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


Journal

European journal of gastroenterology & hepatology
ISSN: 1473-5687
Titre abrégé: Eur J Gastroenterol Hepatol
Pays: England
ID NLM: 9000874

Informations de publication

Date de publication:
01 06 2022
Historique:
pubmed: 2 2 2022
medline: 3 5 2022
entrez: 1 2 2022
Statut: ppublish

Résumé

We evaluated an on-demand ferric carboxymaltose (FCM) infusion strategy in inflammatory bowel disease (IBD) patients with iron deficiency anemia (IDA). 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. 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. 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. An on-demand strategy was effective and well-tolerated in treating IDA in IBD patients.

Sections du résumé

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.

Identifiants

pubmed: 35102111
doi: 10.1097/MEG.0000000000002348
pii: 00042737-202206000-00003
doi:

Substances chimiques

Ferric Compounds 0
ferric carboxymaltose 6897GXD6OE
Maltose 69-79-4

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

607-612

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Informations de copyright

Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.

Références

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WHO, UNICEF, UNU. Iron deficiency anemia: assessment, prevention and control. Report of a joint WHO/UNICEF/UNU consultation. Geneva: World Health Organization; 1998.
Lugg S, Beal F, Nightingale P, Bhala N, Iqbal T. Iron treatment and inflammatory bowel disease: what happens in real practice? J Crohns Colitis 2014; 8:876–880.
Erichsen K, Hausken T, Ulvik RJ, Svardal A, Berstad A, Berge RK. Ferrous fumarate deteriorated plasma antioxidant status in patients with Crohn disease. Scand J Gastroenterol 2003; 38:543–548.
Dignass AU, Gasche C, Bettenworth D, Birgegård G, Danese S, Gisbert JP, et al.; European Crohn’s and Colitis Organisation [ECCO]. European consensus on the diagnosis and management of iron deficiency and anaemia in inflammatory bowel diseases. J Crohns Colitis 2015; 9:211–222.
Wang C, Graham DJ, Kane RC, Xie D, Wernecke M, Levenson M, et al. Comparative risk of anaphylactic reactions associated with intravenous iron products. JAMA 2015; 314:2062–2068.
Stein J, Aksan A, Klemm W, Nip K, Weber-Mangal S, Dignass A. Safety and efficacy of ferric carboxymaltose in the treatment of iron deficiency anaemia in patients with inflammatory bowel disease, in routine daily practice. J Crohns Colitis 2018; 12:826–834.
Evstatiev R, Marteau P, Iqbal T, Khalif IL, Stein J, Bokemeyer B, et al.; FERGI Study Group. FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease. Gastroenterology 2011; 141:846–853.e1.
Aksan A, Işik H, Radeke HH, Dignass A, Stein J. Systematic review with network meta-analysis: comparative efficacy and tolerability of different intravenous iron formulations for the treatment of iron deficiency anaemia in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2017; 45:1303–1318.
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Auteurs

Mauro Grova (M)

Department of Health Promotion Sciences Maternal and Infant Care, Section of Gastroenterology and Hepatology, Internal Medicine and Medical Specialties, PROMISE, University of Palermo.
Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo.

Federica Crispino (F)

Department of Health Promotion Sciences Maternal and Infant Care, Section of Gastroenterology and Hepatology, Internal Medicine and Medical Specialties, PROMISE, University of Palermo.
Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo.

Marcello Maida (M)

Department of Gastroenterology and Digestive Endoscopy, Section of Gastroenterology, "S. Elia-Raimondi" Hospital, Caltanissetta, Italy.

Sara Renna (S)

Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo.

Mariella Mannino (M)

Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo.

Angelo Casà (A)

Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo.

Giulia Rizzuto (G)

Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo.

Fabio Salvatore Macaluso (FS)

Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo.

Ambrogio Orlando (A)

Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo.

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