Table 3.

Multivariate analysis (Cox model) of inhibitor incidence according to risk factors



All inhibitors

High inhibitors

High inhibitors and/or ITI

CII (%)
RRa
95% CI
P
CII*(%)
RRa
95% CI
P
CII (%)
RRa
95% CI
P
Product     .049      .157      .045  
   FVIII-LFB   10.3   1.0   –    5.2   1.0   –    6.9   1.0   –   
   Recombinant FVIII*  32.3   2.4   1.0-5.8    15.0   2.6   0.7-9.6    23.7   3.2   1.0-9.7   
F8 genotype     .085      .710      .251  
   Other mutations   20.9   1.0   –    9.6   1.0   –    14.8   1.0   –   
   High-risk mutations   25.1   2.5   1.1-5.6    11.8   1.6   0.5-5.0    18.7   2.2   0.9-5.9   
   Nonavailable (intron 22 neg.)   20.0   2.1   0.4-10.3    10.0   1.4   0.1-13.1    10.0   1.5   0.2-13.8   
Ethnicity     <.001      .026      <.001  
   White   15.0   1.0   –    7.8   1.0   –    10.5   1.0   –   
   Other   62.8   6.7   2.9-15.3    26.8   3.5   1.2-10.3    47.7   5.6   2.2-13.9   
Family history of inhibitor     .006      .121      .042  
   No   12.4   1.0   –    2.5   1.0   –    7.8   1.0   –   
   Yes   40.0   6.3   1.9-20.8    20.0   10.2   1.1-99.4    27.3   5.8   1.3-27.1   
   No family history of hemophilia   25.1   4.6   1.6-13.3    13.6   7.4   0.9-58.4    18.8   5.0   1.3-18.4   
Age at first infusion     .031      .546      .043  
   Younger than 6 months   38.1   1.0   –    16.0   1.0   –    30.0   1.0   –   
   6 to 11 months   21.3   0.5   0.2-1.3    10.6   0.8   0.2-2.8    12.7   0.4   0.1-1.0   
   12 months or older
 
15.7
 
0.3
 
0.1-0.7
 

 
8.3
 
0.5
 
0.1-1.8
 

 
12.3
 
0.3
 
0.1-0.8
 

 


All inhibitors

High inhibitors

High inhibitors and/or ITI

CII (%)
RRa
95% CI
P
CII*(%)
RRa
95% CI
P
CII (%)
RRa
95% CI
P
Product     .049      .157      .045  
   FVIII-LFB   10.3   1.0   –    5.2   1.0   –    6.9   1.0   –   
   Recombinant FVIII*  32.3   2.4   1.0-5.8    15.0   2.6   0.7-9.6    23.7   3.2   1.0-9.7   
F8 genotype     .085      .710      .251  
   Other mutations   20.9   1.0   –    9.6   1.0   –    14.8   1.0   –   
   High-risk mutations   25.1   2.5   1.1-5.6    11.8   1.6   0.5-5.0    18.7   2.2   0.9-5.9   
   Nonavailable (intron 22 neg.)   20.0   2.1   0.4-10.3    10.0   1.4   0.1-13.1    10.0   1.5   0.2-13.8   
Ethnicity     <.001      .026      <.001  
   White   15.0   1.0   –    7.8   1.0   –    10.5   1.0   –   
   Other   62.8   6.7   2.9-15.3    26.8   3.5   1.2-10.3    47.7   5.6   2.2-13.9   
Family history of inhibitor     .006      .121      .042  
   No   12.4   1.0   –    2.5   1.0   –    7.8   1.0   –   
   Yes   40.0   6.3   1.9-20.8    20.0   10.2   1.1-99.4    27.3   5.8   1.3-27.1   
   No family history of hemophilia   25.1   4.6   1.6-13.3    13.6   7.4   0.9-58.4    18.8   5.0   1.3-18.4   
Age at first infusion     .031      .546      .043  
   Younger than 6 months   38.1   1.0   –    16.0   1.0   –    30.0   1.0   –   
   6 to 11 months   21.3   0.5   0.2-1.3    10.6   0.8   0.2-2.8    12.7   0.4   0.1-1.0   
   12 months or older
 
15.7
 
0.3
 
0.1-0.7
 

 
8.3
 
0.5
 
0.1-1.8
 

 
12.3
 
0.3
 
0.1-0.8
 

 

CII indicates cumulative incidence of inhibitor at 50 CEDs; –, not applicable.

*

Recombinate (n = 62) or Kogenate (n = 24)

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