GHAPP_site_logo-white.png
Sign up for Updates
  • Facebook - White Circle
  • Twitter - White Circle
  • Instagram - White Circle
  • LinkedIn - White Circle

© 2019 Gastroenterology & Hepatology Advanced Practice Providers

Safety and Efficacy of Ferric Carboxymaltose in the Treatment of Iron Deficiency Anaemia in Patients with Inflammatory Bowel Disease, in Routine Daily Practice

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 irondose 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.

Authors

Stein J1,2, Aksan A1,3, Klemm W4, Nip K5, Weber-Mangal S5, Dignass A1,6.

 

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

Author Information

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

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

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

  4. Gastroenterological Practice, Cottbus, Germany.

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

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