J Clin Med. 2022 May 15;11(10):2786. doi: 10.3390/jcm11102786.

Jose María Huguet ¹, Xavier Cortés ², Marta Maia Boscá-Watts ³, Margarita Muñoz ⁴, Nuria Maroto ⁵, Marisa Iborra ⁶, Esther Hinojosa ⁵, María Capilla ¹, Carmina Asencio ⁷, Cirilo Amoros ⁸, Jose María Paredes ⁷

Author information

¹Gastroenterology Department, Hospital General Universitario de Valencia, 46014 Valencia, Spain.

²Gastroenterology Department, Hospital de Sagunto, 46520 Valencia, Spain.

³Gastroenterology Department, Hospital Clínico Universitario de Valencia, University of Valencia, 46010 Valencia, Spain.

⁴Gastroenterology Department, Hospital General Universitario de Castellón, 12004 Castesllon de la Plana, Spain.

⁵Gastroenterology Department, Hospital de Manises, 46940 Valencia, Spain.

⁶Gastroenterology Department, Hospital Universitario y Politécnico de La Fe, 46026 Valencia, Spain.

⁷Gastroenterology Department, Hospital Universitario Doctor Peset, 46017 Valencia, Spain.

⁸Gastroenterology Department, Hospital Arnau de Vilanova de Valencia, 46015 Valencia, Spain.

Abstract

Background: Iron deficiency (ID) without anaemia is a common comorbidity associated with inflammatory bowel disease (IBD) that has a negative impact on health-related quality of life (HRQoL).

Methods: This multicentre, prospective, observational study examined the response to, safety of and impact on HRQoL of a single 500 mg dose of intravenous ferric carboxymaltose (FCM) in patients with IBD and ID without anaemia. The diagnostic criteria for ID were low serum ferritin (<30 µg/L in the absence of inflammatory activity or <100 µg/L with inflammation) and transferrin saturation index (TSAT) < 16%. The effect on iron levels and HRQoL, according to the health status questionnaires SF-12v2 and EQ-5D, was evaluated 1 month after FCM infusion in an outpatient setting.

Results: Of the 105 patients who received FCM, 98 patients completed the study. After 1 month, a single dose of FCM significantly increased serum ferritin, serum iron and TSAT. Importantly, patients reported fewer ID symptoms and problems on all EQ-5D dimensions. They also had higher EQ-5D visual analogue scale and SF-12v2 scores after treatment. FCM had similar clinical effects on men and women and on patients with Crohn's disease (n = 66) and ulcerative colitis (n = 32).

Conclusion: A single dose of FCM rapidly restored iron parameters and significantly improved patients' symptoms and HRQoL at 1 month after treatment.