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

Abstract

SummaryBackgroundFerric maltol was effective and well‐tolerated in iron deficiency anaemia patients with inflammatory bowel disease during a 12‐week placebo‐controlled trial.AimTo 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.MethodsAfter 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.Results111 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 One patient was withdrawn due to increased ulcerative colitis activity.ConclusionsNormal haemoglobin was observed in ≥80% of patients from weeks 20–64 of long‐term ferric maltol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.

Frequency, types, and treatment of anemia in Turkish patients with inflammatory bowel disease

“…Moreover, it has been shown that IV-administered iron has no effect on disease activity[ 45 ]. Since IDA has a tendency to recur in IBD, maintenance treatment should be continued for at least three months[ 46 ]. In cases of unresponsiveness to all types of anemia therapies, the patient should be referred to a hematologist[ 40 ].…”

Portuguese Consensus on Diagnosis, Treatment, and Management of Anemia in Pediatric Inflammatory Bowel Disease

“…If oral iron is considered a treatment option, the recommended dose is 3−6 mg/kg, up to a maximum of 100 mg/day. New iron formulations, as ferric maltol, have shown few side effects in adult patients with IBD, even in those with a history of intolerance to ferrous sulfate [62,63]. DOI: 10.1159/000505071 Statement 5 IV iron should be considered as first-line treatment for all pediatric IBD patients with Hb > 6 g/dL (with hemodynamic stability and no cardiovascular disease or other comorbidities).…”

Oral Iron for IBD Patients: Lessons Learned at Time of COVID-19 Pandemic

“…There was no difference in treatment compliance between the two groups (98% for both arms), and the percentage of adverse events between the experimental group and the control group was comparable (58% vs. 72%, respectively), indicating a good drug safety profile [20]. Long-term extension data of this Phase 3 trial confirmed the efficacy of ferric maltol [21]. In fact, 97 of the 111 patients who completed the first 12 study weeks were enrolled in an open-label trial, receiving ferric maltol 30 mg twice a day, for an additional 52 weeks [21].…”

“…Long-term extension data of this Phase 3 trial confirmed the efficacy of ferric maltol [21]. In fact, 97 of the 111 patients who completed the first 12 study weeks were enrolled in an open-label trial, receiving ferric maltol 30 mg twice a day, for an additional 52 weeks [21]. Patients who were treated with the placebo in the previous phase were switched to oral iron [21].…”