title: A 1-year trial of repeated high-dose intravenous iron isomaltoside 1000 to maintain stable hemoglobin levels in inflammatory bowel disease.
abstract: Iron isomaltoside 1000 (Monofer®) is a high-dose intravenous (IV) iron, which in a recent 8 weeks trial in inflammatory bowel disease (IBD) subjects with iron deficiency anemia (IDA) demonstrated good tolerability and efficacy. The present trial is an extension to this trial, which evaluates the need for additional high IV iron doses to maintain a stable hemoglobin (Hb) ≥12.0 g/dl.
  
  
  
  This was a prospective, open-label, 12 months trial of European IBD subjects willing to participate after completing the lead-in trial. Subjects were allowed re-dosing with 500-2000 mg single doses of iron isomaltoside 1000 infused over ∼15 min at 3 months intervals depending on a predefined algorithm. Outcome measures included Hb, safety parameters and need for additional iron dosing.
  
  
  
  A total of 39 subjects were enrolled of which 34 subjects required re-dosing with a median cumulative 1-year dose of 1.8 g (mean cumulative dose 2.2 g). The mean (SD) Hb was 12.3 (1.5) g/dl at baseline, 12.8 (1.6) g/dl at 3 months, 12.8 (1.6) g/dl at 6 months, 12.9 (1.4) g/dl at 9 months and 12.9 (1.6) g/dl at 12 months. Seventy-four percent of subjects who had an Hb ≥12.0 g/dl at baseline were able to maintain Hb ≥12.0 g/dl till the end of the trial at 12 months. Nonserious probably related hypersensitivity reactions without significant hypotension were reported at the beginning of the infusion in two subjects, who recovered without sequelae.
  
  
  
  Repeated treatment of iron deficiency with iron isomaltoside 1000 could avoid episodes of IDA without major safety issues.
authors.affiliation: Department of Internal Medicine III, Medical University of Vienna, AKH , Vienna , Austria.
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
authors.forename: Istvan
authors.initials: I
authors.lastname: Altorjay
authors.forename: Ferenc
authors.initials: F
authors.lastname: Zsigmond
authors.forename: Christian
authors.initials: C
authors.lastname: Primas
authors.forename: Harald
authors.initials: H
authors.lastname: Vogelsang
authors.forename: Gottfried
authors.initials: G
authors.lastname: Novacek
authors.forename: Sieglinde
authors.initials: S
authors.lastname: Reinisch
authors.forename: Lars L
authors.initials: LL
authors.lastname: Thomsen
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000209:etiology*; D001317:Austria; D004187:Disaccharides / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D006814:Hungary; D015212:Inflammatory Bowel Diseases / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004187:Disaccharides; D005290:Ferric Compounds; C557707:iron isomaltoside 1000
keywords: anemia; inflammatory bowel disease; intravenous iron; iron deficiency; ferric derisomaltose