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P701 The comparative safety of different intravenous iron preparations in inflammatory bowel disease: a systematic review and network meta-analysis

A. Aksan*1,2, H. Işık2, K. Farrag1,3, A. Dignass4, J. Stein1,3

1Interdisciplinary Crohn Colitis Centre Rhein-Main, Frankfurt/Main, Germany, 2Hacettepe University, Ankara, Turkey, 3DGD Clinics Sachsenhausen, Frankfurt/Main, Germany, 4Agaplesion Markuskrankenhaus, Frankfurt/Main, Germany

Background

Anaemia occurs with an estimated prevalence of ca. 74% in patients with IBD, causing increased morbidity and hospitalisation rates and impacting quality of life. Oral iron compounds cause gastrointestinal side effects and therapy adherence is poor. Modern intravenous (IV) iron compounds have been shown to be safe and effective in IBD. ECCO IBD guidelines recommend IV iron therapy for severe anaemia and in patients intolerant or unresponsive to oral iron. We compared the tolerability of different IV iron therapies for IDA in IBD [ferric carboxymaltose (FCM), ferumoxytol (FOX), iron sucrose (IS), iron isomaltoside (ISM) and iron dextran (IDX)] in a systematic review and network meta-analysis (NMA).

Methods

A literature search was performed up to August 2018 in PUBMED, SCOPUS, Web of Science and the Cochrane Library. Primary outcome measure was the pooled total of drug-related AEs and SAEs as % of safety population. Secondary outcome was identification of the most common AEs. Bayesian NMA was performed to calculate the tolerability of each iron therapy relative to all comparators. Results were presented as OR in relation to AE rate.

Results

2730 papers were found. After duplication removal and detailed review, 24 eligible studies were included: 4 RCTs (NMA) and 20 others (systematic review only). No eligible studies for FOX and no RCTs for IDX were found. Bayesian NMA was performed on 4 eligible RCTs (n = 1052). No statistically significant difference was found between different IV iron products or oral iron (vs. oral iron: OR = 0.87, 95% CrI [0.43; 1.7] for FCM, OR = 0.80, 95% CrI [0.36; 1.8] for IS, OR = 1.5, 95% CrI [0.64; 3.7] for ISM). The systematic review (n = 2619) showed overall AE rates of 83/1028 (8.1%) for FCM, 78/481 (16.2%) for IS, 89/475 (18.7%) for ISM and 10/83 (12%) for IDX. Pooled rates of drug-related SAEs were 0.1%, 2.2%, 0.0%, 1.1%, for FCM, IS, IDX and ISM, respectively. For oral iron, AE/SAE rates were 22.6%/1.4%.

Conclusion

While the systematic review indicates FCM to be associated with fewer AEs, as also suggested most recently by a Dutch trial,1 statistical significance was not reached due to sparsity of data from RCTs. Although hypophosphatemia is suspected to be associated with IV iron administration, especially FCM, it was temporary and asymptomatic, if reported. No severe hypophosphatemia-related bone manifestations occurred in the RCTs or other prospective studies. Further comprehensive trials are needed for head-to-head comparison of the safety of different IV iron substances.

Reference

1 Mulder et al. Eur J Clin Phamacol 2018.