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.


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.

© Copyright 2013-2023 GI Health Foundation. All rights reserved.
This site is maintained as an educational resource for US healthcare providers only. Use of this website is governed by the GIHF terms of use and privacy statement.