PMID- 26011514
OWN - NLM
STAT- MEDLINE
DCOM- 20160427
LR  - 20220311
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 10
IP  - 5
DP  - 2015
TI  - Safety of ferric carboxymaltose immediately after infliximab administration, in a 
      single session, in inflammatory bowel disease patients with iron deficiency: a 
      pilot study.
PG  - e0128156
LID - 10.1371/journal.pone.0128156 [doi]
LID - e0128156
AB  - AIM: 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 354.63euro; for patients receiving 
      IFX and FCM on separate days, it was 531.94euro, giving a 177.31euro per-patient cost 
      saving. CONCLUSION: 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.
FAU - Cortes, Xavier
AU  - Cortes X
AD  - IBD Unit, Gastroenterology Section, Internal Medicine Hospital of Sagunto, 
      Sagunto, Spain; University of Cardenal Herrera-CEU, Castellon, Spain.
FAU - Borras-Blasco, Joaquin
AU  - Borras-Blasco J
AD  - Pharmacy Service, Hospital of Sagunto, Sagunto, Spain.
FAU - Moles, Jose Ramon
AU  - Moles JR
AD  - IBD Unit, Gastroenterology Section, Internal Medicine Hospital of Sagunto, 
      Sagunto, Spain.
FAU - Bosca, Maia
AU  - Bosca M
AD  - IBD Unit, Gastroenterology Department of the University Clinic Hospital of 
      Valencia, Valencia, Spain.
FAU - Cortes, Ernesto
AU  - Cortes E
AD  - Pharmacology, Paediatrics and Organic Chemistry Department, Miguel Hernandez 
      University, San Juan of Alicante, Spain.
LA  - eng
PT  - Clinical Study
PT  - Journal Article
PT  - Observational Study
DEP - 20150526
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Ferric Compounds)
RN  - 0 (Gastrointestinal Agents)
RN  - 6897GXD6OE (ferric carboxymaltose)
RN  - 69-79-4 (Maltose)
RN  - B72HH48FLU (Infliximab)
SB  - IM
MH  - Adult
MH  - Anemia, Iron-Deficiency/*drug therapy
MH  - Cost-Benefit Analysis
MH  - Drug Administration Schedule
MH  - Ferric Compounds/*administration & dosage/adverse effects
MH  - Gastrointestinal Agents/*administration & dosage/therapeutic use
MH  - Humans
MH  - Inflammatory Bowel Diseases/complications/*drug therapy
MH  - Infliximab/*administration & dosage/therapeutic use
MH  - Infusions, Intravenous/economics
MH  - Male
MH  - Maltose/administration & dosage/adverse effects/*analogs & derivatives
MH  - Middle Aged
MH  - Patient Compliance
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Treatment Outcome
PMC - PMC4443970
COIS- Competing Interests: The authors have declared that no competing interests exist.
EDAT- 2015/05/27 06:00
MHDA- 2016/04/28 06:00
PMCR- 2015/05/26
CRDT- 2015/05/27 06:00
PHST- 2015/02/03 00:00 [received]
PHST- 2015/04/22 00:00 [accepted]
PHST- 2015/05/27 06:00 [entrez]
PHST- 2015/05/27 06:00 [pubmed]
PHST- 2016/04/28 06:00 [medline]
PHST- 2015/05/26 00:00 [pmc-release]
AID - PONE-D-15-02072 [pii]
AID - 10.1371/journal.pone.0128156 [doi]
PST - epublish
SO  - PLoS One. 2015 May 26;10(5):e0128156. doi: 10.1371/journal.pone.0128156. 
      eCollection 2015.