Ferumoxytol versus placebo in iron deficiency anemia: efficacy, safety, and quality of life in patients with gastrointestinal disorders

Abstract

IntroductionIron deficiency anemia (IDA) is common in patients with gastrointestinal (GI) disorders and can adversely affect quality of life. Oral iron is poorly tolerated in many patients with GI disorders. Ferumoxytol is approved for the intravenous treatment of IDA in patients with chronic kidney disease. This study aimed to evaluate the efficacy and safety of ferumoxytol in patients with IDA and concomitant GI disorders.Patients and methodsThis analysis included 231 patients with IDA and GI disorders from a Phase III, randomized, double-blind, placebo-controlled trial evaluating ferumoxytol (510 mg ×2) versus placebo in patients who had failed or were intolerant of oral iron therapy. The primary study end point was the proportion of patients achieving a ≥20 g/L increase in hemoglobin (Hgb) from baseline to Week 5. Other end points included mean change in Hgb, proportion of patients achieving Hgb ≥120 g/L, mean change in transferrin saturation, and patient-reported outcomes (PROs).ResultsSignificantly more patients with IDA receiving ferumoxytol achieved a ≥20 g/L increase in Hgb versus placebo (82.1% vs 1.7%, respectively; P<0.001). Mean increase in Hgb (28.0 g/L vs −1.0 g/L, respectively; P<0.001) significantly favored ferumoxytol treatment. Ferumoxytol-treated patients demonstrated significantly greater improvements than placebo-treated patients relative to their very poor baseline PRO scores posttreatment, including improvements in the Functional Assessment of Chronic Illness Therapy–Fatigue questionnaire and various domains of the 36-Item Short-Form Health Survey. Ferumoxytol-treated patients had a low rate of adverse events.ConclusionIn this study, ferumoxytol was shown to be an efficacious and generally well-tolerated treatment option for patients with IDA and underlying GI disorders who were unable to use or had a history of unsatisfactory oral iron therapy.

Rational Management of Iron-Deficiency Anaemia in Inflammatory Bowel Disease

“…A recent phase III randomized, double-blind, placebo-controlled trial conducted at 182 sites in the United States, India and Europe evaluated administration of 510 mg doses of ferumoxytol followed by a second dose 2–8 days later in 231 patients with various gastrointestinal conditions (including IBD, polyps and colon cancer). In this study, ferumoxytol was efficacious and generally well tolerated in patients with iron-deficiency anaemia along with underlying gastrointestinal disorders who had a history of unsatisfactory oral iron supplementation [ 149 ]. However, with respect to IBD, it has been suggested that the paramagnetic nature of ferumoxytol might lead to interference during magnetic resonance imaging (MRI) examinations [ 150 ] and such interference might hamper its use in a subset of IBD patients because MRI examinations are an important diagnostic tool in their management.…”

Intravenousferric carboxymaltoseversus oral ferrous sulfate replacement in elderly patients after acute non-variceal gastrointestinal bleeding (FIERCE): protocol of a multicentre, open-label, randomised controlled trial

“…The secondary endpoints will be the following: after 1 and 3 months to enrolment, we will assess the absolute value and the causes of (1) all-cause mortality; (2) anaemiaassociated unplanned emergency visits; and (3) anaemiaassociated unplanned hospital readmission. 1 and 3 months±7 days after receiving the treatment, we will evaluate the (4) changes in quality of life measured with the SF-36 and EuroQol five-dimensions-5 levels (EQ-5D-5L) questionnaire from baseline; (5) changes in gait speed from baseline; (6) changes in 6MWT from baseline; (7) changes in handgrip strength from baseline; (8) normalisation of the Hb level (percentage of participants with Hb levels ≥12 g/dL in women and ≥13 g/dL); (9) absolute changes in Hb level, haematocrit, serum iron, serum transferrin, transferrin saturation, sTfR concentration, ferritin level, number of reticulocytes, number of erythrocytes, TIBC, erythropoietin level, CRP level, phosphate level and hepcidin level; (10) discontinuation of the treatment due to adverse events; (11) adherence to the oral treatment measured by the Medication Adherence Rating Scale (MARS) scale; and (12) cost-effectiveness.…”

“…Intravenous iron needs trained medical staff and close monitoring, available on the GIB index admission. Intravenous iron replacement may be expensive, but fewer doses are needed, and its gastrointestinal side effects are less frequent than oral iron 6 7. Besides, it results in quick restoration (3–6 weeks)8 of iron stores, a faster improvement of QoL and can guarantee adequate iron replacement in the least compliant patients 6 9.…”

Comparative safety of intravenous Ferumoxytol versus Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia: rationale and study design of a randomized double-blind study with a focus on acute hypersensitivity reactions

“…1 Therapy with oral iron is not always suitable for managing IDA because of gastrointestinal side effects, poor absorption, and often poor adherence to treatment. 3 …”