Ferric Carboxymaltose Versus Ferrous Fumarate in Anemic Children with Inflammatory Bowel Disease: The POPEYE Randomized Controlled Clinical Trial - 05/05/23
, Els Van de Vijver, PhD, MD 2, Arta Aliu 1, Ashkan Rezazadeh Ardabili, MD 3, Philippe Rosias, MD, PhD 1, Janneke Stapelbroek, MD, PhD 4, Imke A. Bertrams Maartens, MD 5, Cathelijne van de Feen, MD 6, Hankje Escher, MD, PhD 7, Annemarie Oudshoorn, MD 8, Sarah Teklenburg, MD, PhD 9, Saskia Vande Velde, MD, PhD 10, Bjorn Winkens, PhD 11, Maarten Raijmakers, PhD 12, Anita Vreugdenhil, MD, PhD 13, Marieke J. Pierik, MD, PhD 14, Patrick F. van Rheenen, MD, PhD 15Abstract |
Objective |
To determine whether intravenous (IV) or oral iron suppletion is superior in improving physical fitness in anemic children with inflammatory bowel disease (IBD).
Study design |
We conducted a clinical trial at 11 centers. Children aged 8-18 with IBD and anemia (defined as hemoglobin [Hb] z-score < −2) were randomly assigned to a single IV dose of ferric carboxymaltose or 12 weeks of oral ferrous fumarate. Primary end point was the change in 6-minute walking distance (6MWD) from baseline, expressed as z-score. Secondary outcome was a change in Hb z-score from baseline.
Results |
We randomized 64 patients (33 IV iron and 31 oral iron) and followed them for 6 months. One month after the start of iron therapy, the 6MWD z-score of patients in the IV group had increased by 0.71 compared with −0.11 in the oral group (P = .01). At 3- and 6-month follow-ups, no significant differences in 6MWD z-scores were observed. Hb z-scores gradually increased in both groups and the rate of increase was not different between groups at 1, 3, and 6 months after initiation of iron therapy (overall P = .97).
Conclusion |
In this trial involving anemic children with IBD, a single dose of IV ferric carboxymaltose was superior to oral ferrous fumarate with respect to quick improvement of physical fitness. At 3 and 6 months after initiation of therapy, no differences were discovered between oral and IV therapies. The increase of Hb over time was comparable in both treatment groups.
Trial registration |
NTR4487 [Netherlands Trial Registry].
Le texte complet de cet article est disponible en PDF.Keywords : children, anemia, iron suppletion, Crohn's disease, ulcerative colitis
Abbreviations : AEs, FCM, Hb, IBD, ICC, IV, I2, MCID, NNTB, PUCAI, PCDAI, RCT, RR, sTfR, TSAT, 6MWD
Plan
| Presented as an e-poster at ECCO congress 2021. |
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| Supported through an unrestricted grant from Vifor Pharma, Glattbrugg, Switzerland; they had no role in the design nor in the collection, analysis, and interpretation of data, the writing of the report or the decision to submit the paper for publication. |
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| The authors declare no conflicts of interest. |
Vol 256
P. 113 - mai 2023 Retour au numéro
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