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Ferric maltol therapy for iron deficiency anaemia in patients with inflammatory bowel disease: long-term extension data from a Phase 3 study.
Schmidt, C. 1; Ahmad, T. 2; Tulassay, Z. 3; Baumgart, D. C. 4; Bokemeyer, B. 5; Howaldt, S. 6; Stallmach, A. 1; Buning, C. 7; the AEGIS Study Group; Baumgart, Daniel C.; Bokemeyer, Bernd; Buning, Carsten; Helwig, Ulf; Howaldt, Stefanie; Huppe, Dietrich; Krummenerl, Annette; Krummenerl, Thomas; Kuhbacher, Tanja; Landry, Wilfried; Lugering, Andreas; Maaser, Christian; Mro[latin sharp s], Michael; Seidler, Ursula; Stallmach, Andreas; Stein, Jurgen; Teich, Niels; Horvath, Gabor; Kristof, Tunde; Laszlo, Andras; Molnar, Tamas; Salamon, Agnes; Tulassay, Zsolt; Vincze, Aron; Krayenbuehl, Pierre; Ahmad, Tariq; Beales, Ian; Brookes, Matthew; Campbell, Simon; Cummings, Fraser; Ede, Ronald; Elphick, David; Ireland, Alan; Kejariwal, Deepak; Li, Andy; Mansfield, John
[Article] Alimentary Pharmacology & Therapeutics. 44(3):259-270, August 2016.

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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 [mu]g/L (baseline) to 26.0 [mu]g/L (Week 12) in ferric maltol-treated patients, and to 57.4 [mu]g/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.