New Data Show Oral Ferric Maltol (FERACCRU) May Be a Cost-effective Alternative to Intravenous (IV) Carboxymaltose With at Least as Great Benefits in the Quality of Life of Patients With Iron Deficiency Anaemia and Inflammatory Bowel Disease - Seite 3

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Notes to Editors:

About the post hoc analyses

Patients with IBD and IDA (haemoglobin [Hb] ≥8.0 g/dL and ≤11.0 g/dL for women or ≥8.0 g/dL and ≤12.0 g/dL for men, and ferritin <30 ng/mL or ferritin <100 ng/mL with transferrin saturation <20%) were randomised to FM (30 mg b.d.) or IV FCM (as per local Summary of Product Characteristics [SmPC] or prescribing information) in an open-label, Phase 3b non-inferiority study. The primary endpoint was Hb responder rate (proportion of patients achieving a ≥2 g/dL increase or normalisation of Hb at week 12). 250 patients were randomised: 125 to FM (per-protocol [PP] n=86) and 125 to IV FCM (PP n=93). The Hb responder rate for oral FM was non-inferior to IV FCM in the PP population (74% vs 83%); risk difference was -0.1 (two-sided p=0.017; 95% CI -0.2, 0.0), within the pre-defined non-inferiority margin of 20% difference.

For the post hoc analysis 'Impact of oral ferric maltol and IV iron on health-related quality of life in patients with iron deficiency anaemia and inflammatory bowel disease, and relationship with haemoglobin and serum iron', patients with IBD and IDA were randomised to FM (30 mg b.d) or IV FCM (as per local SmPC) with primary endpoint Hb responder rate [proportion of patients with ≥2 g/dL increase or normalisation of Hb at week 12; non-inferiority margin 20%]. HRQoL was assessed via the Short Form Health Survey (SF-36). In the post hoc analysis of patient-level data, Hb, serum iron and HRQoL at baseline and week 12 were summarised descriptively and correlations between HRQoL and haematological parameters were assessed via Pearson's correlation coefficient (PCC). Hb, serum iron and HRQoL all improved following both treatments at Week 12. Improvements in SF-36 physical component summary (PCS) and mental component summary (MCS) scores were slightly greater with FM (difference not statistically significant). HRQoL improved across all SF-36 domain scores with both FM and FCM, with no statistically significant differences between treatments. HRQoL (MCS and PCS) improvements were positively associated with increases in Hb and serum iron. ^[3] 

For the post hoc analysis 'Productivity loss in patients with inflammatory bowel disease receiving treatment for iron deficiency anaemia: a comparison of ferric maltol and IV iron' Productivity loss was calculated based on the number of days lost due to iron therapy during the initial 12-week study period. The costs associated with lost productivity were calculated using the human capital approach and based on the average gross income from Germany. IV FCM treatment resulted in a loss of patient time because IV administration was limited to an outpatient setting: 50% of patients treated with IV FCM lost at least one full day due to treatment, with 1 in 15 losing 4-6 days. Productivity loss was quantified, with IV FCM treatment associated with losses between €0.00 and €107.21 in 50% of patients, €129.17 and €387.51 in 43% of patients and €516.68 and €775.02 in 7% of patients. FM was administered orally by the patient and did not require any in-clinic treatment, there was no treatment linked productivity loss. ^[2]