Ferric Carboxymaltose Versus Ferrous Fumarate in Anemic Children with Inflammatory Bowel Disease: The POPEYE Randomized Controlled Clinical Trial

Bevers, N; Vijver, Els Van de; Aliu, A; Ardabili, Ashkan Rezazadeh; Rosias, P; Stapelbroek, Janneke M.; Maartens, I A Bertrams; Feen, C van de; Escher, Johanna C.; Oudshoorn, A; Teklenburg, S; Velde, Saskia Vande; Winkens, Björn; Raijmakers, M; Vreugdenhil, A; Pierik, M J; Rheenen, Patrick F. van

doi:10.1016/j.jpeds.2022.12.016

Cited by 5 publications

(6 citation statements)

References 32 publications

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“…This cross-sectional study was nested in the POPEYE study, a recently reported randomized, multicenter controlled trial comparing the effects of oral versus intravenous iron on physical fitness and hemoglobin (Hb) (4). Recruitment took place from June 2015 until May 2019 at the outpatient clinics of 5 tertiary care centers and 6 large teaching hospitals in the Netherlands and Belgium.…”

Section: Study Populationmentioning

confidence: 99%

“…Little is known about the causes of fatigue in pediatric IBD, hampering its management. Most studies comparing fatigued and non-fatigued patients have been confined to biological factors (such as disease activity and anemia) (3,4). Information about functional factors such as physical activity (PA) and psychosocial factors in children and adolescents with IBD are scarce.…”

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confidence: 99%

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Fatigue and Physical Activity Patterns in Children With Inflammatory Bowel Disease

Bevers,

Van de Vijver,

Hanssen

et al. 2023

Journal of Pediatric Gastroenterology &Amp; Nutrition

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Objectives: Fatigue is a common symptom in children with inflammatory bowel disease (IBD). Diagnostic tests to evaluate biological causes of fatigue commonly include markers of inflammation and haemoglobin (Hb), yet functional parameters have been inadequately studied in paediatric IBD. In this study we compared fatigued and non-fatigued children with IBD from both a biological and functional point of view. Methods: A cross-sectional study of 104 paediatric IBD patients with mild to moderately active IBD was conducted. Fatigued children were defined as those with a Pediatric Quality of Life Inventory (PedsQL TM) Multidimensional Fatigue Scale Z-score <-2.0. Non-fatigued children had a Z-score ≥ -2.0. Disease-specific quality of life (measured with IMPACT-III score), C-reactive protein (CRP), faecal calprotectin (FC), haemoglobin Z-score (Hb Z-score) and physical activity tests including 6-minute walking distance Z-score (6MWD Z-score) and triaxial accelerometry (TA) were evaluated. Results: Fatigued children (n=24) had a significant lower IMPACT-III score than non-fatigued children (n=80). Hb Z-scores, CRP, FC and 6 MWD Z-scores were not significantly different between groups. TA was performed in 71 patients. Wear time validation requirements were met in only 31 patients. Fatigued patients spent significant shorter median time in moderate-to-vigorous activity than non-fatigued patients (18.3 versus 37.3 minutes per day, P=0.008). Conclusion: Biological parameters did not discriminate fatigued from non-fatigued patients. TA possibly distinguishes fatigued from non-fatigued patients; the potential association may provide a target for interventions to combat fatigue and improve quality of life.

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Section: Study Populationmentioning

confidence: 99%

mentioning

confidence: 99%

Fatigue and Physical Activity Patterns in Children With Inflammatory Bowel Disease

Bevers,

Van de Vijver,

Hanssen

et al. 2023

Journal of Pediatric Gastroenterology &Amp; Nutrition

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“…The primary endpoint was a change in the 6-min walking distance (6MWD) from baseline, expressed as z-score, while the secondary outcome was the change in Hb z-score compared to pretreatment values. One month after the start of iron therapy, the 6MWD z-score of patients in the FCM group had increased by 0.71 compared with 0.11 in the oral group, a significant difference validating that a single dose of FCM is superior to oral ferrous fumarate with respect to quick improvement of physical fitness [53].…”

Section: Ferric Carboxymaltose (Fcm)mentioning

confidence: 86%

“…A Dutch multicenter study tested whether intravenous or oral iron supplementation is superior in improving physical fitness in 64 anemic children with IBD [53]. Children aged 8-18 years with IBD and anemia defined as hemoglobin z-score < 2 were randomly assigned to a single dose of FCM (33 children) or 12 weeks of oral ferrous fumarate (31 children).…”

