Introduction
Iron malabsorption (FeM) may lead to iron deficiency anaemia (IDA). Its most common causes are celiac disease (CD) due to atrophy of the small intestine mucosa, corpus atrophic gastritis (CAG), and gastric surgery (GS): reduced hydrochloric acid secretion derived from corpus oxyntic mucosa atrophy or surgical resection causes a decreased conversion of Fe(III)ion to Fe(II)ion, the latter being the more easily absorbable form. IDA affects more than two billion people over the world and it can cause troublesome symptoms as asthenia and fatigability. Iron oral supplementation is considered the standard therapy but frequently it leads to side effects reducing long-term compliance. Ferric carboxymaltose (FCM) is an intravenous (iv) preparation shown to be safe and effective in improving the iron status (FeS), but its efficacy in patients with FeM and IDA has not been investigated so far.
Aims & Methods
To evaluate the safety, efficacy and quality of life impact of iv FCM in treating pts with IDA due to FeM. A prospective observational single centre study was conducted on 37 pts with IDA caused by CAG (n=19/51.4%), CD (n=9/24.3%), and GS (n=9/24.3%). Pts with other causes of IDA as GI bleeding were excluded. At baseline (T0), pts were clinically and biochemically evaluated (symptoms, SF12, CBC and FeS: ferritin, iron, transferrin, transferrin saturation (TS)). FCM dosage was calculated according to Ganzoni formula considering Hb values and body weight. If the dosage needed was up to 1000mg, iv infusion was scheduled in a single session, otherwise a 2 nd infusion after 1 wk was planned. After treatment, CBC and FeS were assessed at 4 (T4) and 12 (T12) wks. SF12 was revaluated after 12 wks (cut-off physical component summary (PCS)<44, mental component summary (MCS)<46). IDA was defined as Hb<13 and <12 g/dl for men and women, ferritin<45 ng/dl or TS<15%. Moderate and severe anemia were defined as Hb 8-10 and Hb<8 g/dl. Student’s t-test was used to compare CBC and FeS parameters at baseline (T0), 4 weeks (T4) and 12 weeks (T12).
Results
All 37 patients completed 12-wks-follow-up. At T0 Hb was mean±SEM 10.9±0,2g/dl, 18.9% had moderate and 2.7% severe anaemia. In pts treated in a single-session-infusion (64.9%), dosage of FCM was mean±SEM 975±12mg; in pts treated in two sessions (35.1%), FCM dosage was mean±SEM 1400±77mg. One patient reported mild side effects (pruritus, cutaneous erythema) not requiring FCM interruption and reversing after H2 antagonist treatment within 15 minutes. At T4 and T12, 70.4% and 78.4% of pts recovered from IDA. At T4 mean Hb significantly increased compared to T0 (12.7±0.2 vs 10.8±0.2 g/dl, p<0.0001). At T12 a further increase was observed (13.1±0.2 g/dl, p<0.05). Also, TS increased from 6% at T0 to 20% at T12, p<0.0001. At T4 ferritin levels (ng/dl) significantly increased compared to T0, but slightly decreased at T12 (T0 28.5±11.2 vs T4 188.2±25.7, p<0.0001; T12 124.9±25.7, p=0.10). RDW (%) significantly increased at T4 and significantly decreased at T12(T0 15.4±0.5 vs T4 18.6±0.7, p=0.0003; T12 14.8±0.4, p<0.0001). The proportion of patients with SF12 MCS>46 and PCS>44 scores significantly increased at T12 compared to T0 indicating improved mental and physical health perception after FCM treatment.
Conclusion
In pts with IDA due to FeM, ivFCM is an effective and safe treatment, leading to recovery of IDA in nearly 80% of cases at 12 weeks after treatment and concomitantly to an improved mental and physical health perception. These data show that ivFCM treatment could be considered as a first line treatment for IDA patients with FeM.
References
Lahner E, et al. Dig Liver Dis. 2019 Dec;51(12):1621-1632. doi: 10.1016/j.dld.2019.09.016. Epub 2019 Oct 19. PMID: 31635944.
Elli L, et al. Nat Rev Gastroenterol Hepatol. 2024 Mar;21(3):198-215. doi: 10.1038/s41575-023-00872-2. Epub 2023 Dec 18. PMID: 38110546.
Carabotti M et al. Nutrients. 2021 Jan 13;13(1):208. doi: 10.3390/nu13010208. PMID: 33450823; PMCID: PMC7828248.
Kodraliu G et al. J Epidemiol Biostat. 2001;6(3):305-16. doi: 10.1080/135952201317080715. PMID: 11437095.