Nicholas Carman1,2, Richard Muir3, Peter Lewindon1,4. 1. Department of Gastroenterology, Queensland Children's Hospital, South Brisbane, Queensland, Australia. 2. Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Canada. 3. Department of Gastroenterology, The Wesley Hospital, Brisbane, Queensland, Australia. 4. Queensland Children's Medical Research Institute, University of Queensland, Brisbane, Queensland, Australia.
Abstract
BACKGROUND: Iron deficiency (ID) with or without anemia is a common complication of pediatric inflammatory bowel disease (IBD), causing significant morbidity. Despite this, ID remains prevalent and undertreated, related in part to questions surrounding optimal formulation and route of administration. Ferric carboxymaltose (FCM) is a recent formulation of intravenous iron, allowing higher doses and rapid infusion times. This study aims to demonstrate the efficacy and safety of FCM in paediatric patients with IBD, and explore the differences between patients with active and quiescent disease. METHODS: Paediatric patients 6-18 years with IBD with iron deficiency (ID) or iron deficiency anemia (IDA) were treated prospectively with FCM at the Queensland Children's Hospital in Brisbane. Patients received FCM as a single dose of 15 mg/kg up to 1,000 mg over 15-20 min. Biochemical parameters measured prior to and approximately 8 weeks after the infusion were: hemoglobin (Hb), mean corpuscular volume (MCV), ferritin, and transferrin saturation (TS). C-reactive protein (CRP) was measured as a marker of co-existing inflammation. Resolution of anemia or ID was assessed following treatment, with adverse events captured. RESULTS: A total of 101 patients received infusions of FCM during the study period and were analysed, median age 14 (IQR 14-16) years. A total of 44% of patients underwent treatment for IDA, while 56% were for ID without anemia. Following FCM infusion, 64% of patients with IDA had resolution of anemia, with 81% showing resolution for ID without anemia. Elevation of CRP throughout the study period had no influence on resolution of IDA with FCM (P=0.68), but in patients with ID, patients with quiescent disease activity were more likely to have resolution of ID [odds ratios (ORs) 5.1; P=0.03]. CONCLUSIONS: Rapid, high dose FCM in children aged 6 and over is safe, well tolerated and efficacious for correction of ID. Replenishing iron in IBD is important and FCM improves our ability to meet this need.
BACKGROUND: Iron deficiency (ID) with or without anemia is a common complication of pediatric inflammatory bowel disease (IBD), causing significant morbidity. Despite this, ID remains prevalent and undertreated, related in part to questions surrounding optimal formulation and route of administration. Ferric carboxymaltose (FCM) is a recent formulation of intravenous iron, allowing higher doses and rapid infusion times. This study aims to demonstrate the efficacy and safety of FCM in paediatric patients with IBD, and explore the differences between patients with active and quiescent disease. METHODS: Paediatric patients 6-18 years with IBD with iron deficiency (ID) or iron deficiency anemia (IDA) were treated prospectively with FCM at the Queensland Children's Hospital in Brisbane. Patients received FCM as a single dose of 15 mg/kg up to 1,000 mg over 15-20 min. Biochemical parameters measured prior to and approximately 8 weeks after the infusion were: hemoglobin (Hb), mean corpuscular volume (MCV), ferritin, and transferrin saturation (TS). C-reactive protein (CRP) was measured as a marker of co-existing inflammation. Resolution of anemia or ID was assessed following treatment, with adverse events captured. RESULTS: A total of 101 patients received infusions of FCM during the study period and were analysed, median age 14 (IQR 14-16) years. A total of 44% of patients underwent treatment for IDA, while 56% were for ID without anemia. Following FCM infusion, 64% of patients with IDA had resolution of anemia, with 81% showing resolution for ID without anemia. Elevation of CRP throughout the study period had no influence on resolution of IDA with FCM (P=0.68), but in patients with ID, patients with quiescent disease activity were more likely to have resolution of ID [odds ratios (ORs) 5.1; P=0.03]. CONCLUSIONS: Rapid, high dose FCM in children aged 6 and over is safe, well tolerated and efficacious for correction of ID. Replenishing iron in IBD is important and FCM improves our ability to meet this need.
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