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P188. Intravenously administered ferric carboxymaltose and iron sucrose significantly improve quality of life in patients with IBD-associated iron deficiency anaemia

R. Evstatiev1, P. Marteau2, T. Iqbal3, I. Khalif4, M. Gudehus5, C. Gasche1

1Medical University, Vienna, Austria; 2Hôpital Lariboisière, Paris, France; 3University Hospital, Birmingham, United Kingdom; 4State Scientific Center of Coloproctology, Moscow, Russian Federation; 5Vifor Pharma, Glattbrugg, Switzerland

Aim: Inflammatory bowel disease (IBD) is often associated with iron deficiency anaemia (IDA) which affects quality of life (QoL) independent of disease activity. FERGIcor, a randomized, controlled, multicenter study, compared a novel ferric carboxymaltose (FCM) regimen with the currently used iron sucrose (IS) regimen in patients with IBD-associated IDA. The study showed superior Hb-response (Hb-increase ≥2 g/dL; 66% vs. 54%), Hb-normalisation (84% vs. 76%) and sustained superior improvement in transferrin saturation (TSAT) with the FCM regimen. This analysis evaluated the treatment effects on QoL.

Materials and Methods: Patients with IDA (ferritin <100 ng/mL, haemoglobin 7–12 g/dL [female] or 7–13 g/dL [male]) and mild-to-moderate or quiescent IBD (Crohn's disease activity index [CDAI] <220 or colitis activity index [CAI] ≤ 7) received randomised treatment of either FCM, administered in maximum three infusions of 1,000 or 500 mg iron, or IS, given in up to 11 infusions of 200 mg iron. The primary endpoint was Hb-increase ≥2 g/dL at Week 12. Health-related QoL scores were assessed at baseline and Week 12 using the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Health Survey Short Form (SF-36).

Results: Patients in both treatment groups, FCM and IS, achieved similar significant improvements in QoL scores from baseline to Week 12 (p < 0.001) and these changes in QoL scores remained significant upon stratification to responders and non-responders. Analysis of patients of the full analysis set with available IBDQ and SF-36 scores at baseline and after Week 12 (389 and 453, respectively) showed a consistent improvement in the IBDQ as well as SF-36 physical and mental component scores independent of baseline Hb levels (Fig. A). This was even true for baseline Hb levels above 11 g/dL. Notably, patients with Hb-response to i.v. iron experienced significantly higher improvements in the IBDQ total score (p = 0.007) and the SF-36 physical component summary (p = 0.011) (Fig. B). Changes in the SF-36 mental component summary were numerically but not significantly higher among Hb-responders (p = 0.314). Significantly better improvements in IBDQ score and SF-36 physical summary were also observed among patients achieving TSAT of 20–50% compared to non-responders (IBDQ p = 0.036; SF-36 p < 0.0001), whereas ferritin-normalisation was not associated with QoL improvement.

Fig. A. Change in IBDQ from baseline to Week 12.

Fig. B. Change in QoL scores from baseline to Week 12. Hb-response is defined as Hb-increase ≥2 g/dL.

Conclusions: Intravenous iron treatment of patients with IBD-associated IDA significantly improved disease-related as well as overall physical and mental QoL. The significantly better improvements of the IBDQ total score and the SF-36 physical component summary in Hb-responders versus non-responders suggest a treatment-related effect. However, the consistency of QoL improvement independent of baseline Hb-levels argues for the benefit of intravenous iron replacement therapy even in patients with rather high haemoglobin levels.