TABLE 4.
ADA‐negative PwHA (N = 634) | ADA‐positive PwHA b (N = 30) | ADA‐positive PwHA with decreased exposure (N = 4) | |
---|---|---|---|
Duration of efficacy period Median [IQR], weeks |
103 [84‐150] |
103 [78‐160] |
57 c [16; 65; 80; 50] |
Annualised rate of treated bleeding events Model‐based d [95% CI] |
.9 [.79‐1.11] |
.7 [.37‐1.33] |
14.1 c [23.0; 28.0; 0; 5.3] |
Proportion of participants with zero treated bleeds, n (%) [95% CI e ] |
374 (59.0) [55.1‐62.9] |
16 (53.3) [34.3‐71.7] |
1 (25.0) [.6‐80.6] |
Annualised rate of all bleeding events Model‐based d [95% CI] |
2.3 [1.99‐2.60] |
1.2 [.75‐1.91] |
15.2 c [23.0; 28.0; 0; 7.4] |
Proportion of participants with zero all bleeds n (%) [95% CI e ] |
224 (35.3) [31.6‐39.2] |
7 (23.3) [9.9‐42.3] |
1 (25.0) [.6‐80.6] |
Abbreviations: ABR, annualised bleed rate; ADA, anti‐drug antibody; CI, confidence interval; IQR, interquartile range; PwHA, persons with haemophilia A.
Data includes the up‐titration period.
Excluding participants A, B, C, and D with ADA with decreased exposure.
Median [individual data for participants A, B, C, and D, respectively] (Figures S1–S4).
Model‐based ABR were derived using a negative‐binomial regression model.
CIs were derived using the exact method.