Ferric Maltol Is Effective in Correcting Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease: Results from a Phase-3 Clinical Trial Program
What this study found
Ferric maltol improved hemoglobin more than placebo and was generally well tolerated. In the ferric maltol group, mean hemoglobin increased from 11.00 to 13.20 g/dL by week 12, compared with 11.10 to 11.20 g/dL with placebo, and the primary endpoint difference was significant (P < 0.0001). The adjusted mean treatment difference versus placebo was 1.04 g/dL at week 4 and 1.73 g/dL at week 8; the odds ratio for hemoglobin increases of at least 1 g/dL was 41.8 (95% CI, 13.5-129.9), and the odds ratio for hemoglobin normalization was 15.3 (95% CI, 5.9-39.3). Median time to hemoglobin…
- Study & population
- Phase 3 randomized, double-blind, placebo-controlled trial in adults with ulcerative colitis or Crohn's disease in remission or with mild-to-moderate disease activity and mild-to-moderate iron deficiency anemia.
- Intervention
- Oral ferric maltol capsules were given at 231.5 mg per capsule, equivalent to 30 mg elemental iron, twice daily in the morning and at night on an empty stomach with water for 12 weeks.
- Key limitation
- The treatment period was short at 12 weeks, so longer-term efficacy and safety were not established.
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Open PDFOriginal abstract
Background:Iron deficiency anemia (IDA) is frequently seen in inflammatory bowel disease. Traditionally, oral iron supplementation is linked to extensive gastrointestinal side effects and possible disease exacerbation. This multicenter phase-3 study tested the efficacy and safety of ferric maltol, a complex of ferric (Fe3+) iron with maltol (3-hydroxy-2-methyl-4-pyrone), as a novel oral iron therapy for IDA. Methods:Adult patients with quiescent or mild-to-moderate ulcerative colitis or Crohn's disease, mild-to-moderate IDA (9.5–12.0 g/dL and 9.5–13.0 g/dL in females and males, respectively), and documented failure on previous oral ferrous products received oral ferric maltol capsules (30 mg twice a day) or identical placebo for 12 weeks according to a randomized, double-blind, placebo-controlled study design. The primary efficacy endpoint was change in hemoglobin (Hb) from baseline to week 12. Safety and tolerability were assessed. Results:Of 329 patients screened, 128 received randomized therapy (64 ferric maltol-treated and 64 placebo-treated patients) and comprised the intent-to-treat efficacy analysis: 55 ferric maltol patients (86%) and 53 placebo patients (83%) completed the trial. Significant improvements in Hb were observed with ferric maltol versus placebo at weeks 4, 8, and 12: mean (SE) 1.04 (0.11) g/dL, 1.76 (0.15) g/dL, and 2.25 (0.19) g/dL, respectively (P < 0.0001 at all time-points; analysis of covariance). Hb was normalized in two-thirds of patients by week 12. The safety profile of ferric maltol was comparable with placebo, with no impact on inflammatory bowel disease severity. Conclusions:Ferric maltol provided rapid clinically meaningful improvements in Hb and showed a favorable safety profile, suggesting its possible use as an alternative to intravenous iron in IDA inflammatory bowel disease.