PMID- 24720694
OWN - NLM
STAT- MEDLINE
DCOM- 20150518
LR  - 20140829
IS  - 1365-2516 (Electronic)
IS  - 1351-8216 (Linking)
VI  - 20
IP  - 5
DP  - 2014 Sep
TI  - Safe switching from a pdFIX (Immunine(R)) to a rFIX (Bax326).
PG  - 674-81
LID - 10.1111/hae.12444 [doi]
AB  - The ability to switch between coagulation factors safely is of common interest to 
      haemophilia patients and treating physicians. This is the first formal 
      prospective comparative evaluation of safety, efficacy and incremental recovery 
      of a plasma-derived FIX (pdFIX) and a recombinant FIX (rFIX) in the same 
      haemophilia B patients following a switch from pdFIX Immunine(R) to a recently 
      developed rFIX Bax326 product. Patients (aged <65 years) who completed a 
      pretreatment study which prospectively documented the exposure to Immunine(R) and 
      monitored FIX inhibitors while receiving prophylactic treatment were transitioned 
      into pivotal (patients aged 12-65 years) and paediatric (patients aged <12 years) 
      clinical studies investigating prophylaxis and treatment of bleeding episodes 
      with Bax326. None of the 44 patients developed inhibitory or specific binding 
      anti-FIX antibodies during the course of the studies. A total of 38 unrelated 
      adverse events (AEs) were occurred in 20/44 (45.5%) subjects during the Immunine(R) 
      study. Following a switch to Bax326, 51 AEs were reported in 25/44 (56.8%) 
      subjects. The incidence of AEs related to Bax326 treatment (two episodes of 
      dysgeusia in one patient) was low (2.3%); there were no serious adverse 
      reactions. The comparison between Immunine(R) and Bax326 demonstrated analogous 
      haemostatic characteristics and annualized bleeding rates. Overall, there is 
      direct evidence indicating a safe and clinically effective transition from a 
      pdFIX (Immunine(R)) to a newly developed rFIX (Bax326(1) ) for prophylaxis and 
      treatment of bleeding in previously treated patients of all age cohorts with 
      severe or moderately severe haemophilia B.
CI  - (c) 2014 John Wiley & Sons Ltd.
FAU - Solano Trujillo, M H
AU  - Solano Trujillo MH
AD  - Hospital de San Jose FUCS, Bogota, Colombia.
FAU - Stasyshyn, O
AU  - Stasyshyn O
FAU - Rusen, L
AU  - Rusen L
FAU - Serban, M
AU  - Serban M
FAU - Lamas, J L
AU  - Lamas JL
FAU - Perina, F G
AU  - Perina FG
FAU - Urasinski, T
AU  - Urasinski T
FAU - Oh, M
AU  - Oh M
FAU - Knowlton, W B
AU  - Knowlton WB
FAU - Valenta-Singer, B
AU  - Valenta-Singer B
FAU - Pavlova, B G
AU  - Pavlova BG
FAU - Abbuehl, B
AU  - Abbuehl B
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20140410
PL  - England
TA  - Haemophilia
JT  - Haemophilia : the official journal of the World Federation of Hemophilia
JID - 9442916
RN  - 0 (Blood Coagulation Factor Inhibitors)
RN  - 0 (Coagulants)
RN  - 0 (Recombinant Proteins)
RN  - 9001-28-9 (Factor IX)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Blood Coagulation/drug effects
MH  - Blood Coagulation Factor Inhibitors/blood
MH  - Child
MH  - Coagulants/adverse effects/pharmacokinetics/*therapeutic use
MH  - Cross-Over Studies
MH  - Drug Substitution/*standards
MH  - Factor IX/adverse effects/*therapeutic use
MH  - Female
MH  - Hemophilia B/*drug therapy/immunology
MH  - Hemorrhage/epidemiology
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Recombinant Proteins/adverse effects/pharmacokinetics/*therapeutic use
MH  - Young Adult
OTO - NOTNLM
OT  - haemophilia B
OT  - pdFIX (Immunine(R))
OT  - previously treated patients
OT  - rFIX (Rixubis(R))
OT  - safety
EDAT- 2014/04/12 06:00
MHDA- 2015/05/20 06:00
CRDT- 2014/04/12 06:00
PHST- 2014/01/24 00:00 [received]
PHST- 2014/03/19 00:00 [accepted]
PHST- 2014/04/12 06:00 [entrez]
PHST- 2014/04/12 06:00 [pubmed]
PHST- 2015/05/20 06:00 [medline]
AID - 10.1111/hae.12444 [doi]
PST - ppublish
SO  - Haemophilia. 2014 Sep;20(5):674-81. doi: 10.1111/hae.12444. Epub 2014 Apr 10.