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P-143 Efficacy and Safety of intravenous Ferumoxytol for the Treatment of Iron Deficiency Anemia in Patients with IBD

BACKGROUND: Iron is essential for human bodily function: a key component of hemoglobin (Hgb) myoglobin, and metabolic enzymes. Iron deficiency anemia (IDA) is common in patients with IBD due to blood loss, inflammation and malabsorption and may negatively impact patients' health-related quality of life (HRQOL). Oral iron is often first-line treatment, but many patients do not tolerate it, or do not adequately respond; many live with chronic anemia and its related negative effects. Two, Phase-3 randomized, controlled trials recently investigated the efficacy and safety of intravenous ferumoxytol for the treatment of IDA in patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. This analysis explored the impact of intravenous iron treatment on the subgroup of IBD patients who were enrolled in these studies. METHODS: Inclusion criteria were baseline hemoglobin (Hgb) <10 g/dL and >7 g/dL, transferrin saturation (TSAT) <20%. Patients were randomized 3:1 to ferumoxytol (FER, 2 injections each 510 mg, 3–8 days apart) or placebo (PL) in Study-1, and 2:1 to FER or 1 g iron sucrose (IS, 200 mg, 5 doses over 2 weeks) in Study-2. Efficacy assessments included comparisons between treatment groups for change in Hgb, transferrin saturation (Studies-1 and -2), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score (Study-1) from Baseline to week 5. Laboratory and safety data from both studies were pooled for this subgroup analysis. RESULTS: Of 1413 patients enrolled in the 2 studies, 116 had either Crohn’s Disease (45) or ulcerative colitis (71). Their mean age was 41.6 ± 14.5 years, and the majority were female (68%) and white (75%). At week 2, and all subsequent time points, Hgb in the ferumoxytol group increased significantly over the placebo group (week 5 endpoint, 2.7 g/dL versus −0.6 g/dL, P < 0.0001) (Fig. 1, 2). These results paralleled those in the overall Study-1 population (ferumoxytol 2.7 g/dL versus placebo 0.1 g/dL, P < 0.0001). Baseline FACIT-Fatigue scores (FER, 20.2) in the IBD patients were lower than general US population norms (40.1), and comparable to anemic cancer patients receiving chemotherapy (23.9). The change in FACIT-Fatigue scores observed among patients with IBD mirrored that seen in the overall Study-1 population, where FACIT fatigue scores showed significantly greater improvement after ferumoxytol treatment than placebo (+11.7 versus +6.8 points, P < 0.001) (Fig. 3). The overall incidence of AEs was similar to that seen in the overall IDA study populations (FER, 46.1%; IS, 44.2%, PL, 43.0%) (Fig. 1). SAE rates were comparable in the Treatment Groups with 1 related SAE in the FER group. Adverse events of special interest were reported in both iron treatment groups but there were no Cardiovascular Composite Endpoint AEs among ferumoxytol patients. CONCLUSIONS: This subgroup analysis found that IBD patients with IDA, unsuccessfully treated with oral iron, had very poor baseline HRQOL scores. Treatment with ferumoxytol resulted in a substantial increase in Hgb and improved fatigue, with a safety profile similar to that seen in the overall IDA population. Figure. No caption available. Figure. No caption available. Figure. No caption available.