P451 Safety and efficacy of ferric carboxymaltose (FCM) for the treatment of iron deficiency anaemia in paediatric patients affected by inflammatory bowel disease (pIBD)

Abstract

Background: Iron deficiency anaemia (IDA) is a common complication of pIBD affecting cognitive development and quality of life, and its oral treatment might be is hampered by as poor compliance and efficacy. Intravenous FCM has been shown to be effective and safe for IDA in adult patients, but paediatric studies are limited. Aim: To study the safety and efficacy of FCM in the treatment of IDA in pIBD. Methods: Retrospective review of all pIBD patients with IDA treated with FCM between 2013 and 2018 in two tertiary care paediatric IBD centres. IDA was diagnosed by combining haemoglobin (HB), haematocrit (HCT), mean cell volume (MCV), iron levels, total iron binding capacity (TIBC), transferrin saturation (TSAT), and ferritin. Inflammatory biomarkers (C-reactive protein [CRP] and faecal calprotectin [FC]) were also assessed. Patients received 500-1500 mg of FCM according to body weight. Bloods were repeated 4-6 weeks after each infusion. Patient and disease characteristics are expressed as percentage and mean ± SD. Paired samples t-test was used for statistical analysis, and significance was set at the p < 0.05 level. Results: A total of 213 infusions were administered to 132 pIBD patients with IDA, 70 males (53%), Crohn's disease = 90 (68.2%), ulcerative colitis = 25 (18.9%), inflammatory bowel disease unclassified = 17 (12.9%). Mean age at the first injection was 12.53 years (SD 3.811, range 3-18). Four-six after first FCM injection, a significant improvement was found in HB (107.36 ± 15.899 vs. 122.34 ± SD, p < 0.001), HTC (0.333 ± 0.4 vs. 0.375 ± 0.375; p < 0.001), MCV (75.94 ± 6.8 vs. 80.35 ± 6.82, p < 0.001), iron (7.37 ± 5.03 vs. 11.96 ± 7.21 μmol/l, p < 0.001), TIBC (63.71 ± 18.02 vs. 54 ± 49.80 μmol/l, p < 0.001) TSAT (12.16 ± 8.14 vs. 24.19 ± 13.64%, p < 0.001) and ferritin (64.32 ± 168.45 vs. 215.77 ± 195.43 μg/l, p < 0.001) was shown. No statistical difference was observed pre and post infusion for CRP and FC. Only 3 patients showed an adverse reaction: one developed an anaphylactic reaction, the remaining 2 itch and transient fever. No adverse events were recorded in patients under 6 years old (n = 11). Conclusions: FCM administration is safe and effective for routine management in children with IBD, including those who are under 6 years old.