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* = Presenting author

P339 High dose intravenous iron isomaltoside 1000 in subjects with inflammatory bowel disease - the PROMISE trial

J.F. Dahlerup*1, S. Lindgren2

1Aarhus University Hospital, Department of Hepatology and Gastroenterology , Aarhus, Denmark, 2Lund University, University Hospital MAS, Department of gastroenterology, Malmö, Sweden

Background

Patients with inflammatory bowel disease (IBD) often suffer from iron deficiency anaemia (IDA), and have a high annual iron need which can be difficult to replace orally. Also, due to the IBD disease as such oral iron is most often not suitable for these patients. An intravenous (IV) iron which is possible to administer as a high dose infusion in a single visit would offer the best pharmacoeconomic profile and optimal convenience for patients. The present trial evaluates high single and total doses of iron isomaltoside 1000 (Monofer®) in patients with IBD.

Treatment GroupHaemoglobin (Hb)Body Weight < 70 kgBody Weight &ge; 70 kgStudy Duration
AWomen: 10 &le; Hb < 12 g/dL and men: 11 &le; Hb < 13 g/dL1,500 mg Monofer2,000 mg Monofer*8 weeks
BWomen: Hb < 10 g/dL and men: Hb < 11 g/dL2,500 mg Monofer*3,000 mg Monofer*16 weeks

Methods

In this prospective, open-label, multi-centre GCP regulated safety trial iron isomaltoside 1000 was administered to subjects with IBD and IDA. The subjects were divided into two treatment groups:

*Dose given in two visits - 1500 mg at the first visit, remainder at the second visit. All doses were infused over approximately 15 min. Outcome measures were safety parameters and Hb measurements.

Results

21 subjects were enrolled.

Hb increased from a mean of 10.8 (±1.0 SD) g/dL at baseline to 13.3 (±0.6 SD) g/dL at week 8 in group A (p < 0.0001, n = 11) and from 8.5 (±1.3 SD) g/dL to 11.6 (±3.5 SD) g/dL at week 16 in group B (p = 0.0755, n = 5).

No serious adverse drug reactions (ADRs) were observed. 9 mild to moderate ADRs were observed in 4 subjects (1 subject had 4 events (feverish, vomiting, constipation, palpitations and dyspnoea), 1 subject had 2 events of eye allergy, 1 subject had 1 event of abdominal pain, and 1 subject had 2 events of chest pain with dyspepsia) and they were all reported as recovered.

Phosphate was (mean±SD) 3.7 (±0.4) mg/dL at baseline and 3.6 (±0.5) at week 8 in group A and 3.9 (±0.6) mg/dL at baseline to 3.8 (±0.3) mg/dL at week 16 in group B. No ADRs of hypophosphatemia were reported.

Conclusion

Rapid infusions of high dose iron isomaltoside 1000 administered as single doses up to 1,500 mg and cumulative doses up to 3,000 mg were completed without safety concerns and were efficacious in increasing Hb in IBD patients. This treatment algorithm represents are promising alternative to current routines.

The trial was sponsored by Pharmacosmos A/S.