Ferric Maltol Safe for Pregnant Patients with IBD, Iron Deficiency Anemia, Study Finds

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Findings from a retrospective study of pregnant patients with inflammatory bowel disease (IBD) treated with ferric maltol are providing clinicians with an overview of the treatment’s favorable safety profile and lack of side effects.

Presented at United European Gastroenterology Week 2023, the study offers the first clinical data on the use of ferric maltol in pregnant patients with iron deficiency or iron deficiency anemia.¹

“Iron deficiency and iron deficiency anaemia are common complications of inflammatory bowel diseases,” wrote Stefanie Howaldt, MD, of Hamburg Research Institute for Inflammatory Bowel Diseases.¹ “While iron deficiency anaemia is also frequently associated with pregnancy, there is no available data on the efficacy and safety of ferric maltol in pregnancy or in pregnant women with iron deficiency and iron deficiency anaemia.”

A blood disorder affecting red blood cells, iron-deficiency anemia is the most common form of anemia and occurs when the body does not produce enough iron to make hemoglobin.² According to the American Society of Hematology, women who are pregnant are at a greater risk of iron-deficiency anemia.³ Patients with IBD are also at risk of developing anemia due to the impact of intestinal inflammation, intestinal bleeding, and poor absorption of vitamins and minerals on iron absorption and utilization.⁴ Little is known about the use of ferric maltol in pregnant patients with IBD, meriting further research given this group’s increased risk of developing the condition.

To assess the safety and efficacy of ferric maltol in pregnant women with IBD and iron deficiency/iron deficiency anemia, Howaldt collected clinical data for 27 pregnant female patients with a confirmed diagnosis of IBD and treatment with ferric maltol during their pregnancy from the MVZ Immunology database from January 2017 to February 2023. Among the cohort, 11 participants had ulcerative colitis (UC), 16 had Crohn disease (CD) and the mean age was 35.9 years. A total of 29 pregnancies were treated with ferric maltol therapy during the study period.¹

Howaldt collected data for hematological parameters including hemoglobin (Hb), transferrin saturation level (TSAT), soluble transferrin receptor (stfR), and ferritin. Data for biomarkers for intestinal inflammation (calprotectin) and safety data were also collected.¹

Among the cohort, prescriptions started after a mean of month 5 of pregnancy. Dosing was 1 capsule daily during most pregnancies in the study, although 9 cases with Hb < 11g/dl took 2 capsules per day. After ferric maltol therapy, Howaldt pointed out mean Hb levels increased from 11.3 to 12.36 g/dl, mean stfR levels increased from 1.2 to 1.5 mg/l, and mean ferritin levels increased from 27.2 to 30.0 ng/l, while mean TSAT decreased slightly from 17% to 15.4%.¹

During the study period, 2 patients developed side effects including new onset of abdominal pain shortly after starting treatment and increased meteorism. Upon discontinuation of ferric maltol treatment, complaints of side effects from both patients stopped. All 27 pregnancies completed within the study period proceeded without complications and ended with healthy neonatal infants without abnormalities, with the exception of 2 patients who were still pregnant and expecting births in April/May 2023.¹

“These first clinical data on the use of ferric maltol in pregnancy suggest that ferric maltol appears to have a favorable safety profile with few side effects for pregnant patients with IBD and ID/IDA,” concluded Howaldt.¹

References:

1. Howalt, S. FIRST CLINICAL EXPERIENCE OF ORAL FERRIC MALTOL TREATMENT IN PREGNANT WOMEN WITH INFLAMMATORY BOWEL DISEASE AND IRON DEFICIENCY ANAEMIAS. Data presented at: United European Gastroenterology Week 2023; October 14 – 17; Copenhagen, Denmark. Accessed October 20, 2023.
2. Cleveland Clinic. Iron-deficiency Anemia. Diseases & Conditions. April 21, 2022. Accessed October 20, 2023. https://my.clevelandclinic.org/health/diseases/22824-iron-deficiency-anemia
3. American Society of Hematology. Iron-deficiency Anemia. Anemia. Accessed October 20, 2023. https://www.hematology.org/education/patients/anemia/iron-deficiency
4. Crohn’s and Colitis Foundation. ANEMIA. EMR IBD Education Tool. February 3, 2020. Accessed October 20, 2023. https://www.crohnscolitisfoundation.org/emr/emr-ibd-education-tool/anemia