P567 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

Abstract

Background Iron deficiency anaemia (IDA) is common in inflammatory bowel disease (IBD) and can significantly impair health-related quality of life (HRQoL). IV iron is currently the main treatment for patients intolerant or unsuitable for standard oral iron. Ferric maltol (FM), a stable oral complex of ferric iron and maltol, is designed to provide efficient iron delivery and minimise formation of free iron in the gut, thus reducing the potential for gastric adverse events. The HRQoL benefits of FM and ferric carboxymaltose (FCM) and their relationship to haematological parameters were analysed using data from a randomised controlled trial. Methods Patients with IBD and IDA were randomised to FM (30 mg b.i.d) or IV FCM (as per local SmPC) in an open-label, Phase 3b non-inferiority study (primary endpoint haemoglobin [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 a 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). Results 250 patients were randomised: 125 to FM (per-protocol [PP] n = 86) and 125 to IV FCM (PP n = 92). FM was non-inferior to FCM on the primary endpoint (response rate 74% and 83% for FM and IV FCM respectively [PP population], risk difference -0.1 [two-sided p = 0.017; 95% CI -0.2, 0.0]). 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; Table 1). HRQoL improved across all SF-36 domain scores with both FM and FCM, with no statistically significant differences between treatments (Figure 1). HRQoL (MCS and PCS) improvements were positively associated with increases in Hb and serum iron (Table 1). Conclusion FM provides non-inferior efficacy to IV FCM with at least as great a benefit to HRQoL and may, therefore, provide an oral alternative to IV iron in patients with IBD.

Ferric Maltol: A New Oral Iron Formulation for the Treatment of Iron Deficiency in Adults

“…The active-comparator trial of FM, AEGIS-H2H, was a prospective, multicenter, phase 3b, open-label, randomized, head-to-head trial comparing the efficacy and safety of FM and IV ferric carboxymaltose (FCM) for the treatment of IDA in 179 patients with IBD. [25][26][27] This noninferiority trial included adult patients with confirmed IBD and IDA (Hb = 8.0-11.0 g/dL for women, 8.0-12.0 g/dL for men and either ferritin <30 ng/mL or ferritin <100 ng/mL with TSAT <20%). Patients were randomized to FM 30 mg administered orally twice daily for 12 weeks or IV FCM administered according to manufacturer prescribing information.…”

“…A recent post hoc analysis of the AEGIS H2H study published in abstract format examined the health-related quality of life benefits of FM and IV FCM. 27 The results showed non–statistically significant improvements in health-related quality of life scores (using SF-36) across all domains in both FM and IV FCM treated patients.…”

“…The trials' efficacy results are exhibited in Tables 2 and 3. 5,6,[24][25][26][27] FM efficacy and safety has been evaluated in a total of 473 patients with IDA in phase III trials. The 3 placebocontrolled trials reviewed in the FDA approval of FM for the treatment of IDA evaluated a combined 295 patients with IBD or CKD.…”

Oral Iron for IBD Patients: Lessons Learned at Time of COVID-19 Pandemic

“…Oral iron is a cost-effective option and could temporarily replace intravenous iron in patients with anemia during COVID-19 pandemic [13]. We hypothesize that IBD patients with mild (10 g/dL < Hb < 13 g/dL) and moderate (8 g/dL < Hb < 10 g/dL) anemia may first undergo oral iron supplementation, preferably with ferric maltol, as post-marketing studies confirmed the effective and safe drug profile (Figure 1) [25][26][27]. In contrast, in patients who are unresponsive to oral therapy, or in those with severe anemia (Hb < 8 g/dL), the intravenous formulation should be considered and not delayed.…”

“…In contrast, 50% of the intravenous group patients lost at least one day of work, and 6.7% of them lost four-to-six working days, causing up to 775 € of daily losses per patient [25]. Interestingly, the physical component summary of the short form health survey (SF-36) and the mental component summary (MCS) values were slightly higher (p-value not significant) in patients treated with oral medication, suggesting a greater improvement in quality of life at the end of the study period [26]. In addition, total treatment costs per patient were lower in the oral drug group than in the intravenous arm (302.27 € vs. 489.37 €, respectively) [27].…”