In a phase 3b trial comparing treatments for iron-deficiency anemia in inflammatory bowel disease, ferric maltol demonstrated clinical effectiveness but fell short of showing noninferiority to intravenous ferric carboxymaltose at week 12. Patients were randomized to receive either oral ferric maltol or intravenous ferric carboxymaltose, with the primary goal being to assess hemoglobin response rates. While ferric maltol showed significant hemoglobin increases, its responder rate was lower compared to ferric carboxymaltose (67% vs. 84% in intent-to-treat analysis).

Over the long term, both treatments showed similar effectiveness in improving hemoglobin and ferritin levels over 52 weeks. Ferric maltol was associated with higher rates of treatment-emergent adverse events (59%) and treatment discontinuations (10%) compared to ferric carboxymaltose. Despite not meeting the primary endpoint of noninferiority at week 12, ferric maltol still led to clinically relevant improvements in hemoglobin levels, suggesting it as a viable option for patients with nonseverely active inflammatory bowel disease and iron-deficiency anemia.

Reference: Howaldt S, Domènech E, Martinez N, Schmidt C, Bokemeyer B. Long-Term Effectiveness of Oral Ferric Maltol vs Intravenous Ferric Carboxymaltose for the Treatment of Iron-Deficiency Anemia in Patients With Inflammatory Bowel Disease: A Randomized Controlled Noninferiority Trial. Inflamm Bowel Dis. 2022 Mar 2;28(3):373-384. doi: 10.1093/ibd/izab073. Erratum in: Inflamm Bowel Dis. 2021 Oct 06;: PMID: 33988236; PMCID: PMC8889281..