Colon to Rectum
Inflamm Bowel Dis. 2022;28(3):373–84
Long-term effectiveness of oral ferric maltol versus intravenous ferric carboxymaltose for the treatment of iron-deficiency anemia in patients with inflammatory bowel disease: A randomized controlled non-inferiority trial
Background: Iron-deficiency anemia is common in inflammatory bowel disease, requiring oral or intravenous iron replacement therapy. Treatment with standard oral irons is limited by poor absorption and gastrointestinal toxicity. Ferric maltol is an oral iron designed for improved absorption and tolerability.
Methods: In this open-label, phase 3b trial, adults with non-severely active inflammatory bowel disease and iron-deficiency anemia (hemoglobin, 8.0–11.0/12.0 g/dl [women/men]; ferritin, < 30 ng/ml/< 100 ng/ml with transferrin saturation < 20%) were randomized to oral ferric maltol 30 mg twice daily or intravenous ferric carboxymaltose given according to each center’s standard practice. The primary end point was a hemoglobin responder rate (≥ 2 g/dl increase or normalization) at week 12, with a 20% non-inferiority limit in the intention-to-treat (ITT) and per-protocol (PP) populations.
Results: For the ITT (ferric maltol, n = 125/ferric carboxymaltose, n = 125) and PP (n = 78/88) analyses, week 12 responder rates were 67% and 68%, respectively, for ferric maltol versus 84% and 85%, respectively, for ferric carboxymaltose. As the confidence intervals crossed the non-inferiority margin, the primary end point was not met. Mean hemoglobin increases at weeks 12, 24, and 52 were 2.5 versus 3.0 g/dl, 2.9 versus 2.8 g/dl, and 2.7 versus 2.8 g/dl with ferric maltol versus ferric carboxymaltose. Treatment-emergent adverse events occurred in 59% and 36% of patients, respectively, and resulted in treatment discontinuation in 10% and 3% of patients, respectively.
Conclusions: Ferric maltol achieved clinically relevant increases in hemoglobin but did not show non-inferiority versus ferric carboxymaltose at week 12. Both treatments had comparable long-term effectiveness for hemoglobin and ferritin over 52 weeks and were well tolerated.