. Hetzel1, W. Strauss2, K. Bernard3, J. Li3, L. Allen3, 1Royal Adelaide Hospital, Gastroenterology & Hepatology, Adelaide, Australia, 2AMAG pharmaceuticals Inc, Medical Director, Lexington MA, United States, 3AMAG pharmaceuticals Inc, Lexington MA, United States

Background

Iron deficiency anaemia (IDA) is common in patients with gastrointestinal (GI) disease due to multiple factors: blood loss, malnutrition, malabsorption and chronic disease. While oral iron is the preferred first-line treatment for patients with IDA, many patients cannot take oral iron, do not tolerate it or do not adequately respond. Oral iron may be inappropriate or ineffective for some patients, often the case in patients with inflammatory bowel disease. Ferumoxytol (FER) is an IV iron approved in the USA, Canada, Switzerland and the EU for the treatment of IDA in adult patients with chronic kidney disease with a dosing regimen that permits the delivery of a full 1 g course of iron in 2 510 mg doses, 3–8 days apart. Few studies have evaluated IV iron treatment in head-to-head comparisons. This randomized, controlled trial was designed to investigate the efficacy and safety of FER compared to iron sucrose (IS) for the treatment of IDA in patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.

Methods

This multicentre open label study was designed to demonstrate the non-inferiority (NI) of FER to IS. GI patients (n = 204) with IDA, (haemoglobin 7–10 g/dL and transferrin saturation <20%) were randomized 2:1 to receive either 2 injections each of 17 ml FER 510 mg (n = 138), 2 to 8 days apart, or 5 infusions or injections each of IS 200 mg (n = 66) over 14 days. Efficacy and safety assessments were conducted weekly from Baseline to Week 5.

Results

FER was shown to be non-inferior (NI) to IS in the proportion of subjects with a >2 g/dL increase in haemoglobin (Hgb) at any time from Baseline to Week 5 (FER, 80.4%; IS 80.3%) with the lower bound of the 95% CI (−11.5%) above the predefined NI margin (−15%). FER also achieved NI to IS in the mean change in Hgb from Baseline to Week 5 with a 2.7 g/dL increase in Hgb compared to 2.5 g/dL with IS. The incidence of overall AEs was similar between the two treatment groups: 71 (34.8%) subjects reported Adverse Events (AEs 34% FER, 36% IS), of which 41 AEs in 22 (10.8%) subjects (8.7% FER, 15.2% IS) were treatment related. Serious Adverse Events (SAEs) were reported at comparable frequencies (3.6% FER, 3.0% IS), and no treatment related SAEs were reported.

Conclusion

In this randomized, controlled trial, the efficacy and safety of 2 doses of FER were comparable to 5 doses of IS in treating GI patients with IDA and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.