September 14, 2022 Publication of the Phosphare-IBD study in Gut

PRESS RELEASE
Pharmacosmos, Holbaek, September 14th 2022

The results of the PHOSPHARE-IBD study comparing the effect of ferric derisomaltose (FDI) and ferric carboxymaltose (FCM) on hypophosphataemia in patients with iron deficiency anaemia (IDA) due to inflammatory bowel disease (IBD) have been published in the scientific journal Gut1.
The study concludes that FCM caused a significantly higher rate of hypophosphatemia than FDI. Both treatments corrected IDA. Among additional endpoints, patient-reported fatigue scores improved in both groups, but more slowly and to a lesser extent with FCM 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.

about PHOSPAHARE ibd


The trial is the first double-blind, randomised, controlled trial to use an identical dosing regimen to directly compare the effect of FCM and FDI on hypophosphataemia, specifically in an IBD population.
The trial was conducted at 20 outpatient hospital clinics in 5 European countries. 97 (49 FDI, 48 FCM) patients were included and treated. 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.
PHOSPHARE IBD Results
The primary endpoint 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).
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, -24.6) p<0.0001]). Both iron formulations corrected IDA with comparable effects on (Hb) and iron stores.
Additional endpoints included measurement and analysis of markers of mineral and bone homeostasis, patient-reported fatigue scores, haemoglobin (Hb) concentrations and adverse events (AEs).
Among the additional endpoints and analyses, the publication highlights the following in the section “What this study adds”:

  • “Patient-reported fatigue scores improved in both treatment groups, but improvement in patients treated with FDI was faster and greater than in those receiving FCM” (statistically significantly at day 35 and day 49; numerically, but not statistically significantly at day 14 and day 70). A post-hoc analysis showed “Slower improvement in fatigue was associated with more severe hypophosphataemia.”
  • “Compared with FDI, hypophosphataemia after FCM was associated with more pronounced increases in intact FGF23, renal phosphate excretion, and PTH, and more pronounced decreases in 1,25-dihydroxyvitamin D.“ 

aBOUT THE PUBLICATION


  • Published in Gut, a leading BMJ journal in gastroenterology and hepatology
  • Title: Hypophosphatemia following ferric derisomaltose and ferric carboxymaltose in patients with iron deficiency anemia due to inflammatory bowel disease (PHOSPHARE IBD): A randomised clinical trial
  • Authors’ list: Heinz Zoller, Myles Wolf, Irina Blumenstein, Christian Primas, Stefan Lindgren, Lars Lykke Thomsen, Walter Reinisch, Tariq Iqbal

About ferric derisomaltose


Ferric derisomaltose/Iron isomaltoside 1000 (brand names Monofer® or Monoferric®) is an iron-carbohydrate complex for intravenous administration. Monofer® is marketed in more than 30 countries worldwide for the treatment of iron deficiency and iron deficiency anaemia. Monofer® is manufactured by Pharmacosmos A/S, Denmark.

For more information, please contact:
Chief Medical Officer, Lars Lykke Thomsen, MD
Phone: +45 59 48 59 59

1. Published on 10 September 2022. Ref. Zoller H, et al. Gut 2022;0:1–10. doi:10.1136/gutjnl-2022-327897

About Pharmacosmos Group


Pharmacosmos Group, headquartered in Holbaek, Denmark, and founded in 1965, is a highly specialised company focused on carbohydrate chemistry and a global leader in the development of innovative treatments for patients suffering from iron deficiency and iron deficiency anaemia. With companies in the UK, Nordics, Germany, the USA, and China, as well as through partners, Pharmacosmos markets its products around the world. With a strong and ongoing commitment to R&D, Pharmacosmos is able to leverage a unique carbohydrate production platform along with deep expertise in the synthesis of iron-carbohydrate complexes. The Pharmacosmos Group has approximately 500 employees.

Pharmacosmos

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