BACKGROUND & AIMS: Iron-deficiency anemia is the most common systemic 
complication of inflammatory bowel diseases (IBD). Iron-deficiency anemia recurs 
frequently and rapidly after iron-replacement therapy in patients with IBD. We 
performed a randomized, placebo-controlled trial to determine if administration 
of ferric carboxymaltose (FCM) prevents anemia in patients with IBD and low 
levels of serum ferritin.
METHODS: We performed a single-blind, multicenter study of nonanemic patients 
who had completed the FERGIcor study. Serum levels of ferritin were assessed 
every second month, and patients were given FCM (total iron dose, 1181 ± 662 mg; 
n = 105) or placebo (n = 99) when levels decreased to less than 100 μg/L. The 
primary end point was time to recurrence of anemia within 8 months. Secondary 
end points included changes of quality of life, disease activity, results from 
laboratory tests, and adverse events.
RESULTS: Anemia recurred in 26.7% of subjects given FCM and in 39.4% given 
placebo. The time to anemia recurrence was longer in the FCM group (hazard 
ratio, 0.62; 95% confidence interval, 0.38-1.00; P = .049). Markers of body 
levels of iron increased or remained at normal levels in subjects given FCM 
(ferritin increased by 30.3 μg/L, transferrin saturation increased by 0.6%) but 
decreased in the group given placebo (ferritin decreased by 36.1 μg/L, 
transferrin saturation decreased by 4.0%). Changes in quality of life and 
disease activity were comparable between groups. Adverse events were reported in 
59.0% of the FCM group and 50.5% of the placebo group, and serious adverse 
events were reported in 6.7% and 8.1%, respectively.
CONCLUSIONS: FCM prevents recurrence of anemia in patients with IBD, compared 
with placebo. Nevertheless, the high rate of anemia recurrence warrants 
optimization of the frequency and requirements for FCM treatment.