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Ferric maltol viable alternative for iron deficiency anemia in IBD
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Ferric maltol, a novel oral iron therapy, safely and rapidly improved hemoglobin in inflammatory bowel disease patients with iron deficiency anemia, suggesting its potential as an alternative to IV iron, according to recent phase 3 clinical trial data.
In order to determine the efficacy and acceptability of ferric maltol for the treatment of iron deficiency anemia in patients with IBD, Christoph Gasche, MD, from the division of gastroenterology and hepatology at the Medical University of Vienna, and colleagues conducted two identical randomized, double blind clinical trials. At multiple centers in Austria, Germany, Hungary and the United Kingdom, patients with mild-to-moderate ulcerative colitis or Crohn’s disease and mild-to-moderate iron deficiency anemia who had prior treatment failure with oral ferrous products were randomly assigned to 231.5 mg ferric maltol twice daily or placebo for 12 weeks after a 1- to 2-week screening period. Changes in hemoglobin concentration, clinical symptoms, disease-specific quality of life and safety and tolerability were assessed throughout the study period.
Christoph Gasche
Of 329 patients screened, 64 received ferric maltol and 64 received placebo. Eighty-six percent of those who received ferric maltol and 83% who received placebo completed the trial. Hemoglobin levels improved significantly in the treatment group compared with placebo at weeks 4 (mean, 1.04 g/dL), 8 (mean, 1.76 g/dL) and 12 (mean, 2.25 g/dL; all P < .0001). Two-thirds of patients achieved hemoglobin normalization by week 12 (66% vs. 13% with placebo; OR = 15.3; 95% CI, 5.9-39.3). The safety profile of ferric maltol was comparable to placebo, with treatment-emergent adverse events occurring in 58% vs. 72%, respectively, and did not affect IBD severity.
Ferric maltol “provided rapid and clinically meaningful improvements in [hemoglobin] concentration, normalized [hemoglobin] in the majority of patients, and showed a favorable safety and tolerability profile,” the researchers wrote. “The favorable gastrointestinal tolerability with ferric maltol compared with currently available oral ferrous iron products, which is at least in part due to the lower doses of elemental iron allowed by this novel iron-maltol complex formulation, suggests that it may serve as an alternative to intravenous iron therapy in patients with IBD.”
However, it is “too early for definitive conclusions,” Gasche told Healio Gastroenterology, adding that “head-to-head trials will follow.” – by Adam Leitenberger
Disclosure: Gasche reports he has received research grant and consultancy honoraria from Vifor International, speaker honoraria from Vifor Österreich, Vifor International, Fresenius Medical Care, Renapharma and Biogena, and research grants from Vifor International and AOP Pharmaceuticals. Please see the full study for a list of all other authors’ relevant financial disclosures.
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