Inhibitor development for patients with low and high genetic risk, by product class
| . | pdFVIII . | rFVIII . | NNH . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| No. per group . | Inhibitor count . | Cumulative incidence, % . | 95% CI, % . | No. per group . | Inhibitor count . | Cumulative incidence, % . | 95% CI, % . | ||
| All inhibitors | |||||||||
| Low risk | 16 | 0 | 0 | 0-21 | 22 | 7 | 43 | 23-71 | 2.3 |
| High risk | 101 | 27 | 31 | 22-41 | 96 | 38 | 47 | 36-58 | 6.3 |
| High-titer inhibitors | |||||||||
| Low risk | 16 | 0 | 0 | 0-21 | 22 | 4 | 24 | 10-52 | 4.1 |
| High risk | 101 | 19 | 22 | 14-32 | 96 | 25 | 30 | 21-42 | 11.6 |
| . | pdFVIII . | rFVIII . | NNH . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| No. per group . | Inhibitor count . | Cumulative incidence, % . | 95% CI, % . | No. per group . | Inhibitor count . | Cumulative incidence, % . | 95% CI, % . | ||
| All inhibitors | |||||||||
| Low risk | 16 | 0 | 0 | 0-21 | 22 | 7 | 43 | 23-71 | 2.3 |
| High risk | 101 | 27 | 31 | 22-41 | 96 | 38 | 47 | 36-58 | 6.3 |
| High-titer inhibitors | |||||||||
| Low risk | 16 | 0 | 0 | 0-21 | 22 | 4 | 24 | 10-52 | 4.1 |
| High risk | 101 | 19 | 22 | 14-32 | 96 | 25 | 30 | 21-42 | 11.6 |
For the zero observations in the low-risk pdFVIII group, the 95% CI was based on a binomial distribution, ignoring censoring. Median number of exposure days was 45.4 in the low-risk pdFVIII group, 29 in the low-risk rFVIII group, 15.5 in the high-risk pdFVIII group, and 17.5 in the high-risk rFVIII group.
NNH, number needed to harm when treated with rFVIII instead of pdFVIII.