Table 1.
Observed baseline characteristics of patients treated with BAY 94-9027 and rFVIIIFc, before and after matching
Baseline characteristicsb | Before matching | After matchinga | ||||
---|---|---|---|---|---|---|
BAY 94-9027 | rFVIIIFc | P | BAY 94-9027 | rFVIIIFc | P | |
N=103 | N=140 | N=103 | N=140 | |||
Age ≤29.4 years | 33 (32.0%) | 70 (50.0%) | <0.01* | 50.0% | 50.0% | 1.00 |
Weight ≤72.4 kg | 49 (47.6%) | 70 (50.0%) | 0.81 | 50.0% | 50.0% | 1.00 |
Ethnicity | ||||||
White | 73 (70.9%) | 90 (64.1%) | 0.35 | 64.1% | 64.1% | 1.00 |
Asian | 26 (25.2%) | 38 (26.8%) | 0.85 | 26.8% | 26.8% | 1.00 |
Region | ||||||
Europe | 37 (35.9%) | 37 (26.1%) | 0.15 | 26.1% | 26.1% | 1.00 |
North America | 23 (22.3%) | 48 (34.5%) | 0.06 | 34.5% | 34.5% | 1.00 |
Prior treatment type | ||||||
Prophylactic | 83 (80.6%) | 86 (61.3%) | <0.01* | 61.3% | 61.3% | 1.00 |
On-demand | 20 (19.4%) | 54 (38.7%) | <0.01* | 38.7% | 38.7% | 1.00 |
Number of bleeding events in the prior year | ||||||
Prior prophylactic: >6.0 | 31 (30.1%) | 43 (30.6%) | 1.00 | 30.6% | 30.6% | 1.00 |
Prior on-demand: >27.4 | 14 (13.6%) | 27 (19.4%) | 0.32 | 19.4% | 19.4% | 1.00 |
Presence of target joint(s) | ||||||
Prior prophylactic | 61 (59.2%) | 46 (33.1%) | <0.001* | 33.1% | 33.1% | 1.00 |
Prior on-demand | 16 (15.5%) | 47 (33.8%) | <0.01* | 33.8% | 33.8% | 1.00 |
Notes: aThe effective sample size of the BAY 94-9027 overall group after matching was 44.60. bThe median of age, weight, and estimated bleeding events in the prior year in the pooled rFVIIIFc group was approximated using the weighted sum of corresponding medians in the individualized and the weekly prophylaxis arms in A-LONG. *P<0.05.
Abbreviation: rFVIIIFc, recombinant human factor VIII–Fc fusion protein.