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)