Clinical Study

Risk Factors for High-Titer Inhibitor Development in Children with Hemophilia A: Results of a Cohort Study

Table 2

(a) Univariate analyses. Odds ratios (ORs) and 95% confidence intervals (CIs) are shown. (b) Multivariate analysis (Cox proportional-hazards regression). Adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) are shown.
(a)

Parameter investigatedOdds ratio (95% CIs)

Comparator pdFVIII *
First generation rFVIII (all products)1.24 (0.54–2.84)
 CHO; full-length, human albumin0.9 (0.39–2.19)
 BHK; full-length; human albumin1.07 (0.45–2.53)
Second generation rFVIII (all products)2.98 (1.71–5.20)
 BHK; full-length sucrose6.26 (3.14–12.4)
 CHO; B-domain deleted2.83 (0.88–9.07)
Comparator 1 IU/kg bw
Median single FVIII dose increase per one IU/kg bw1.07 (1.05–1.09)
Comparator “late” FVIII administration versus
“early” FVIII administration 3.17 (1.83–5.51)
Comparator: intensified treatment moments “absent”
Intensified treatment moments present2.86 (1.18–6.96)
Comparator : risk gene mutation “absent”
High risk gene mutation present5.45 (3.04–9.76)
Comparator “year of birth” 1 year
Increase per birth year 1.10 (1.06–1.15)

kg bw: kilogram bodyweight; *exclusion of 23 Israeli children (RODIN overlap).
(b)

Parameter investigatedHazard ratios (95% CIs)

Comparator pdFVIII/first generation FVIII
Second generation rFVIII 1.37 (0.7–2.68)
Comparator 1 IU/kg bw
Median single FVIII dose increase per one IU/kg bw1.05 (1.04–1.07)
Comparator “late” FVIII administration versus
“early” FVIII administration 1.97 (1.15–3.4)
Comparator: intensified treatment moments “absent”
Intensified treatment moments present1.19 (0.58–2.45)
Comparator: risk gene mutation “absent”
High risk gene mutation present2.37 (1.40–3.99)
Comparator “year of birth” 1 year
Increase per birth year 1.08 (1.03–1.13)

kg bw: kilogram bodyweight.