CP-060 Effectiveness and safety of ferric carboxymaltose treatment in patients with inflammatory bowel diseases

BackgroundPatients with inflammatory bowel disease (IBD) are at risk for iron deficiency. Absorption of orally given iron may be impaired by intestinal inflammation, and treatment with oral iron may aggravate intestinal inflammation. The treatment of iron deficiency anaemia with IBD is a particular challenge and often insufficient.PurposeTo describe the effectiveness and safety of intravenous ferric carboxymaltose (FCM) in IBD adult patients.Material and methodsObservational, retrospective study in two general hospitals. IBD adult patients who had received at least one dose of FCM from August 2013 to August 2015 for up to 3 months were analysed. Data collection from clinical records: age, gender, IBD (Crohn’s disease (CD) or ulcerative colitis (UC)), FCM dosage, biological drug treatment, haemoglobin (g/dL), haematocrit (%), mean corpuscular Hb concentration (MCHC g/dL), serum ferritine level (SFL ng/mL), all pre-FCM and post-FCM infusion. The safety profile was evaluated on the basis of the proportion of patients who experienced any adverse drug reaction (ADR). Statistical analysis was powered by SPSS 15.0 (paired t test).ResultsIn total, 46 IBD patients were treated for concomitant iron deficiency anaemia: mean age 49.3 ± 6.6 years, 22 (47.8%) women, 28 with CD (60.9%) and 18 with UC (39.1%). The mean cumulative dose was 978 ± 103.2 mg of iron; without concomitant biological drug 27 (58.7%) patients, 14 (30.4%) with infliximab, 4 (8.7%) with adalimumab and 1 (2.2%) with golimumab. Correction of iron deficiency anaemia was observed with improved mean Hb levels from 11.7 ± 1.4 g/dL at baseline to 13.6 ± 0.9 g/dL within 12 weeks (p < 0.001), mean haematocrit 36.1 ± 4.7% vs 41.0 ± 3.1% (p < 0.001), mean MCHC 27.9 ± 3.2 g/dL vs 30.2 ± 2.4 g/dL (p < 0.001), mean SFL 49.9 ± 84.5 ng/mL vs 205.2 ± 194.4 ng/mL (p < 0.001), respectively. Six (13.1%) subjects reported mild ADRs related to FCM; 4 (8.7%) of these were considered to be potentially related to long duration of administration and to a high volume of saline solution for dilution.ConclusionOverall FCM was well tolerated in this population and appeared to be effective in correcting iron deficiency anaemia. We cannot exclude the fact that correction of iron deficiency anaemia is in some part due to the treatment of the underlying disease and not related to the iron supplementation alone.No conflict of interest.