Table 1.

Summary of clinical studies evaluating FVIII IVR stratified by BMI

ReferenceStudy design (age, years)nIntervention (median IU, range)BMI groups (kg/m2) (n)IVR (IU dL−1/IU kg−1)Strongest predictor of IVR
Henrard et al5  Prospective observational (mean, 40.4 ± 12.3) 46 A dose of rFVIII (2000, 980-4200) 18.5-24.9 (26)
25.0-29.9 (14)
≥30.0 (6) 		1.88
2.30
2.70 		BW 
Henrard et al6  Retrospective pooled analysis of 8 PK trials (median, 26; IQR, 21-38) 201 A dose of rFVIII (3745, 1953-8794) <18.5 (9)
18.5-24.9 (105)
25.0-29.9 (52)
>30.0 (35) 		1.72
2.03
2.18
2.68 		BMI 
Henrard et al7  Retrospective pool analysis of 6 PK trials (median, 14.5; IQR, 12.8-15.6)a 66 A dose of rFVIII (2778, 1675-5420) Normal (43)
Overweight (7)
Obese (16)b 		1.93
2.12
2.65 		BMI-for-age 
Tiede et al8  Prospective observational (mean, 37.4; range, 23.0–57.0) 35 rFVIII 50 IU/kg by ABW <18.5 (5)
18.5-24.9 (7)
25.0-29.9 (9)
30.0-34.9 (7)
≥35 (7) 		2.2c
2.9c
2.9c
3.2c
3.5c 		BMI 
ReferenceStudy design (age, years)nIntervention (median IU, range)BMI groups (kg/m2) (n)IVR (IU dL−1/IU kg−1)Strongest predictor of IVR
Henrard et al5  Prospective observational (mean, 40.4 ± 12.3) 46 A dose of rFVIII (2000, 980-4200) 18.5-24.9 (26)
25.0-29.9 (14)
≥30.0 (6) 		1.88
2.30
2.70 		BW 
Henrard et al6  Retrospective pooled analysis of 8 PK trials (median, 26; IQR, 21-38) 201 A dose of rFVIII (3745, 1953-8794) <18.5 (9)
18.5-24.9 (105)
25.0-29.9 (52)
>30.0 (35) 		1.72
2.03
2.18
2.68 		BMI 
Henrard et al7  Retrospective pool analysis of 6 PK trials (median, 14.5; IQR, 12.8-15.6)a 66 A dose of rFVIII (2778, 1675-5420) Normal (43)
Overweight (7)
Obese (16)b 		1.93
2.12
2.65 		BMI-for-age 
Tiede et al8  Prospective observational (mean, 37.4; range, 23.0–57.0) 35 rFVIII 50 IU/kg by ABW <18.5 (5)
18.5-24.9 (7)
25.0-29.9 (9)
30.0-34.9 (7)
≥35 (7) 		2.2c
2.9c
2.9c
3.2c
3.5c 		BMI 
a

Only trial in children.

b

Based on the BMI-for-age percentiles (normal, 5th-84th; overweight, 85th-94th; obese, >95th).

c

End point reported as IVR at 30 minutes using a geometric mean.

IQR, interquartile range.

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