Safety and Efficacy of Ferric Carboxymaltose in the Treatment of Iron Deficiency Anaemia in Patients with Inflammatory Bowel Disease, in Routine Daily Practice

Stein, Jürgen M.; Aksan, A; Klemm, W; Kerry, Nip; Weber-Mangal, S; Dignaß, Axel

doi:10.1093/ecco-jcc/jjy042

Cited by 12 publications

(18 citation statements)

References 30 publications

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“…increase in Hb levels in patients with lower baseline Hb values [8], our data did not confirm this finding. In our study, patients who did not respond to the first infusion of FCM were more likely to need additional infusions at the end of the follow-up, therefore the response to a single FCM infusion could help the clinician decide whether to complete the iron load or wait and do it if clinically needed.…”

Section: Discussioncontrasting

confidence: 91%

“…Dextran-based iron formulations carried a potential risk for dextran-induced anaphylactic reactions [7], therefore newer intravenous formulations, such as ferric carboxymaltose (FCM) were developed, and are currently routinely used in IBD centers to treat IDA. Stein et al [8] reported that 63% of patients with IBD treated with FCM had normalization of Hb values or an increase of at least 2 g/dL after 12-14 weeks from baseline. The FERGIcor trial was the first trial to compare FCM and iron sucrose in an IBD cohort, and it showed a better response and gain in hemoglobin levels in patients treated with FCM [9].…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness and safety of an on-demand ferric carboxymaltose infusion strategy in patients with inflammatory bowel disease: a real world experience

Grova¹,

Crispino²,

Maida³

et al. 2022

European Journal of Gastroenterology &Amp; Hepatology

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Background We evaluated an on-demand ferric carboxymaltose (FCM) infusion strategy in inflammatory bowel disease (IBD) patients with iron deficiency anemia (IDA). Aims The primary outcome was the response rate to single or multiple FCM infusions after 12 months. Secondary outcomes were the response rate to a single FCM infusion after 3 months and the FCM safety profile. Methods We retrospectively included 185 IBD patients who received at least one FCM infusion of 500 mg, between 2015 and 2018. FCM was administered to patients with Hb ≤10 g/dL and hypoferritinemia and repeated according to the physician’s assessment. Complete response (CR) was defined as Hb ≥12 g/dL (≥13 g/dL for men) or Hb increase ≥2 g/dL. Partial response (PR) was defined as an Hb increase between 1 and 2 g/dL. A univariate analysis was performed at 3 and 12 months. Results After 12 months, the response rate was 75.1% (CR, 48.6%; PR, 26.4%; mean number of FCM infusions, 1.7 ± 1.1). In total 169/185 patients received a single FCM infusion during the first 3 months and 79.2% achieved response (CR, 56.8%; PR, 22.4%). At univariate analysis, no variable was associated with response. No adverse events were reported. Conclusions An on-demand strategy was effective and well-tolerated in treating IDA in IBD patients.

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Section: Discussioncontrasting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Effectiveness and safety of an on-demand ferric carboxymaltose infusion strategy in patients with inflammatory bowel disease: a real world experience

Grova¹,

Crispino²,

Maida³

et al. 2022

European Journal of Gastroenterology &Amp; Hepatology

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“…We feel therefore, that this should be considered as a potential first line therapy for all patients with ID. There are data in the adult literature demonstrating that correction of ID with FCM improves fatigue in a single dose (26). This would potentially have a similar effect in children, and so the ability to make a therapeutic difference with a single, rapid infusion should be considered.…”

Section: Discussionmentioning

confidence: 99%

Ferric carboxymaltose in the treatment of iron deficiency in pediatric inflammatory bowel disease

Carman¹,

Muir²,

Lewindon³

2019

Transl Pediatr

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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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“…Looking more closely, increase and normalization of phosphate levels was observed in the 12th week of observation. As it was previously shown in population of patients with IBD, both formulations are safe and effective in this group of patients [ 23 , 24 , 25 ].…”

Section: Discussionmentioning

confidence: 64%

Effect of Intravenous Iron Administration on Bone Mineral and Iron Homeostasis in Patients with Inflammatory Bowel Disease—Results of a Prospective Single-Centre Study

