High-dose fast infusion of parenteral iron isomaltoside is efficacious in inflammatory bowel disease patients with iron-deficiency anaemia without profound changes in phosphate or fibroblast growth factor 23.
Iron isomaltoside (Monofer(®)) is a high-dose intravenous iron preparation with good tolerability and efficacy in inflammatory bowel disease (IBD) patients with iron deficiency anaemia (IDA). This trial evaluates the safety and efficacy, including effect on intact fibroblast growth factor 23 (iFGF23) of a high single dose and cumulative doses of iron isomaltoside in IBD patients with IDA.



The trial was a prospective, open-label, multi-centre trial conducted in IBD patients with IDA. Based upon haemoglobin (Hb) levels at baseline and weight, the patients received 1500, 2000, 2500 or 3000 mg of iron isomaltoside infused in single doses up to 2000 mg. The outcome measurements included adverse drug reactions (ADRs) and changes in haematology and biochemistry parameters.



Twenty-one IBD patients with IDA were enrolled, receiving 1500 (seven patients), 2000 (eight patients), 2500 mg (four patients) or 3000 (two patients) mg of iron. No serious ADRs were observed. Four patients experienced nine mild to moderate ADRs (hypersensitivity, pyrexia, vomiting, constipation, abdominal pain, dyspepsia (two events) and eye allergy (two events)). In total, 15 (75%) patients had an increase in Hb of ≥2.0 g/dL during the trial, with normalisation of ferritin. No changes in iFGF23 or clinically significant hypophosphataemia were found.



Rapid infusions of high-dose iron isomaltoside, administered as single doses up to 2000 mg and cumulative doses up to 3000 mg, were without safety concerns and were efficacious in increasing Hb levels in IBD patients. Iron isomaltoside did not induce profound phosphate wasting via increased iFGF23 levels.
a Department of Hepatology and Gastroenterology , Aarhus University Hospital , Aarhus , Denmark ;
Jens Frederik
JF
Dahlerup
b Department of Gastroenterology and Hepatology , Aalborg University Hospital , Aalborg , Denmark ;
Bent A
BA
Jacobsen
c Department of Gastroenterology and Hepatology , Erasmus MC Rotterdam , Rotterdam , the Netherlands ;
Janneke
J
van der Woude
d Department of Gastroenterology and Hepatology , Karolinska University Hospital , Stockholm , Sweden ;
Lars-Åke
LÅ
Bark
e Pharmacosmos A/S , Holbaek , Denmark ;
Lars L
LL
Thomsen
f Gastroenterology Division, Department of Clinical Sciences , Lund University, University Hospital Skane , Malmö , Sweden.
Stefan
S
Lindgren
D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy*; D003718:Denmark; D004187:Disaccharides / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D005293:Ferritins / Q000097:blood; D000089703:Fibroblast Growth Factor-23; D005346:Fibroblast Growth Factors / Q000097:blood*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000150:complications*; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D010710:Phosphates / Q000097:blood*; D011446:Prospective Studies; D011788:Quality of Life; D013548:Sweden; D055815:Young Adult
D004187:Disaccharides; C000717427:FGF23 protein, human; D005290:Ferric Compounds; D006454:Hemoglobins; D010710:Phosphates; C557707:iron isomaltoside 1000; D005346:Fibroblast Growth Factors; D000089703:Fibroblast Growth Factor-23; D005293:Ferritins
Anaemia; FGF23; IBD; hypophosphataemia; intravenous iron; iron deficiency; ferric derisomaltose