OBJECTIVES : Iron deficiency without anemia (ID-noA) in patients with Inflammatory Bowel Disease (IBD) might impose important clinical implications and the role of parenteral treatments requires further research. This study aims to assess the benefit-risk profile of ferric carboxymaltose (FCM) in IBD patients with ID-noA, including changes in their reported health-related quality of life (HRQoL).

METHODS : An observational, multicentre, prospective research was conducted including consecutive IBD patients (ulcerative colitis and Crohn disease) with no active or mild disease activity suffering from ID-noA and undergoing a treatment with ferric carboxymaltose according to routine clinical practice (n=98). Variables were measured at baseline and after 4 weeks from treatment: blood tests (i.e., ferritin, serum iron, transferrin saturation index [TSAT]), patient´s self-reported ID-symptoms and HRQOL [Short Form-12 (Physical Component Summary and Mental Component Summary) and EQ-5D]. Differences from baseline were tested with non-parametric tests (Wilcoxon signed-rank and McNemar’s test).

RESULTS : A clear benefit in clinical parameters was observed (i.e., % of patients with TSAT<16% dropped from 73.75% to 8.75%, p<0.001). Self-reported symptoms improved four weeks after treatment. Average increase of 7.5 points in VAS score (p<0.01), 0.102 points in EQ-5D index score (p<0.001), 2.9 points in the PCS (p<0.01) and 7.3 points in the MCS (p<0.001). Overall, all differences were statistically significant. The same analysis was performed for separate cohorts of patients with Crohn's disease and ulcerative colitis, producing comparable results.

CONCLUSIONS : Treatment with FCM for ID-noA IBD patients was associated with a high effectiveness due to a prompt response of iron parameters with meaningful clinical improvements. FCM can very quickly improve reported symptoms and HRQoL.