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.

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.