Tulewicz-Marti¹,

Szwarc²,

Więcek³

et al. 2023

JPM

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Introduction: Anaemia and bone metabolism alterations are common in inflammatory bowel disease (IBD), which is a heterogeneous group of diseases that include Crohn’s disease (CD) and ulcerative colitis (UC) with a rich intestinal and extraintestinal symptomatology. All these make the diagnostic procedures complicated and difficult. Purpose and scope: The aim of this study was to assess the effect of parenteral iron administration on biomarkers of mineral and bone homeostasis over time. Materials and methods: The study was a single-centre non-randomised prospective study. It was carried out between 2016 and 2020 in a group of patients in the Department of Internal Medicine and Gastroenterology Subunit of Inflammatory Bowel Diseases at the National Institute of Medicine of the Ministry of the Interior and Administration in Warsaw. At the first examination, the baseline disease severity, initial evaluation of anaemia (morphology, iron (Fe), total iron binding capacity (TIBC), ferritin, vitamin B12, folic acid) and bone mineral metabolism including C-reactive protein (CRP), albumins, alkaline phosphatase (ALP), Calcium, osteocalcin, phosphate in serum and in urine, parathyroid hormone( PTH), vitamin D3, fibroblast growth factor (iFGF23) and procollagen type 1N propeptide (P1NP) C-terminal telopeptide (CTX), was initially assessed. On the basis of peripheral blood counts, an appropriate dose of iron (iron derisomaltose or caboxymaltose) was administered. During the subsequent appointments on week 1, 4, and 12 morphology, iron (Fe), total iron binding capacity (TIBC), ferritin, vitamin B12, folic acid, C-reactive protein (CRP), albumins, alkaline phosphatase (ALP), Calcium, osteocalcin, phosphate in serum and in urine, parathyroid hormone (PTH), vitamin D3, fibroblast growth factor (iFGF23) and procollagen type 1N propeptide (P1NP) C-terminal telopeptide (CTX), were evaluated. Results: A total of 56 patients were enrolled into the study: 24 women and 32 men. In the group, 32 patients had Crohn’s disease (CD) and 24 had ulcerative colitis (UC). We found a statistically significant increase in the concentration of albumin (p = 0.031), haemoglobin (p < 0.001), haematocrit (p < 0.001), MCV (p < 0.001), MCHC (p = 0.001), iron (p < 0.001) and ferritin (p < 0.001) after the administration of parenteral iron. The influence of individual iron formulations on the analysed parameters (phosphate concentration in serum and in the urine, iFGF23, P1NP, PTH, vitamin D, haemoglobin and ferritin) was similar. Interestingly, an inverse correlation was found between the concentration of phosphorus in the blood and iFGF23 at certain time-points; however, in the study group they did not significantly affect the disturbances of calcium and phosphate metabolism. Conclusions: In the study group, transient and non-significant disorders of phosphate metabolism were found, which does not constitute a contraindication to treatment with parenteral iron in inflammatory bowel disease patients, which was safe and efficient.

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Safety and Efficacy of Ferric Carboxymaltose in the Treatment of Iron Deficiency Anaemia in Patients with Inflammatory Bowel Disease, in Routine Daily Practice

Abstract: Ferinject®-therapy was proven to be effective and safe in a large cohort of patients with IBD-associated anaemia in routine practice. Rapid, high-dose application is convenient for physicians and reduces patients' time lost from work.

Cited by 12 publications

References 30 publications

Effectiveness and safety of an on-demand ferric carboxymaltose infusion strategy in patients with inflammatory bowel disease: a real world experience

Effectiveness and safety of an on-demand ferric carboxymaltose infusion strategy in patients with inflammatory bowel disease: a real world experience

Ferric carboxymaltose in the treatment of iron deficiency in pediatric inflammatory bowel disease

Effect of Intravenous Iron Administration on Bone Mineral and Iron Homeostasis in Patients with Inflammatory Bowel Disease—Results of a Prospective Single-Centre Study

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