Observational Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Apr 26, 2023; 11(12): 2740-2752
Published online Apr 26, 2023. doi: 10.12998/wjcc.v11.i12.2740
Ferric carboxymaltose for anemia in Crohn’s disease patients at a tertiary center: A retrospective observational cohort study
Natália Souza Nunes Siqueira, Livia Bitencourt Pascoal, Bruno Lima Rodrigues, Marina Moreira de Castro, Alan Sidnei Corrêa Martins, Dante Orsetti Silva Araújo, Luis Eduardo Miani Gomes, Michel Gardere Camargo, Maria de Lourdes Setsuko Ayrizono, Raquel Franco Leal
Natália Souza Nunes Siqueira, Livia Bitencourt Pascoal, Bruno Lima Rodrigues, Marina Moreira de Castro, Alan Sidnei Corrêa Martins, Dante Orsetti Silva Araújo, Luis Eduardo Miani Gomes, Michel Gardere Camargo, Maria de Lourdes Setsuko Ayrizono, Raquel Franco Leal, Inflammatory Bowel Disease Research Laboratory, Gastrocenter, Colorectal Surgery Unit, School of Medical Sciences, University of Campinas (Unicamp), Campinas 13083-878, São Paulo, Brazil
Author contributions: Siqueira NSN, Castro MM, Martins ASC, and Araújo DOS were responsible for collecting the data; Siqueira NSN, Pascoal LB, Castro MM, and Gomes LEM plotted and analyzed the data; Siqueira NSN, Leal RF, Pascoal LB, and Castro MM contributed to interpreting the results; Leal RF conceived the study and performed the final revision of the manuscript; All authors contributed to the writing and revised the manuscript; All authors read and approved the final manuscript.
Supported by the National Council for Scientific and Technological Development (CNPq), No. 302557/2021-0 (to Leal RF), the Brazilian Coordination for the Improvement of Higher Education Personnel [CAPES (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior), Brazil], No. 001 (to Siqueira NSN), and the São Paulo Research Foundation (FAPESP), No. 2021/02997-9 (to D.O.S.A.).
Institutional review board statement: The study was approved by the University of Campinas Ethics Committee, No. CAAE:56915516.6.0000.5404.
Informed consent statement: Patients were informed, but written consent was waived due to the retrospective methodology of the study. All efforts were made to ensure data confidentiality, as required by the Ethics Committee. This study was performed in accordance with the Declaration of Helsinki, good clinical practice, and applicable regulatory requirements.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: The data used to support the findings of this study are included within the article. No additional data are available.
STROBE statement: The authors have read the STROBE Statement checklist of items, and the manuscript was prepared and revised according to the STROBE Statement checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Raquel Franco Leal, MD, PhD, Associate Professor, Senior Researcher, Inflammatory Bowel Disease Research Laboratory, Gastrocenter, Colorectal Surgery Unit, School of Medical Sciences, University of Campinas (Unicamp), Carlos Chagas Street, 420, Cidade Universitária Zeferino Vaz, Campinas 13083-878, São Paulo, Brazil. rafranco.unicamp@gmail.com
Received: December 28, 2022
Peer-review started: December 28, 2022
First decision: February 15, 2023
Revised: February 20, 2023
Accepted: March 23, 2023
Article in press: March 23, 2023
Published online: April 26, 2023
Processing time: 118 Days and 5.4 Hours
Abstract
BACKGROUND

Although the gastrointestinal tract is the most affected by Crohn’s disease (CD), the condition triggers other consequent manifestations, and iron deficiency anemia (IDA) is one of the most common. Intravenous (IV) iron replacement is currently available through several drugs, such as ferric hydroxide sucrose and ferric carboxymaltose (FCM). However, the clinical management of these conditions can be challenging.

AIM

To elucidate the drug’s effectiveness, the present study analyzed, through medical records, the clinical and epidemiological data of a cohort of patients with active CD who received IV FCM for the IDA treatment.

METHODS

This retrospective observational study included 25 patients with active CD, severe anemia, and refractory to previous conventional treatments. Patients were evaluated two times: During the last treatment with ferric hydroxide sucrose and treatment with FCM.

RESULTS

After treatment with FCM, parameters of IDA assessment significantly improved, serum hemoglobin (Hb) levels increased in 93% of patients (P < 0.0001), and in 44%, there was an increase of ≥ 2 g/dL in a single application. In addition, 86% of the patients showed an increase in serum iron (P < 0.0001) and ferritin (P = 0.0008) and 50% in transferrin saturation (P = 0.01). The serum iron levels at baseline showed a negative association with the ileal and colonic CD and use of biologics and a positive association with patients who developed CD later in life after the age of 40 (A3) and with a stenosing (B2) and fistulizing (B3) phenotype. The values of Hb and hematocrit after ferric hydroxide sucrose treatment remained similar to those found before treatment.

CONCLUSION

This study demonstrated that FCM is an important therapeutic strategy for treating IDA in CD patients, achieving satisfactory results in refractory cases.

Keywords: Ferric carboxymaltose; Iron deficiency anemia; Crohn’s disease; Inflammatory bowel disease; Anemia; Clinical management

Core Tip: In this observational cohort study, treatment with a single dose of ferric carboxymaltose demonstrated a significant improvement in the hematological parameters evaluated for the treatment of iron deficiency anemia in Crohn’s disease patients at a tertiary center of a developing country. These results may contribute to guiding clinical treatment of this condition, mainly in cases of refractoriness to ferric hydroxide sucrose.