Abstract

Ferric maltol Real-world Effectiveness Study in Hospital practice (FRESH): clinical characteristics and outcomes of patients with inflammatory bowel disease receiving ferric maltol for iron-deficiency anaemia in the UK

BMJ Open Gastroenterol. 2021 Feb;8(1):e000530. doi: 10.1136/bmjgast-2020-000530.

Jr Fraser Cummings 1, Aileen Fraser 2, Catherine Stansfield 3, Ian Beales 4, Shaji Sebastian 5, Sami Hoque 6

 
     

Author information

  • 1Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK Fraser.Cummings@uhs.nhs.uk.
  • 2Gastroenterology, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
  • 3Department of Gastroenterology, Salford Royal NHS Foundation Trust, Salford, UK.
  • 4Department of Gastroenterology, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK.
  • 5IBD Unit, Hull University Teaching Hospitals NHS Trust, Hull, UK.
  • 6Department of Gastroenterology, Barts Health NHS Trust, London, UK.

Abstract

Objective: To assess outcomes in patients with iron-deficient inflammatory bowel disease (IBD) treated with ferric maltol in UK real-world practice.

Design/method: This observational, multicentre, retrospective cohort study included adults with IBD and iron-deficiency anaemia (IDA; haemoglobin ≥95 to <120 g/L (women) or ≥95 to <130 g/L (men) plus serum ferritin <30 µg/L or transferrin saturation <20%) who received ferric maltol. Data were extracted from patient records. The primary analysis was the proportion of patients with normalised haemoglobin (≥120 g/L (women); ≥130 g/L (men)) over 12 weeks. Iron indices and safety were assessed.

Results: Thirty of 59 patients had data for the primary outcome, 19 of whom (63%) achieved haemoglobin normalisation at week 12. Mean±SD haemoglobin was 127±16 g/L at week 12 (increase of 14±17 g/L from baseline). Overall, 27 patients achieved haemoglobin normalisation by the end of the observation period; mean±SD time to normalisation was 49.5±25.6 days. Nine of 17 patients had normalised serum ferritin (30-300 µg/L) at week 12, and 16 patients had normalised ferritin at the end of the observation period; mean±SD time to normalisation was 71.3±27.6 days. Twenty-four adverse events occurred in 19 patients (32%); most frequent adverse events were abdominal pain or discomfort (n=9) and constipation (n=3).

Conclusion: Ferric maltol increases haemoglobin and iron indices and is generally well tolerated in patients with IBD and IDA treated in clinical practice. These real-world data support findings from randomised controlled trials.

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