P608 IV iron treatment of iron deficiency anaemia with ferumoxytol in patients with inflammatory bowel disease unable to take oral iron: A randomised controlled trial vs. ferric carboxymaltose

Abstract

Background: Iron deficiency anaemia (IDA) is common in patients with inflammatory bowel disease (IBD) due to multiple factors: blood loss, malnutrition, malabsorption and chronic disease. Many patients with IBD cannot take oral iron, do not tolerate it or do not adequately respond. Few studies have evaluated IV iron treatment in head‐to‐head comparisons in patients with IBD. This analysis explored the safety and efficacy of ferumoxytol (FER) compared with ferric carboxymaltose (FCM) in the subgroup of patients with IBD enrolled in a large double‐blind randomised controlled trial. Methods: Data from patients with IBD were extracted from the FIRM trial (NCT02694978) in which patients with IDA of any aetiology were randomised 1: 1 to either standard courses of FER (2 × 510 mg; N = 997) or FCM (2 × 750 mg; N = 1000), and were observed for at least 1 h following each 15 min infusion. Follow‐up visits were conducted at Weeks 2 and 5. All adverse events (AEs) considered possibly a hypersensitivity reaction (HSR) or hypotension were adjudicated by an independent blinded Clinical Events Committee. Results: In the overall study population, FER demonstrated noninferiority to FCM with respect to both the primary safety endpoint, the combined incidence of moderate to severe HSR, including anaphylaxis, or moderate to severe hypotension (FER rate: 0.6%; FCM rate: 0.7%; treatment difference:‐0.1%; 95% confidence interval [CI]:‐0.80% to +0.61%) and secondary safety endpoint, combined incidence of moderate‐to‐severe HSR, including anaphylaxis, serious cardiovascular events, or death (FER rate: 1.3%; FCM rate: 2.0%; treatment difference:‐0.7% ; 95% CI:‐1.81% to +0.42%). The subgroup of 93 patients with IBD included 43 with Crohn's disease and 50 with ulcerative colitis. Their mean age was 48.2 ± 17.7; most were female (56%) and white (88%). Among the IBD subgroup 33 (35%) patients reported AEs (30% FER, 41% FCM), of which 21 AEs in 14 (15%) patients (11% FER, 20% FCM) were treatment related. None of the related AEs were rated serious. Hypophosphataemia <0.6 mmol/l [CTCAE Grade 3 (severe)] occurred in 13 (31%) of FCM patients and no FER patients. Mean haemoglobin increased significantly (p < 0.01) from baseline to Week 5 in both groups (FER from 10.3 to 12.2 g/dl and FCM from 10.2 to 12.5 g/dl). (Figure presented) Conclusions: These results indicate that patients with IBD who had not tolerated or responded to oral iron responded to both IV FER and FCM with a significant increase in haemoglobin and an adverse event profile comparable to that seen in the overall study population.