PWE-013 Feraccru® real world effectiveness study in hospital practice (fresh): an interim analysis

Introduction Many patients with inflammatory bowel disease (IBD) experience iron deficiency anaemia (IDA), which can impact significantly on quality of life (QoL). Oral ferric maltol (Feraccru) is a novel iron complex licensed in the UK for the treatment of IDA in patients with IBD. The aim of this study is to understand the early experiences of Feraccru in patients with IBD and IDA in the UK, including treatment effectiveness, patterns of use and tolerability. Methods FRESH is an ongoing observational cohort study conducted in 5 secondary care gastroenterology centres in the UK (up to 8 centres planned). Data were collected from hospital medical records for consenting adult patients (≥18 years) with Crohn’s disease (CD), ulcerative colitis (UC) or unspecified IBD who were also diagnosed with mild or moderate IDA and initiated on Feraccru since June 2016. Patients with an IBD flare at time of study recruitment, and/or requiring corticosteroids to treat flares at time of Feraccru initiation were not eligible for the study. Interim data for the first 30 patients recruited to the study are presented. Results The mean (SD) age of 30 patients at initiation of Feraccru was 42.2 (15.8) years and 37% (n=11) of patients were male. Of these patients, 50% (n=15) had CD, 43% (n=13) had UC and 7% (n=2) had IBD of unspecified type. The mean haemoglobin (Hb) level at initiation was 10.7 g/dL (standard deviation 12.1 g/dL). At 12 weeks after initiation of Feraccru (permitting a measurement window from 10 to 16 weeks), 62% (n=8) of 13 patients with a measurement recorded had normalised Hb levels (defined as Hb ≥12.0 g/dL for females and ≥13.0 g/dL for males). Out of 30 patients who received Feraccru, 10% (n=3) discontinued by week 4 (+1 week) and 23% (n=7) by week 12 (+4 weeks). No patients discontinued Feraccru due to lack of efficacy. Conclusions The first results from a study of the use and outcomes of Feraccru in UK clinical practice show that in the small sample less than half of patients had a recorded Hb measurement at 12 weeks after initiation of Feraccru. Of those who did, 62% had normalised Hb. This is comparable to results from the AEGIS phase III study where 66% patients achieved normalised Hb by 12 weeks.