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DOP079. Correcting iron deficiency anaemia in IBD: A pivotal phase 3 study of a novel oral ferric iron

C. Gasche1, Z. Tulassay2, T. Ahmad3, A. Stallmach4, for the AEGIS Study Group, 1Medical University of Vienna, Vienna, Austria, 2Semmelweis University, Budapest, Hungary, 3Royal Devon and Exeter Hospital, Exeter, United Kingdom, 4Friedrich Schiller University Jena, Jena, Germany

Background

Iron deficiency anaemia (IDA) is common in inflammatory bowel disease (IBD). Traditional oral ferrous (Fe2+) salts, are often poorly tolerated and may adversely affect IBD. Ferric (Fe3+) iron salts are well tolerated but poorly absorbed due to insoluble chelate formation in the gut. ST10 is a novel Fe3+ iron that remains in an absorbable state.

The aim of this study was to demonstrate the efficacy of oral ST10 over placebo in the treatment of IDA in subjects with quiescent IBD who have failed to respond to, or been intolerant to, oral ferrous salts. The primary endpoint was change in Hb from baseline to Week 12. Secondary endpoints included safety, disease activity and quality of life [Clintrials.Gov: NCT01340872/01352221].

Methods

Double blind randomised controlled trial of 120 IBD subjects with IDA (Hb 9.5–12.0 g/dL female, 9.5–13.0 g/dL male; and ferritin <30 µg/L). Subjects were randomised to receive oral 30 mg ST10 twice a day for 12 weeks or identical placebo. At the study end all available subjects were enrolled in a 52 week open label study. The study was approved by the relevant Ethics Committee and informed consent was obtained from all subjects.

Results

128 subjects were randomised. Baseline Hb, age and gender were comparable in both groups. The pre-specified analysis plan included the first 120 subjects randomised (60 ST10, 60 Placebo; 67 CD, 53 UC). 101 (87% ST10, 82% Placebo) completed at least 12 weeks treatment. Mean Hb improved by 2.3 g/dL from 10.9 to 13.2 g/dL in the ST10 group and remained at 11.1 g/dL in the Placebo group. Difference between estimated means was 1.0 g/dL at 4 weeks, 1.8 g/dL at 8 weeks and 2.2 g/dL at 12 weeks, [p < 0.0001 for all 3 analyses, ANCOVA]. Hb increased to normal values in 65% of ST10 group and 10% of Placebo subjects.

Adverse events (AEs) were recorded in 58% of ST10 and 72% of the Placebo subjects. Gastrointestinal AEs were observed in 38% and 40%, respectively. In the ST10 group the most common AEs were abdominal pain (10%), diarrhoea (7%), constipation (6%) and nasopharyngitis (4%). Study medication discontinuation due to AEs in 8 ST10 and 5 Placebo subjects. There was 1 serious AE in the ST10 and 2 in the Placebo group. AE data and IBD activity scores suggested that ST10 did not increase IBD symptoms.

Conclusion

At 12 weeks of treatment ST10 gave a highly statistically significant, and clinically relevant rise in Hb of 2.2 g/dL and increase of 1.0 g/dL by 4 weeks. Over the study period ST10 was well-tolerated (87% completing 12 weeks of treatment) and did not exacerbate IBD symptoms.

ST10 may provide an alternative to IV iron in anaemic patients intolerant or unsuitable to be treated with existing oral iron therapies.