Abstract
Summary
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 One patient was withdrawn due to increased ulcerative colitis activity.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.