J Crohns Colitis. 2018 Jun 28;12(7):826-834.doi: 10.1093/ecco-jcc/jjy042.

Jürgen Stein ^1 2, Aysegül Aksan ^1 3, Wolfgang Klemm ⁴, Kerry Nip ⁵, Susanne Weber-Mangal ⁵, Axel Dignass ^1 6

Author information

¹Interdisciplinary Crohn Colitis Centre Rhein-Main, Frankfurt/Main, Germany.

²Department of Gastroenterology and Clinical Nutrition, DGD Clinics Sachsenhausen, Frankfurt/Main, Germany.

³Hacettepe University, Faculty of Health Sciences, Ankara, Turkey.

⁴Gastroenterological Practice, Cottbus, Germany.

⁵Department of Medical Affairs, Vifor Pharma, Munich, Germany.

⁶Department of Gastroenterology, Agaplesion Markus Hospital, Frankfurt/Main, Germany.

Abstract

Introduction: Iron deficiency and iron deficiency anaemia are common complications in inflammatory bowel disease [IBD] patients. Anaemia in IBD is attributable to chronic blood loss and/or impaired iron intake and absorption. International guidelines recommend intravenous iron supplementation in IBD patients, since oral supplements are frequently poorly tolerated and can exacerbate inflammation. Intravenous ferric carboxymaltose [FCM; Ferinject® 50 mg ferric iron[III]/mL suspension] was approved in Europe in 2007 for correction of iron deficiency, and can be administered in single 15-min infusions of up to 1000 mg.

Methods: A prospective non-interventional post-marketing study was performed in 101 centres in Germany to assess the efficacy, tolerability, and convenience of Ferinject® in clinical practice in a large cohort of IBD patients. Primary endpoints were haemoglobin [Hb] normalisation or increase ≥2 g/dL [responders], and normalisation of serum ferritin [s-ferritin] and transferrin saturation. Adverse events [AEs], clinical signs/symptoms, and disease activity indices were also analysed.

Results: In all, 224 subjects (127 Crohn's disease [CD]; 97 ulcerative colitis [UC]) were treated. Mean total iron dose was 1139 mg [range: 100 mg-4800 mg], with 76.7% of doses between 500 mg and 2000 mg; 63.3% of patients responded, and no adverse drug reactions or drug-attributed serious adverse events [SAEs] or deaths occurred. Mean increases of Hb [10.0 to 12.3 g/dL], ferritin [52 μg/L to 103 μg/L], transferrin saturation [TSAT, 15% to 25%], and s-iron [6.1 to 12.4 μmol/L] were significant [p = 0.0001]. Clinical scores and quality of life improved due to the amelioration of anaemia symptoms.

Conclusions: Ferinject®-therapy was proven to be effective and safe in a large cohort of patients with IBD-associated anaemia in routine practice. Rapid, high-dose application is convenient for physicians and reduces patients' time lost from work.