Safety and efficacy of intravenous iron isomaltoside for correction of anaemia in patients with inflammatory bowel disease in everyday clinical practice

Abstract

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.

Keywords:

• Ferric derisomaltose
• IBD
• iron deficiency anaemia
• iron isomaltoside

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Acknowledgements

MEDICE Arzneimittel Pütter GmbH, Germany, sponsored this study and supported the development of the study design. An independent clinical research organisation (INPADS GmbH, Germany) conducted the study and performed the statistical analyses. The authors interpreted the results and made the decision for submission independently. The authors gratefully acknowledge all the investigators and study personal for their contribution to the study and Eva-Maria Damsgaard Nielsen for provided medical writing assistance. Eva-Maria Damsgaard Nielsen is employed by Pharmacosmos A/S. In addition, the authors would like to thank Janet Collins (Interdisciplinary Crohn-Colitis Centre Rhein-Main, Frankfurt) for final corrections and proofreading.

Disclosure statement

The investigators/institutions received a fee per patient. JS and AD have received speaker and advisory honoraria from MEDICE and Pharmacosmos A/S. However, the authors stress that the present text reflects solely their independent views. WK, AA and KF have no conflicts of interests to declare. AW is the employee of MEDICE Arzneimittel Pütter GmbH, Germany.

Additional information

Funding

This study was funded by MEDICE Arzneimittel Pütter GmbH & Co.