Iron Status and Analysis of Efficacy and Safety of Ferric Carboxymaltose Treatment in Patients with Inflammatory Bowel Disease

Abstract

Background and Aims: We analyzed iron deficiency and the therapeutic response following intravenous ferric carboxymaltose in a large single-center inflammatory bowel disease (IBD) cohort. Methods: 250 IBD patients were retrospectively analyzed for iron deficiency and iron deficiency anemia. A subgroup was analyzed regarding efficacy and side effects of iron supplementation with ferric carboxymaltose. Results: In the cohort (n = 250), 54.4% of the patients had serum iron levels ≤60 µg/dl, 81.2% had ferritin ≤100 ng/ml, and 25.6% had hemoglobin (Hb) of ≤12 g/dl (females) or ≤13 g/dl (males). In the treatment subcohort (n = 80), 83.1% of the patients had iron ≤60 µg/dl, 90.4% had ferritin ≤100 ng/ml, and 66.7% had Hb ≤12/13 g/dl before ferric carboxymaltose treatment. After a median dose of 500 mg ferric carboxymaltose, 74.7% of the patients reached iron >60 µg/dl, 61.6% had ferritin >100 ng/ml, and 90.7% reached Hb >12/13 g/dl at follow-up (p < 0.0001 for all parameters vs. pretreatment values). The most frequent adverse event was a transient increase of liver enzymes with male gender as risk factor (p = 0.008, OR 8.62, 95% CI 1.74–41.66). Conclusions: Iron deficiency and anemia are frequent in IBD patients. Treatment with ferric carboxymaltose is efficious, safe and well tolerated in iron-deficient IBD patients.

Iron Deficiency in the Absence of Anemia Impairs the Perception of Health-Related Quality of Life of Patients with Inflammatory Bowel Disease

“…ID in patients with IBD has been reported to be around 40% and even as high as 80%. 26,27 Our study, although not directly designed to determine the prevalence of ID in IBD, confirms that ID is frequent, as we found that 43% of included patients were iron deficient. ID usually goes unrecognized and little is known about its clinical impact.…”

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

“…Most trials 14,22,42,45,46,[48][49][50][51][52][53][54][55] included adult patients only (≥18 years), while two additionally enrolled adolescent IBD patients ≥16 years 43 or ≥15 years, 44 respectively. Garcia-Lopez et al included adults and adolescents ≥15 years, stating a mean of 42.8 years and SD 16.3.…”

“…Records excluded on full text (n = 10) Not RCT: 9 Not exclusively iron monotherapy: 1 studies of various designs were included in the systematic review. 14,[43][44][45][46][48][49][50][51] One small crossover study 56 was carefully considered for inclusion but finally excluded on the grounds of a lack of sufficient data on response rates and missing confirmation of anaemia before the second study phase. In summary, the systematic review included six RCTs and nine studies of other designs assessing the efficacy of specific intravenous iron solutions.…”

“…According to the outcomes of these studies, response rates were 70-86% for FCM, 65-80% for IS and 51% for IDX (one study). In total, the systematic review included five studies with 505 patients for FCM, 22,44,49,50,52 eight studies with 508 patients for IS, 22,42,43,45,48,51,53,55 two studies with 78 patients for IDX 14,46 and one study with 219 patients for ISM as infusion or bolus injection. 54 Overall response rates were 401/505 (79%) for FCM, 344/508 (68%) for IS, 147/ 219 (67%) for ISM and 33/78 (42%) for IDX.…”

“…In five studies assessing FCM, patients received one to three 15-min intravenous applications in single doses of 500-1000 mg per infusion. 22,44,49,50,52 In contrast, IS was applied in single doses of 200 mg in 1-11 infusions over 30 min. 22,42,43,45,48,51,53,55 While data concerning the number of infusions of IDX were not clear in the two studies included, 14,46 one mentioned that 53 infusions in total had been applied to 36 patients.…”