title: Safety of ferric carboxymaltose immediately after infliximab administration, in a single session, in inflammatory bowel disease patients with iron deficiency: a pilot study.
abstract: OBJECTIVE
  To obtain preliminary safety and efficacy data on intravenous (IV) administration of infliximab (IFX) and ferric carboxymaltose (FCM) to inflammatory bowel disease (IBD) patients in a single treatment session.
  
  
  METHODS
  A two-phase non-interventional, observational, prospective pilot study was performed to evaluate safety and efficacy of FCM given immediately after IFX. IBD patients were recruited consecutively in the outpatient clinic in two groups. Control group patients (n = 12) received FCM on a separate day from IFX. Subsequently, single-session group patients (n = 33) received FCM after IFX on the same day. All patients received 5mg/kg IFX and 1000mg FCM for iron-restricted anemia (IRA) or 500mg FCM for iron deficiency without anemia. Safety assessment was performed by recording adverse events (AEs) during and immediately after infusion, 30 minutes afterwards, and via follow-up at 7 days and 8 weeks. For efficacy assessment, hematological parameters were assessed prior to FCM infusion (pre-FCM) and after 8 weeks. Economic impact of FCM given immediately after IFX was assessed.
  
  
  RESULTS
  All 45 patients (35 Crohn´s disease, 10 ulcerative colitis) received IFX 5mg/kg. 21 patients received 500mg FCM and 24 received 1000mg. FCM administration immediately after IFX corrected iron deficiency or IRA as shown by increases in hematological parameters. No AEs were reported during the safety evaluation at the end of FCM or IFX administration, 30 minutes, 7 days and 8 weeks afterwards, in either control or single-session groups. Total cost per patient for single-session administration was 354.63€; for patients receiving IFX and FCM on separate days, it was 531.94€, giving a 177.31€ per-patient cost saving.
  
  
  CONCLUSIONS
  Single-session administration of FCM after IFX was safe and effective in IBD patients and can offer a good cost-benefit ratio and improve treatment adherence. To our knowledge, this study is the first to evaluate FCM and IFX administration in a single treatment session.
authors.affiliation: IBD Unit, Gastroenterology Section, Internal Medicine Hospital of Sagunto, Sagunto, Spain; University of Cardenal Herrera-CEU, Castellón, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Cortes
authors.affiliation: Pharmacy Service, Hospital of Sagunto, Sagunto, Spain.
authors.forename: Joaquín
authors.initials: J
authors.lastname: Borrás-Blasco
authors.affiliation: IBD Unit, Gastroenterology Section, Internal Medicine Hospital of Sagunto, Sagunto, Spain.
authors.forename: Jose Ramón
authors.initials: JR
authors.lastname: Molés
authors.affiliation: IBD Unit, Gastroenterology Department of the University Clinic Hospital of Valencia, Valencia, Spain.
authors.forename: Maia
authors.initials: M
authors.lastname: Boscá
authors.affiliation: Pharmacology, Paediatrics and Organic Chemistry Department, Miguel Hernández University, San Juan of Alicante, Spain.
authors.forename: Ernesto
authors.initials: E
authors.lastname: Cortés
mesh_terms: D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy*; D003362:Cost-Benefit Analysis; D004334:Drug Administration Schedule; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000150:complications / Q000188:drug therapy*; D000069285:Infliximab / Q000008:administration & dosage* / Q000627:therapeutic use; D007262:Infusions, Intravenous / Q000191:economics; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008875:Middle Aged; D010349:Patient Compliance; D010865:Pilot Projects; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D005290:Ferric Compounds; D005765:Gastrointestinal Agents; C522335:ferric carboxymaltose; D008320:Maltose; D000069285:Infliximab