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

Objectives and Study: Iron deficiency anaemia (IDA) is common in pIBD affecting cognitive development and quality of life, and its oral treatment is hampered by poor compliance and efficacy. Intravenous FCM has been shown to be effective and safe for IDA in adult patients, but paediatric studies are limited. We aimed to study the safety and efficacy of FCM in the treatment of IDA in pIBD. Method(s): 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, and ferritin. Inflammatory biomarkers (Creactive protein [CRP], faecal calprotectin [FC]) and phosphate levels were also assessed. Patients received 15 mg/kg of FCM (total weekly dose max 500 or 1500 mg according to body weight 35 kg respectively). Bloods were repeated 4-6 weeks and 12 weeks after each infusion. Concomitant medications, changes in treatment (dose escalation/shift to different drugs), disease activity measured by Physician Global Assessment (PGA) and PUCAI or PCDAI were recorded at same time points. Result(s): A total of 203 infusions were administered to 128 pIBD patients with IDA, 68 males ( 53.1 % %), Crohn's disease = 88 (68.7%) , ulcerative colitis = 23 (17.97%) , inflammatory bowel disease unclassified = 17 (13,3%). Overall, a total of 186 infusions were analysed for sustained efficacy as 17 were excluded because of an additional infusion needed within 12 weeks from the previous one. Mean age at the first injection was 12.46 years (SD 3.63, range 3-18). The mean number of weeks between infusions for patients requiring multiple infusions (n=44) was 34,74 (SD: 34,20). Relevant changes in concomitant medications were needed at the time of 101/186 infusions (54.3%). Four-six weeks after FCM injection, a significant improvement was found in HB (106.36 +/-16.518 vs 122.73 +/- 12.835, g/L p< 0.001), MCV (74.424 +/- 10.123 vs 80.602 fL+/- 22.244, p< 0.001), iron (6.060 +/- 3.982 vs 11.737 +/- 6.829 umol/l, p< 0.001), ferritin (67.29 +/- 109.467 vs 218.15 +/- 212.387 ug/L, p< 001) and ESR (32.92 +/- 26.82 vs 25.99 +/- 22.98 mm/hr, p< 0.05). Furthermore, 12 weeks after the FCM infusion a significant statistical difference compared to baseline was found in the following parameters: HB (107.32 +/- 15.331 vs 123.74 g/L +/- 14.646, p< 0.001), MCV (74.851 +/- 10.224 fL, p< 0.001), iron (6.527 +/- 3.959 vs 10.463 +/- 6.4528 umol/L, p< 0.001), ferritin (80.27 +/- 146.183 vs 137.07 +/- 146.466, ug/L p< 0.05). There was no statistically significant difference for CRP and FC at week 0, 4-6 and 12 (repeated measures). The interaction effect of the disease phenotype and changes in treatment on the outcome (level of Hb at week 4-6 and 12) was not statistically significant.Only 3 patients reported an adverse reaction; one developed an anaphylactic reaction, the remaining 2 pruritus and transient fever. Among the 25 patients with low serum phosphate, only 2 had the severe hypophosphatemia (phosphate