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P200. Significant benefit of ferric carboxymaltose in IBD-associated iron deficiency anaemia is independent of patient baseline characteristics

T. Iqbal1, R. Evstatiev2, K. Chopey3, J. Harjunpää4, C. Gasche2

1University Hospital, Birmingham, United Kingdom; 2Medical University Vienna, Vienna, Austria; 3National University, Uzhgorod, Ukraine; 4Vifor Pharma, Glattbrugg, Switzerland

Aim: Iron deficiency anaemia (IDA) is a frequent complication of inflammatory bowel disease (IBD); ideally managed with intravenous iron. However, patients with IBD are heterogeneous in their baseline characteristics such as Hb levels, iron status, IBD-specific medications, and disease characteristics. FERGIcor is the largest study to date addressing IDA in IBD, and thus we analysed the data to evaluate whether the superior efficacy of the ferric carboxymaltose (FCM) regimen over the iron sucrose (IS) regimen or the significant benefit of intravenous iron are predicted by baseline characteristics.

Materials and Methods: FERGIcor was a randomised, controlled, multicentre study comparing a standardised FCM dose-regimen with the Ganzoni-calculated IS regimen in patients with IBD-associated IDA (Crohn's disease activity index [CDAI] <220 or colitis activity index [CAI] ≤7, ferritin <100 ng/mL, haemoglobin [Hb] 7–12 g/dL [female] or 7–13 g/dL [male]). FCM was administered in maximum three infusions of 1,000 or 500 mg iron as per predefined ranges of body weight and Hb levels. IS was given in up to 11 infusions of 200 mg iron. The primary endpoint was Hb-response (increase ≥2 g/dL) at Week 12. The statistical significance of baseline characteristics as predictors of response was assessed with logistic regression.

Results: Hb-response at Week 12 was achieved in 66.1% of patients in the FCM group and 54.1% in the IS group (OR 1.65, 95% CI 1.10–2.47; p = 0.016) of the per-protocol population (n = 399). Significance of the treatment benefit FCM vs. IS was not affected by adjustment for baseline Hb (<10 g/dL; OR 1.86, CI 1.18–2.92), TSAT (<20%; OR 1.65, CI 1.07–2.55), ferritin (<30 ng/mL; OR 1.57, CI 1.02–2.41), transferrin (≥3 g/L; OR 1.67, CI 1.10–2.53), use of anti-TNF treatments (OR 1.65, CI 1.10–2.47), CRP (OR 1.56, CI 1.01–2.39) or IBD remission status (OR 1.64, CI 1.09–2.47). Substantial Hb-response rates to intravenous iron were observed across all baseline Hb categories (Figure). The treatment effect of intravenous iron with either of the preparations was more pronounced in patients with advanced iron deficiency (TSAT < 20%, OR 5.54, CI 2.68–11.42; ferritin <30 ng/mL, OR 5.73, CI 3.04–10.79; transferrin ≥3 g/L, OR 1.55, CI 1.02–2.34) whereas use of anti-TNF treatments (OR 0.95, CI 0.48–1.89), high CRP (OR 0.68, CI 0.42–1.11) or remission status (OR 0.91, CI 0.59–1.42) were not predictive of response.

Conclusions: Intravenous iron effectively corrects IBD-associated IDA independent of remission or inflammatory status. Although markers of advanced iron deficiency are predictive of response to iron therapy, even patients with rather high baseline Hb levels can benefit. Baseline levels of Hb and iron parameters, the status of IBD and inflammation or the use of concomitant IBD treatments did not affect the superiority of the FCM regimen over the IS regimen.

Figure: Hb-responders (Hb increase ≥2 g/dL from baseline to Week 12).