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* = Presenting author

P599 Clinical practice and outcomes of iron isomaltoside administration in anaemic patients with Crohn’s disease and ulcerative colitis

J. Stein*1, H. Hartmann2, A. Walper3

1Crohn’s and Colitis Centre, Gastroenterology, Frankfurt, Germany, 2Centre of Gastroenterology, Herne, Germany, 3MEDICE Arzneimittel Pütter GmbH, Medical Department, Iserlohn, Germany

Background

Anaemia is very common in patients with inflammatory bowel disease (IBD). The recently published ECCO guideline recommends that IBD patients should be regularly assessed for the presence of anaemia. Thus, ECCO stated, that IV iron should be considered as first-line treatment in patients with clinically active disease, with previous intolerance to oral iron, with Hb below 10 g/dL, and in patients who need erythropoiesis-stimulating agents. The objective of this non-interventional study was to prospectively collect data for the treatment routine, efficacy, safety, and tolerability of iron isomaltoside (Monofer®) in anaemic IBD patients.

Methods

The study started in March 2013 (first patient, first visit) and ended in November 2014. Patients included in this non-interventional study suffered from IBD, were at least 18 years old, had anaemia (Hb <12 g/dL in women and Hb < 13g/dL in men) and had given consent to participate in this study. Anaemia and iron status were mainly assessed by Hb, ferritin, transferrin saturation (TSAT), and C-reactive protein. Further analysis was performed on the responder criteria. Response was defined as increase in Hb levels by ≥ 2 g/dL at week 16. All patients were observed over a period of 16 weeks.

Results

Overall, 197 IBD patients were recruited in 37 centres. Data from 180 patients (106 women and 74 men) were available for statistical analysis. Mean patient age was 39 years. Ulcerative colitis was documented in 53% of the patients and 47% were affected by Crohn’s disease. IBD was diagnosed on average 7.6 years before study start. In total, 70 patients were previously treated with oral iron. A previous treatment with IV iron was documented in 65 patients. Anaemia and iron status were mainly assessed by Hb, ferritin, transferrin saturation (TSAT), and C-reactive protein. The patients received a total cumulative dose of 1 304 mg (1 190–1 418 mg) iron isomaltoside during the study. Mean Hb values increased from 10.7 to 13.1 g/dL. An Hb increase of ≥2 g/dL was achieved in 57% of the patients. S-ferritin values increased by 96.4 µg/dL. Mean TSAT improved from 8.1 to 24.0%. Patients with Hb ≤10 g/dL at initial visits were given higher doses than those with Hb values >10 g/dL. Adverse drug reactions were documented for 16 patients. All patients recovered.

Conclusion

The present non-interventional study demonstrates that in routine clinical practice iron deficiency anaemia in IBD patients can be treated effectively with high single doses of IV iron isomaltoside. Administration of iron isomaltoside leads to significant increases in Hb, ferritin, and TSAT values and demonstrated a good safety profile in clinical practice.