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Hypophosphataemia following ferric derisomaltose and ferric carboxymaltose in patients with iron deficiency anaemia due to inflammatory bowel disease (PHOSPHARE-IBD): a randomised clinical trial

Department of Medicine I and Christian Doppler Laboratory on Iron and Phosphate Biology, Medical University of Innsbruck, Innsbruck, Austria heinz.zoller@i-med.ac.at. Division of Nephrology, Department of Medicine, and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA. Medical Clinic I, Department of Gastroenterology, Hepatology, and Clinical Nutrition, University Clinic Frankfurt, Frankfurt, Germany. Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria. Department of Gastroenterology and Hepatology, Skåne University Hospital Malmö, Lund University, Lund, Sweden. Department of Clinical and Non-Clinical Research, Pharmacosmos A/S, Holbæk, Denmark. Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria. Department of Gastroenterology, Queen Elizabeth Hospital Birmingham, Birmingham, UK.

Gut. 2022
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PICO Summary

Population

Adults with inflammatory bowel disease and iron deficiency anaemia enrolled in the PHOSPHARE-IBD trial in five European countries (n= 97).

Intervention

Ferric carboxymaltose (FCM), (n= 48).

Comparison

Ferric derisomaltose (FDI), (n= 49).

Outcome

Incident hypophosphataemia occurred in 8.3% FDI-treated patients and in 51% FCM-treated patients (adjusted risk difference: -42.8% (95% CI -57.1% to -24.6%)). Both iron formulations corrected iron deficiency anaemia. 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.
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 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.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine