Safe switching from a pdFIX (Immunine®) to a rFIX (Bax326).
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® to a recently developed rFIX Bax326 product. Patients (aged <65 years) who completed a pretreatment study which prospectively documented the exposure to Immunine® 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® 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® 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®) 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.
Hospital de San Jose FUCS, Bogotá, Colombia.
M H
MH
Solano Trujillo
O
O
Stasyshyn
L
L
Rusen
M
M
Serban
J L
JL
Lamas
F G
FG
Perina
T
T
Urasinski
M
M
Oh
W B
WB
Knowlton
B
B
Valenta-Singer
B G
BG
Pavlova
B
B
Abbuehl
D000293:Adolescent; D000328:Adult; D001777:Blood Coagulation / Q000187:drug effects; D019774:Blood Coagulation Factor Inhibitors / Q000097:blood; D002648:Child; D003029:Coagulants / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D018592:Cross-Over Studies; D057915:Drug Substitution / Q000592:standards*; D005164:Factor IX / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D002836:Hemophilia B / Q000188:drug therapy* / Q000276:immunology; D006470:Hemorrhage / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D055815:Young Adult
D019774:Blood Coagulation Factor Inhibitors; D003029:Coagulants; D011994:Recombinant Proteins; D005164:Factor IX
haemophilia B; pdFIX (Immunine®); previously treated patients; rFIX (Rixubis®); safety