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P157. Improvement in hematological status and symptoms in IBD patients using ferric carboxymaltose (Ferinject®): A German multicenter non-interventional study

P157. Improvement in hematological status and symptoms in IBD patients using ferric carboxymaltose (Ferinject®): A German multicenter non-interventional study

J. Stein1,2, A. Dignass3,2, S. Weber-Mangal4, F. Hartmann5,2

1St. Elisabethen-Krankenhaus, Frankfurt, Germany; 2Crohn Colitis Centre Rhein Main, Frankfurt, Germany; 3Markuskrankenhaus, Frankfurt, Germany; 4Vifor Pharma Germany GmbH, Munich, Germany; 5St. Marienkrankenhaus, Frankfurt, Germany

Aims: Anemia is a frequent complication in inflammatory bowel disease (IBD), affects quality of life, and is a comorbid condition in other diseases. Recent guidelines suggest that iron supplementation should be administered intravenously in IBD (Gasche et al. IBD; 2007). Intravenous iron sucrose proved as a safe and effective treatment of anemia in IBD. Whereas iron sucrose doses should not exceed 500 mg/infusion/wk, the novel ferric carboxymaltose (FCM, Ferinject) can be applied at single doses of up to 1,000 mg. This non-interventional study gives insight into the current status of anemia treatment in IBD patients by evaluating the efficacy and tolerance of intravenous iron, and considering both hematological and quality-of-life outcome.

Methods: Up to April 2010, 135 IBD patients (80 Crohn's disease, 55 ulcerative colitis), mean age 38 (18–83) years, were investigated at 40 centers in Germany. Subjects had an Hb value <12 g/dl (women) or <13 g/dl (men), and a refractory anemia to previous treatments. For each patient, iron requirement was calculated according to Ganzoni's formula. Clinical assessment, adverse events, hematological parameters, and other routine laboratory tests, including serum ferritin, transferrin saturation (TSAT), and CRP, were monitored at baseline and on week 12.

Results: 8 months prior to inclusion, 44.4% of patients had received anti-anemic treatment; 21.5% received oral iron alone, 12.6% i.v. iron alone, 8.9% oral + i.v. iron and 3 patients were transfused. At baseline, the mean (range) Hb value was 10.1 g/dL (6.6–11.9). On average the patients received 1103 mg FCM. The laboratory data are shown in Table 1. At baseline 94.7% of the patients were anemic. After treatment 32.3% of patients had improved and 64.7% had normal Hb levels. Ferritin levels and the TSAT also significantly increased. The following percentages of patients reported improvements between baseline and week 12: lack of concentration: 84.0%, dyspnoe: 82.4%, headache: 80.0% and fatigue: 79.2%. No serious or unexpected AEs were reported.

Conclusions: Total intravenous iron replacement with ferric carboxymaltose is an easy, safe, and very effective alternative method for treating iron deficiency anemia in IBD. Anemia correction with iron treatment was also associated with a relevant improvement in the patients' quality of life.

Table 1
 UnitsMean
  BaselineW12Delta
Hbg/dl10.112.7+2.6
Ferritinμg/l36.2100.3+64.1
TSAT%13.021.7+8.7