Hypophosphataemia following ferric derisomaltose and ferric carboxymaltose in patients with iron deficiency anaemia due to inflammatory bowel disease (PHOSPHARE-IBD) : A randomised clinical trial
(2023) In Gut 72(4). p.644-653- Abstract
Objective: Intravenous iron - a common treatment for anaemia and iron deficiency due to inflammatory bowel disease (IBD) - can cause hypophosphataemia. This trial compared the incidence of hypophosphataemia after treatment with ferric carboxymaltose (FCM) or ferric derisomaltose (FDI). Design: This randomised, double-blind, clinical trial was conducted at 20 outpatient hospital clinics in Europe (Austria, Denmark, Germany, Sweden, UK). Adults with IBD and iron deficiency anaemia (IDA) were randomised 1:1 to receive FCM or FDI at baseline and at Day 35 using identical haemoglobin- and weight-based dosing regimens. The primary outcome was the incidence of hypophosphataemia (serum phosphate <2.0 mg/dL) at any time from baseline to Day... (More)
Objective: Intravenous iron - a common treatment for anaemia and iron deficiency due to inflammatory bowel disease (IBD) - can cause hypophosphataemia. This trial compared the incidence of hypophosphataemia after treatment with ferric carboxymaltose (FCM) or ferric derisomaltose (FDI). Design: This randomised, double-blind, clinical trial was conducted at 20 outpatient hospital clinics in Europe (Austria, Denmark, Germany, Sweden, UK). Adults with IBD and iron deficiency anaemia (IDA) were randomised 1:1 to receive FCM or FDI at baseline and at Day 35 using identical haemoglobin- and weight-based dosing regimens. The primary outcome was the incidence of hypophosphataemia (serum phosphate <2.0 mg/dL) at any time from baseline to Day 35 in the safety analysis set (all patients who received ≥1 dose of study drug). Markers of mineral and bone homeostasis, and patient-reported fatigue scores, were measured. Results: A total of 156 patients were screened; 97 (49 FDI, 48 FCM) were included and treated. Incident hypophosphataemia occurred in 8.3% (4/48) FDI-treated patients and in 51.0% (25/49) FCM-treated patients (adjusted risk difference: -42.8% (95% CI -57.1% to -24.6%) p<0.0001). Both iron formulations corrected IDA. Patient-reported fatigue scores improved in both groups, but more slowly and to a lesser extent with FCM than FDI; slower improvement in fatigue was associated with greater decrease in phosphate concentration. Conclusion: Despite comparably effective treatment of IDA, FCM caused a significantly higher rate of hypophosphataemia than FDI. Further studies are needed to address the longer-term clinical consequences of hypophosphataemia and to investigate mechanisms underpinning the differential effects of FCM and FDI on patient-reported fatigue.
(Less)
- author
- Zoller, Heinz ; Wolf, Myles ; Blumenstein, Irina ; Primas, Christian ; Lindgren, Stefan LU ; Thomsen, Lars L. ; Reinisch, Walter and Iqbal, Tariq
- organization
- publishing date
- 2023
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- anemia, IBD, iron deficiency
- in
- Gut
- volume
- 72
- issue
- 4
- pages
- 644 - 653
- publisher
- BMJ Publishing Group
- external identifiers
-
- scopus:85139217342
- pmid:36343979
- ISSN
- 0017-5749
- DOI
- 10.1136/gutjnl-2022-327897
- language
- English
- LU publication?
- yes
- id
- 35bd6e2b-c009-4a28-832a-f639bb1a8c5e
- date added to LUP
- 2022-12-14 12:59:11
- date last changed
- 2024-06-24 20:32:30
@article{35bd6e2b-c009-4a28-832a-f639bb1a8c5e,
abstract = {{<p>Objective: Intravenous iron - a common treatment for anaemia and iron deficiency due to inflammatory bowel disease (IBD) - can cause hypophosphataemia. This trial compared the incidence of hypophosphataemia after treatment with ferric carboxymaltose (FCM) or ferric derisomaltose (FDI). Design: This randomised, double-blind, clinical trial was conducted at 20 outpatient hospital clinics in Europe (Austria, Denmark, Germany, Sweden, UK). Adults with IBD and iron deficiency anaemia (IDA) were randomised 1:1 to receive FCM or FDI at baseline and at Day 35 using identical haemoglobin- and weight-based dosing regimens. The primary outcome was the incidence of hypophosphataemia (serum phosphate <2.0 mg/dL) at any time from baseline to Day 35 in the safety analysis set (all patients who received ≥1 dose of study drug). Markers of mineral and bone homeostasis, and patient-reported fatigue scores, were measured. Results: A total of 156 patients were screened; 97 (49 FDI, 48 FCM) were included and treated. Incident hypophosphataemia occurred in 8.3% (4/48) FDI-treated patients and in 51.0% (25/49) FCM-treated patients (adjusted risk difference: -42.8% (95% CI -57.1% to -24.6%) p<0.0001). Both iron formulations corrected IDA. Patient-reported fatigue scores improved in both groups, but more slowly and to a lesser extent with FCM than FDI; slower improvement in fatigue was associated with greater decrease in phosphate concentration. Conclusion: Despite comparably effective treatment of IDA, FCM caused a significantly higher rate of hypophosphataemia than FDI. Further studies are needed to address the longer-term clinical consequences of hypophosphataemia and to investigate mechanisms underpinning the differential effects of FCM and FDI on patient-reported fatigue.</p>}},
author = {{Zoller, Heinz and Wolf, Myles and Blumenstein, Irina and Primas, Christian and Lindgren, Stefan and Thomsen, Lars L. and Reinisch, Walter and Iqbal, Tariq}},
issn = {{0017-5749}},
keywords = {{anemia; IBD; iron deficiency}},
language = {{eng}},
number = {{4}},
pages = {{644--653}},
publisher = {{BMJ Publishing Group}},
series = {{Gut}},
title = {{Hypophosphataemia following ferric derisomaltose and ferric carboxymaltose in patients with iron deficiency anaemia due to inflammatory bowel disease (PHOSPHARE-IBD) : A randomised clinical trial}},
url = {{http://dx.doi.org/10.1136/gutjnl-2022-327897}},
doi = {{10.1136/gutjnl-2022-327897}},
volume = {{72}},
year = {{2023}},
}