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Aims: Iron deficiency anaemia (IDA) is common in patients with inflammatory bowel disease (IBD), who are often treated with intravenous iron. This observational study aimed to investigate the effectiveness and safety of iron isomaltoside in routine practical care of IDA in IBD patients. Methods: The study included 197 IBD patients designated for treatment with iron isomaltoside. Treatment was administered according to routine practice. Data were recorded at baseline and after approximately 4, 8, and 16 weeks. Efficacy data included haemoglobin (Hb) levels and haematinics, while safety data included adverse drug reactions and safety laboratory variables. Results: Patients received a mean (range) cumulative dose of 1304 (100-3500) mg iron isomaltoside. Hb increased from 10.7(±1.6) g/dL at baseline to 13.1(±1.5) g/dL at the final visit. In addition, serum iron, ferritin and transferrin saturation increased and soluble transferrin receptor decreased. Calprotectin decreased, as did IBD symptom scores, Harvey-Bradshaw Index (Crohn’s disease) and partial Mayo score (Ulcerative colitis). About 8% of patients reported transient adverse reactions, most commonly skin reactions, nausea and vomiting, and 2% SAEs, most frequently tachycardia. Conclusion: Iron isomaltoside was demonstrated to be effective and had a good safety profile in IBD patients in everyday clinical practice in Germany. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]