Table 1

Relative rate of developing inhibitory antibodies against factor VIII in severe hemophilia A patients receiving recombinant factor VIII products as compared to plasma-derived factor VIII products

RR (95% CI)
All patients* N=322 
    Crude relative rate 1.0 (0.5-1.7) 
    Adjusted relative rate 1.2 (0.7-2.1) 
Exposure days on Beriate excluded  
    Crude relative rate 0.9 (0.5-1.6) 
    Adjusted relative rate 1.1 (0.6-2.0) 
Exposure days after switch of product excluded  
    Crude relative rate 1.3 (0.7-2.4) 
    Adjusted relative rate 1.5 (0.8-3.0) 
Beriate and postswitch exposure days excluded  
    Crude relative rate 1.3 (0.6-2.7) 
    Adjusted relative rate 1.4 (0.6-2.9) 
RR (95% CI)
All patients* N=322 
    Crude relative rate 1.0 (0.5-1.7) 
    Adjusted relative rate 1.2 (0.7-2.1) 
Exposure days on Beriate excluded  
    Crude relative rate 0.9 (0.5-1.6) 
    Adjusted relative rate 1.1 (0.6-2.0) 
Exposure days after switch of product excluded  
    Crude relative rate 1.3 (0.7-2.4) 
    Adjusted relative rate 1.5 (0.8-3.0) 
Beriate and postswitch exposure days excluded  
    Crude relative rate 1.3 (0.6-2.7) 
    Adjusted relative rate 1.4 (0.6-2.9) 
*

For recombinant F VIII compared with plasma-derived products with high VWF content.

High von Willebrand factor concentration was defined as more than 0.01 IU VWF antigen per IU factor VIII antigen.

RR indicates relative rate; CI, confidence interval; and VWF, von Willebrand factor.

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