Ferric carboxymaltose for anemia in Crohn’s disease patients at a tertiary center: A retrospective observational cohort study

Table 1 Demographic and clinical characteristics of the patients included in the study

Variables	Ferric carboxymaltose	Iron sucrose	P value
Sex (M/F)	12/13	9/7	0.606a
Age (yr)	37 (20-67)	37 (25-67)	0.989b
Disease duration (mo)	144 (6-312)	144 (24-312)	0.718b
Age at the diagnostic A1/A2/A31	1/22/2	1/14/1	0.931a
Disease location L1/L2/L3/L41	5/4/16/0	4/3/9/0	0.882a
Behavior B1/B2/B31	8/13/4	4/8/4	0.750a
Perianal disease (yes/no)	11/14	8/8	0.707a
Prior Surgery (yes/no)	20/05	15/1	0.224a
Biologic therapy (yes/no)	23/2	15/1	0.962a
Immunosuppressive therapy (yes/no)	14/11	13/3	0.242a
Previous blood transfusion (yes/no)	10/15	8/8	0.529a

¹Montreal classification.

^aPearson's χ² test.

^bUnpaired t-test (Mann Whitney) with P < 0.05.

Numerical variables are described in median (minimum and maximum), and the categorical variables in absolute frequency. n = 25. CD: Crohn’s disease; M: Male; F: Female.

Table 2 Evaluation of the laboratory parameters in the patients who received ferric carboxymaltose

Variables	Pre-therapy	Post-therapy	P value
Hemoglobin (mg/dL)	8.5 (5.8-10)	10.1 (7.8-13.7)	< 0.0001
Haematocrit (%)	27.8 (19.7-32.29)	33 (25.9-42.8)	< 0.0001
Ferritin (ng/dL)	23.79 (0.5-475.4)	100.38 (4.26-826.1)	0.0008
Iron (mcg/dL)	15 (4-43)	26 (10-64.52)	< 0.0001
STAT (mcg/dL)	3.5 (1-21)	9 (2-26.3)	0.01
MCV (fL)	74.6 (57.8-92.9)	80.8 (64.4-97.8)	0.05
HCM (pg)	22.3 (14.4-37.2)	23.6 (18.5-30.7)	0.15
MCHC (g/dL)	30.1 (24.9-38.8)	30.65 (26.4-33.9)	0.48
Platelets (× 10³/µL)	410 (200-888)	321 (201-708)	0.19

Numerical variables are described in the median (minimum and maximum). n = 25. Unpaired t-test (Mann Whitney) with P < 0.05. MCV: Mean Corpuscular Volume; HCM: Mean Corpuscular Hemoglobin; MCHC: Mean Corpuscular Hemoglobin Concentration; STAT: Transferrin saturation.

Table 3 Multiple linear regression analysis of clinical and demographic characteristics associated with serum iron, ferritin, and transferrin saturation in Crohn's disease patients

Variables	β value	95%CI	P value
Serum iron levels at baseline
Age at the diagnostic1
A3	50.119	(15.778, 84.459)	0.004
Disease location1
L3	-16.328	(-30.601, -2.055)	0.025
Behavior1
B2	18.357	(4.711, 32.002)	0.008
B3	21.961	(2.931, 40.992)	0.024
Biologic therapy
Yes	-27.271	(-53.623, -0.919)	0.043
Serum ferritin levels after FCM injection
Disease location1
L2	348.460	(56.087, 640.833)	0.019
Behavior1
B3	335.922	(57.389,614.454)	0.018
STAT at baseline
Behavior1
B2	8.033	(1.974, 14.091)	0.009
B3	13.866	(5.762, 21.971)	0.001
Perianal disease
Yes	10.5	(3.907, 17.092)	0.002

¹Montreal classification.

Analysis of multiple linear regression with P < 0.05. n = 25. FCM: Ferric carboxymaltose; STAT: Transferrin saturation.

Table 4 Main features of ferric carboxymaltose versus iron hydroxide sucrose

	Ferric carboxymaltase[38]	Iron hydroxide sucrose[39]
Concentration	Up to 20 mL corresponding to 1000 mg of iron	10 mL corresponding to 200 mg of iron
Dosage	1 time a week	1 to 3 times a week (depending on hemoglobin level)
Infusion time	Up to 200 mg of iron - there is no established administration time from 200 mg to 500 mg of iron – the rate of 100 mg per minute above 500 mg up to 1000 mg of iron -66 mg per min	Up to 200 mg of iron - 6.6 mg per min, 300 mg of iron -3.3 mg per min, 400 mg - 2.6 mg per min, 500 mg - 2.3 mg per min
Molecule	Stable iron is in the form of a complex of non-dextran iron with a polynuclear ferric hydroxide core with a carbohydrate linker. Because of the high stability of the complex, there is only a small amount of weakly bound iron (also called free iron). The structure of the nucleus is similar to that of ferritin, so the complex is intended to provide a controlled supply of usable iron for ferric transport and storage of proteins in the body	Trivalent form as a macromolecular colloidal complex of ferric hydroxide saccharate. The polynuclear ferric hydroxide core is superficially surrounded by a large number of non-covalently linked sucrose molecules, resulting in a complex whose molecular mass is approximately 43 kDa
Pharmacokinetics	After administration of a single dose of iron carboxymaltose of 100 to 1000 mg of iron in patients with anemia, peak serum iron concentrations were between 37 and 333 mcg per mL	After the injection of 100mg of iron in healthy individuals, the maximum plasma concentration, on average, of 538 µmol per L, 10 min after the injection
Volume of distribution	The volume of distribution of the central compartment corresponds to the plasma volume (approximately 3 L). It is retained mainly in the reticuloendothelial system of the bone marrow, liver, and spleen. The average residence time varied between 11 and 17 h	The central compartment volume of distribution correlates well with serum volume (approximately 3 L). The volume of distribution at a steady state was about 8 L, which indicates the low distribution of iron in body fluids
Half-life	7 and 12 h	6 h
Route of administration	Intravenous injectable solution	Intravenous injectable solution