For Healthcare ProfessionalsIntended for US Audiences


A low risk of inhibitor development in previously treated patients (PTPs)*4-8

Incidence of inhibitors
ADVATE [Antihemophilic Factor (Recombinant)] in 6 clinical studies, 270 patients had a .37% incidence of inhibitors. (95% confidence interval, 0.02% - 2.13%)
Learn about the safety profile of ADVATE [Antihemophilic Factor (Recombinant)]: 1 low-titer, nonpersistent inhibitor (<1%) in the pivotal study (n=108)  ref a, b, 6 0 inhibitors in a continuation study (n=82)  ref a, b, 5 0 inhibitors in a pediatric study (n=53)  ref c, 8 0 inhibitors in a surgery study (n=59)  ref a, b, 7 0 inhibitors in a Japanese study (n=15)  ref 5 0 inhibitors in a prophylaxis study (n=73)  ref a, d, 4

*PTPs are considered to be the most appropriate study population for the assessment of product-related immunogenicity.13 Six clinical studies of 270 PTPs with moderately severe to severe hemophilia A demonstrated a low inhibitor rate of 0.37%.4-8

aPatients with an estimated ≤150 factor VIII exposure days.4,6,7

bSome patients participated in more than 1 study.5

cPatients with an estimated ≤50 factor VIII exposure days.8

dThere was 1 case of a possible low-titer factor VIII inhibitor, which was unconfirmed, unaccompanied by symptoms of inhibitor presence, and disappeared at the subject’s subsequent test.4