Ferric maltol therapy for iron deficiency anaemia in patients with inflammatory bowel disease: long‐term extension data from a Phase 3 study

BACKGROUND: Ferric maltol was effective and well‐tolerated in iron deficiency anaemia patients with inflammatory bowel disease during a 12‐week placebo‐controlled trial. AIM: To perform a Phase 3 extension study evaluating long‐term efficacy and safety with ferric maltol in inflammatory bowel disease patients in whom oral ferrous therapies had failed to correct iron deficiency anaemia. METHODS: After 12 weeks of randomised, double‐blind treatment, patients with iron deficiency anaemia and mild‐to‐moderate ulcerative colitis or Crohn's disease received open‐label ferric maltol 30 mg b.d. for 52 weeks. RESULTS: 111 patients completed randomised treatment and 97 entered the open‐label ferric maltol extension. In patients randomised to ferric maltol (‘continued’; n = 50), mean ± s.d. haemoglobin increased by 3.07 ± 1.46 g/dL between baseline and Week 64. In patients randomised to placebo (‘switch’; n = 47), haemoglobin increased by 2.19 ± 1.61 g/dL. Normal haemoglobin was achieved in high proportions of both continued and switch patients (89% and 83% at Week 64, respectively). Serum ferritin increased from 8.9 μg/L (baseline) to 26.0 μg/L (Week 12) in ferric maltol‐treated patients, and to 57.4 μg/L amongst all patients at Week 64. In total, 80% of patients reported ≥1 adverse event by Week 64. Adverse events considered related to ferric maltol were recorded in 27/111 (24%) patients: 8/18 discontinuations due to adverse events were treatment‐related. One patient was withdrawn due to increased ulcerative colitis activity. CONCLUSIONS: Normal haemoglobin was observed in ≥80% of patients from weeks 20–64 of long‐term ferric maltol treatment, with concomitant increases in iron storage parameters. Ferric maltol was well‐tolerated throughout this 64‐week study.