Inflammatory Bowel Disease

Iron deficiency (ID) can compound the burden of inflammatory bowel disease (IBD). Without treatment, ID and iron deficiency anemia (IDA) can significantly worsen symptoms.49

Prevalence of ID and IDA

ID is common in IBD — affecting up to 90% of patients — yet over 50% of people diagnosed with IDA remain untreated.49

For patients who do receive treatment, traditional oral ferrous salts often present their own challenges. These formulations dissociate in the stomach, increasing the risk of reactive oxygen species (ROS) formation, which can lead to GI side effects and decreased absorption.3,6,54

The Patient

Woman smiling in front of a yellow background

*Not actual patient.

Melissa*

51-year-old white female with mild-to-moderate Crohn’s disease and IDA

Lab Makers Melissa's Labs

Hb

10.2 g/dL

Ferritin

9 μg/L

TSAT

10%

Common complaints: 

  • Shortness of breath and dizziness
  • Symptoms include diarrhea, abdominal pain, cramping, and fatigue
  • Oral ferrous sulfate isn’t tolerated because of GI side effects
  • Also concerned about exacerbating her Crohn’s disease


Pertinent medical history and medication list: 

  • Last Crohn’s disease flare was approximately 6 months ago
  • Medications include mesalamine and azathioprine for Crohn’s disease

The ACCRUFeR Difference

ACCRUFeR® (ferric maltol) established safety and efficacy treating ID/IDA in adults with Crohn’s disease and ulcerative colitis, who had previously failed treatment with oral ferrous products, in two 12-week, phase 3A, randomized and placebo-controlled pivotal trials with a 52-week open label extension phase.1,2,5

In clinical studies, ACCRUFeR demonstrated:

  • Significant Hb Improvements: 2.25 (0.12) g/dL LS mean (SE) improvement in Hb in the ACCRUFeR group vs 0.06 (0.13) in the placebo at Week 12.2
  • Rapid Results: Statistically significant increase in Hb as early as Week 4.2
  • Proven Efficacy: 86.1% of patients taking ACCRUFeR maintained normal Hb levels at Week 64.*,1,2
  • No Negative Impact on Inflammation: No worsening of inflammation in the 12-week double-blind phase of trials with patients with IBD.6,54
  • Unprecedented Tolerability: 4.6% of patients (n=175) discontinued ACCRUFeR because of adverse reactions compared to 2.5% of patients (n=120) on placebo.2,^

*At Week 12, patients on placebo switched to ACCRUFeR, and patients already on ACCRUFeR continued for an additional 52 weeks. The study started with 64 patients taking ACCRUFeR and 64 taking the placebo. By the end of the study, 71 patients were still taking ACCRUFeR (35 from the original ACCRUFeR group and 36 from the group that switched from placebo to ACCRUFeR).|

^Adverse reactions that were reported by ≥1% of patients treated with ACCRUFeR during double-blind phases of the placebo-controlled period of pooled studies (AEGIS IBD and AEGIS CKD).

More about ACCRUFeR's clinical studies

About ACCRUFeR

See how ACCRUFeR's MALTOL SHIELDTM helps minimize the risk of gastrointestinal side effects.2-4

Established Safety and Efficacy

ACCRUFeR is backed by a robust clinical profile. It has demonstrated both short- and long-term efficacy across three pivotal clinical studies.

References:
1. Schmidt C, Ahmad T, Tulassay Z, et al. Ferric maltol therapy for iron deficiency anaemia in patients with inflammatory bowel disease: long-term extension data from a phase 3 study. Aliment Pharmacol Ther. 2016;44(3):259-270. doi:10.1111/apt.13665

2. ACCRUFeR® full prescribing information. Shield Therapeutics, 2025.
3. Stallmach A, Büning C. Ferric maltol (ST10): a novel oral iron supplement for the treatment of iron deficiency anemia in inflammatory bowel disease. Expert Opin Pharmacother. 2015;16(18):2859-2867. doi:10.1517/14656566.2015.1096929
4. European Medicines Agency. Accessed March 17, 2021. https://www.ema.europa.eu/en/documents/variation-report/feraccru-h-c-2733-ii-0010-epar-assessment-report-variation_en.pdf
5. Gasche C, Ahmad T, Tulassay Z, et al. Ferric maltol is effective in correcting iron deficiency anemia in patients with inflammatory bowel disease: results from a phase-3 clinical trial program. Inflamm Bowel Dis. 2015;21(3):579-588. doi:10.1097/mib.0000000000000314
6. Pergola PE, Kopyt NP. Oral ferric maltol for the treatment of iron-deficiency anemia in patients with CKD: a randomized trial and open-label extension. Am J Kidney Dis. 2021;78(6):846-856.el. doi:10.1053/j.ajkd.2021.03.020
49. Cappellini MD, Comin-Colet J, de Francisco A, et al. IRON CORE Group. Iron deficiency across chronic inflammatory conditions: International expert opinion on definition, diagnosis, and management. Am J Hematol. 2017 Oct;92(10):1068- 1078. doi: 10.1002/ajh.24820. Epub 2017 Jul 7. PMID: 28612425; PMCID: PMC5599965.
54. Data on File. Shield Therapeutics Inc. 2015