Section: Ferric Carboxymaltose (Fcm)mentioning

confidence: 99%

Parenteral Iron Therapy for Pediatric Patients

Mantadakis,

Alexiadou,

Zikidou

2024

Hemato

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Iron deficiency (ID) is by far the most common nutritional disorder in developing and developed countries. When left untreated, ID leads to anemia. Although the usually recommended treatment for iron deficiency anemia (IDA) is oral iron therapy with countless products, such therapy necessitates administration for >3–6 months with questionable patient compliance since most oral iron products have an unpleasant metallic aftertaste and cause intestinal side effects. In addition, in certain gastrointestinal conditions, such as inflammatory bowel diseases or untreated gluten-sensitive enteropathy, oral iron therapy is contraindicated or unsuccessful. Intravenous iron is considered safe in adults, where adverse events are mild and easily managed. The experience with parenteral iron in children is much more limited, and many pediatricians appear reluctant to use it because of uncorroborated fears of serious anaphylactic reactions. In the current article, we thoroughly review the available pediatric literature on the use of all commercially available parenteral iron products except ferumoxytol, which was recently removed from the market. We conclude that parenteral iron appears to be safe in children; it works faster than oral iron, and the newer third-generation products allow replacement of the total iron deficit in a single sitting.

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“…12 The safety and efficacy of oral and intravenous iron in patients with IBD have been proven. [13][14][15][16] Intravenous iron significantly increases haemoglobin and ferritin over the course of several weeks; however serious adverse events (SAEs) occur in approximately 5% of cases. 17 18 In contrast, oral iron is associated with more frequent gastrointestinal side effects than intravenous iron (OR=3.14, 95% CI 1.34-7.36, p=0.008, I 2 =0%) and can lead to poor treatment adherence or discontinuation.…”

Section: Open Accessmentioning

confidence: 99%

Predicting response to iron supplementation in patients with active inflammatory bowel disease (PRIme): a randomised trial protocol

Loveikyte,

Duijvestein,

Mujagic

et al. 2024

BMJ Open

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IntroductionIron deficiency anaemia (IDA) is the most common systemic manifestation of inflammatory bowel disease (IBD) that has detrimental effects on quality of life (QoL) and disease outcomes. Iron deficiency (ID), with or without anaemia, poses a diagnostic and therapeutic challenge in patients with IBD due to the multifactorial nature of ID(A) and its frequent recurrence. Elevated hepcidin—a systemic iron regulator that modulates systemic iron availability and intestinal iron absorption—has been associated with oral iron malabsorption in IBD. Therefore, hepcidin could assist in therapeutic decision-making. In this study, we investigate whether hepcidin can predict response to oral and intravenous iron supplementation in patients with active IBD undergoing anti-inflammatory treatment.Methods and analysisPRIme is an exploratory, multicentre, open-label and randomised trial. All adult patients with active IBD and ID(A) will be assessed for eligibility. The participants (n=90) will be recruited at five academic hospitals within the Netherlands and randomised into three groups (1:1:1): oral ferrous fumarate, oral ferric maltol or intravenous iron. Clinical and biochemical data will be collected at the baseline and after 6, 14 and 24 weeks. Blood samples will be collected to measure hepcidin and other biomarkers related to iron status. In addition, patient-reported outcomes regarding QoL and disease burden will be evaluated. The primary outcome is the utility of hepcidin as a predictive biomarker for response to iron therapy, which will be assessed using receiver operating curve analysis.Ethics and disseminationThe study has been approved by the Institutional Review Board at the Leiden University Medical Center (IRB No. P21.109) and other study sites. All participants will provide written informed consent to enrol in the study. The findings will be published in a peer-reviewed journal and disseminated at scientific conferences; the dataset will be available on reasonable request.Trial registrationProspectively registered in thehttps://clinicaltrials.gov/and the Eudra registries. First submitted on 10 May 2022 to the ClinicalTrials.gov (ID:NCT05456932) and on 3 March 2022 to the European Union Drug Regulating Authorities Clinical Trials Database (ID: 2022-000894-16).

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Ferric Carboxymaltose Versus Ferrous Fumarate in Anemic Children with Inflammatory Bowel Disease: The POPEYE Randomized Controlled Clinical Trial

Cited by 5 publications

References 32 publications

Fatigue and Physical Activity Patterns in Children With Inflammatory Bowel Disease

Fatigue and Physical Activity Patterns in Children With Inflammatory Bowel Disease

Parenteral Iron Therapy for Pediatric Patients

Predicting response to iron supplementation in patients with active inflammatory bowel disease (PRIme): a randomised trial protocol

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