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.

To assess outcomes in patients with iron-deficient inflammatory bowel disease (IBD) treated with ferric maltol in UK real-world practice. 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. 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). 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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Déclaration de conflit d'intérêts

Competing interests: JFC has served as consultant, advisory board member or speaker for AbbVie, Amgen, Celltrion, Falk, Ferring, Janssen, MSD, Napp Pharmaceuticals, Pfizer, Pharmacosmos, Sandoz, Biogen, Samsung, Shield therapeutics, Vifor and Takeda. He has received research funding from Biogen, Amgen, Hospira/Pfizer, Janssen, GSK and AZ. AF has received fees for speaker services from Takeda UK, Dr Falk Pharma, Tillotts, AbbVie, Shield, Ferring, Pharmacosmos, Allergan, Actavis and Janssen and has acted on advisory boards for Takeda, Dr Falk, AbbVie, Ferring, Pharmacosmos, Allergan and Janssen. CS has received fees for speaker services from Shield Therapeutics. IB has acted on advisory boards for AbbVie, Gilead, Pharmacosmos and Vifor; has received educational grants from AbbVie, Allergan, Amgen, Genentech, Gilead, Janssen, Pfizer, Pharmacosmos, Shield, Takeda, Torax and Vifor; and has received research funding from AbbVie, Allergan, Amgen, Genentech, Gilead, Pfizer, Shield, Shire, Takeda and Vifor. SS has received grants from Takeda, Tillots Pharma and Amgen; personal fees from Takeda, Janssen, Tillots Pharma, AbbVie and Amgen; and non-financial support from Takeda, Janssen, Tillots Pharma and Abbvie.