AEGIS-H2H study results published in Inflammatory Bowel Diseases demonstrates long-term effectiveness of ferric maltol compared to intravenous iron.- Shield Therapeutics

Shield Therapeutics plc notes the recent publication in the journal Inflammatory Bowel Diseases of positive long-term results from a AEGIS-H2H study comparing the effectiveness of ferric maltol 30 mg bid (Feraccru/Accrufer) with intravenous (IV) iron (ferric carboxymaltose given according to each centre’s standard practice) over 52 weeks. The primary endpoint was haemoglobin responder rate ( greater than 2 g/dL increase or normalization) at week 12, with a 20% non-inferiority limit in the intent-to-treat and per protocol populations. The open label Phase IIIB study included adults with non-severe active IBD and iron-deficiency anaemia (IDA) and who also had serum ferritin levels below 30 ug/L or ferritin levels below 100 ug/L and transferrin saturation below 20%. The report of this first comparative trial, reflecting real-world conditions in patients with quiescent or mild to moderate IBD and mild to severe IDA, concluded that both oral ferric maltol and standard regimens of IV ferric carboxymaltose achieved clinically meaningful increases in Hb over 12 weeks of treatment, although ferric maltol did not meet the prespecified non-inferiority margin vs IV iron. Over the longer term, ferric maltol showed comparable efficacy in maintaining Hb improvements and increasing ferritin up to week 52, consistent with IV iron. The safety profile of each treatment was consistent with previous studies. See-"Long-Term Effectiveness of Oral Ferric Maltol vs Intravenous Ferric Carboxymaltose for the Treatment of Iron-Deficiency Anemia in Patients With Inflammatory Bowel Disease: A Randomized Controlled Noninferiority Trial."- Stefanie Howaldt, MD, Eugeni Domènech, MD, PhD, on behalf of the AEGIS Trialists- Inflammatory Bowel Diseases, izab073, https://doi.org/10.1093/ibd/izab073 Published: 14 May 2021. .