Introduction
Iron deficiency (ID) and iron deficiency anaemia (IDA) are common complications of inflammatory bowel diseases (IBD). Ferric maltol is an oral iron therapy which increased haemoglobin within 12 weeks and sustainably improved the quality of life in patients with IBD and IDA. [1,2] While IDA is also frequently associated with pregnancy [3], there is no available data on the efficacy and safety of ferric maltol in pregnancy or in pregnant women with ID/IDA.
Aims & Methods
This study documented the first known clinical experience of ferric maltol in pregnant women with IBD and either ID or IDA. Retrospective clinical data from January 2017 to February 2023 in the MVZ Immunology database included pregnant patients with a confirmed diagnosis of IBD and treatment with ferric maltol during their pregnancy. The following patient data were collected: haematological parameters [haemoglobin (Hb), transferrin saturation level (TSAT), soluble transferrin receptor (stfR), ferritin], biomarkers for intestinal inflammation (calprotectin) and safety data. Descriptive results are reported here.
Results
A total of 27 female IBD patients with ID/IDA were included in this analysis, 11 with ulcerative colitis and 16 with Crohn's disease. The mean age was 35.9 years. A total of 29 pregnancies were treated with ferric maltol therapy (two patients had two pregnancies during this period). Prescriptions started after a mean of month 5 of pregnancy. In the course of most pregnancies, dosing was one capsule daily, as patients tended to have mild anemia. The number of prescribed boxes (56 capsules of ferric maltol: one capsule twice a day) per pregnancy was 1 in 82.8% [24/29], 2 in 13.8% [4/29], and 3 in 3.4% [1/29]. Nine cases with Hb < 11g/dl did take two capsules per day. After FM therapy, mean Hb levels increased from 11.3 to 12.36 g/dl (4-7 months), 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% (Table). Two patients developed side effects: One had new onset of abdominal pain shortly after starting, one had abdominal pain and increased meteorism. Both patients discontinued ferric maltol treatment and complaints then stopped. At the time of the current analysis, all 27 completed pregnancies proceeded without complications and ended with healthy neonatal infants without abnormalities. Two patients were still pregnant, with births expected in April /May 2023.
| Before FM
| After FM
|
Hb (g/dl), Mean
| 11.3
| 12.3 |
Hb (g/dl), Median
| 11.3 | 12.6 |
TSAT (%), Mean
| 17 | 15.4 |
TSAT (%), Median
| 13 | 12.5 |
stfR (mg/l), Mean
| 1.2 | 1.5 |
stfR (mg/l), Median
| 1.0 | 1.2 |
Ferritin ng/ml, Mean
| 27.2 | 30.0 |
Ferritin ng/ml, Median
| 9.0 | 16.5 |
Conclusion
These first clinical data on the use of ferric maltol in pregnancy suggest that ferric maltol appears to have a favourable safety profile with few side effects for pregnant patients with IBD and ID/IDA.
References
- Gasche C, et al. Inflamm Bowel Dis. 2015, 21(3):579-88
- J.P. Gisbert1, et al. UEG Journal 2022, Vol 10 (S8), MP323, p359
- Lopez A, et al. Lancet. 2016, 387(10021):907-16
Disclosure
Stefanie Howaldt has served as a speaker or has received research or education funding or advisory fees from MSD, AbbVie, Biogen, Celltrion, Hospira, Takeda, Pfizer, Pharmacosmos, Janssen, R-Biopharm, Norgine, Sandoz, and Shield Therapeutics. Angela Schüller has no conflicts of interest.
