P481 A Scandinavian prospective observational study of iron isomaltoside 1000 treatment: Clinical practice and outcomes in iron deficiency anaemia in patients with IBD
S.O. Frigstad*1, T. Rannem2, P.M. Hellstrom3, P. Hammarlund4, O. Bonderup5
1Vestre Viken Hospital Trust, Baerum Hospital Medical Division, Drammen, Norway, 2Nordsjaellands Hospital, Department of gastroenterology, Hilleroed, Denmark, 3Uppsala University Hospital, Department of Medical Sciences, Uppsala, Sweden, 4Angelholms Hospital, Medical Division, Angelholm, Sweden, 5Regional Hospital of Silkeborg, Diagnostisk Center, Silkeborg, Denmark
Iron deficiency is a frequent complication in inflammatory bowel diseases (IBD) with negative effects on quality of life. Appropriate iron substitution is crucial. The objective of this study was to prospectively collect data for treatment routine, efficacy and safety of iron isomaltoside 1000 in IBD patients.
This observational study included 149 IBD patients, 82 with Crohn's disease (CD) and 67 with ulcerative colitis (UC), treated with iron isomaltoside 1000 at 10 sites in Denmark, Norway and Sweden. Data for iron treatment, blood tests and adverse drug reactions (ADRs) were recorded from August 2013 to October 2014.
Of 149 patients 69 were male and 80 female with a mean age of 41.7 (17-75) years and a mean body weight of 74.1 (45-137) kg. Four percent had received oral iron, and no patients had blood transfusions or erythropoietin before treatment with iron isomaltoside 1000. Two patients did not receive the full prescribed dose and were excluded from the efficacy analysis. Mean baseline levels of haemoglobin (Hb), ferritin and transferrin saturation (TSAT) were 11.6 g/dL, 24.2 micrograms/L and 9.7 %, respectively. The treatment resulted in a mean increase from baseline to the first blood test follow-up of 1.4 g/dL for Hb, 113 micrograms/L for ferritin and 8.4 % for TSAT (p < 0.001 for all three parameters) during a mean time of 7.2 weeks following treatment. There were no significant differences between the CD and UC groups. The mean Hb increase for patients with baseline Hb below 10 g/dL was 3.2 g/dL and for all patients with anaemia at baseline 1.7 g/dL (p < 0.001). The mean administered iron dose in the study was 1010 mg. The mean dose that would have been needed for full iron correction was higher than the mean dose administered, 1363 mg using the simplified dosing table and 1100 mg using the Ganzoni formula, respectively. A total of 95 % were treated at one single visit. Ferritin of 100 micrograms/L was reached in only 49 % of patients and 27 % were still anaemic after treatment. Six (4 %) ADRs were reported. Three (2 %) were described as acute infusion reactions. The other events were fever, headache, nausea and skin reactions. All patients with ADRs had an uneventful recovery.
This study demonstrates good efficacy and tolerability of iron isomaltoside 1000 in IBD patients treated for iron deficiency. Although the patients had significant increases in Hb, more than one in four patients was still anaemic after iron treatment. Combined with the finding of iron doses given being lower than the estimated iron need, this suggests that doses of iron routinely given in clinical practice are lower than needed for full iron correction.