Table 2.
Comparison between different densitometric parameters (whole lung CT scans) to assess progression of emphysema in patients treated with Prolastin versus placebo (mITT population)
| PD15 (g/L) | Prolastin (n = 36) |
Placebo (n = 35) |
| Change from baseline to last CT scan (mean ± SD) | -2.895 ± 4.739 | -4.124 ± 4.147 |
| Change from baseline to last CT scan (LS mean [SE]) | -2.645 (0.526) < 0.0001a |
-4.117 (0.539) < 0.0001a |
| Estimated treatment difference between LS mean changes from baseline (95% CI) | 1.472 (0.009, 2.935) | |
| p value for treatment differenceb | 0.049 | |
| MLD (g/L) | Prolastin (n = 36) |
Placebo (n = 35) |
| Change from baseline to last CT scan (mean ± SD) | -2.115 ± 7.937 | -3.289 ± 5.949 |
| Change from baseline to last CT scan (LS mean [SE]) | -1.911 (0.788) 0.0181a |
-3.313 (0.801) 0.0001a |
| Estimated treatment difference between LS mean changes from baseline (95% CI) | 1.402 (-0.782, 3.586) |
|
| p value for treatment differenceb | 0.204 | |
| VI-910 (%) | Prolastin (n = 36) |
Placebo (n = 35) |
| Change from baseline to last CT scan (mean ± SD) | 1.761 ± 4.511 | 2.209 ± 3.378 |
| Change from baseline to last CT scan (LS mean [SE]) | 1.643 (0.508) 0.0019a |
2.254 (0.517) < 0.0001a |
| Estimated treatment difference between LS mean changes from baseline (95% CI) | -0.611 (-2.019, 0.797) |
|
| p value for treatment differenceb | 0.389 | |
| VI-950 (%) | Prolastin (n = 36) |
Placebo (n = 35) |
| Change from baseline to last CT scan (mean ± SD) | 1.994 ± 3.307 | 2.315 ± 2.578 |
| Change from baseline to last CT scan (LS mean [SE]) | 1.924 (0.411) < 0.0001a |
2.356 (0.420) < 0.0001a |
| Estimated treatment difference between LS mean changes from baseline (95% CI) | -0.432 (-1.573, 0.709) |
|
| p value for treatment differenceb | 0.452 | |
PD15, 15th percentile lung density; CT, computed tomography; SD, standard deviation; LS mean, least squares mean; SE, standard error; 95% CI, 95% confidence interval; MLD, mean lung density; VI-910, voxel index at a threshold of -910 (measured in %); VI-950, voxel index at a threshold of -950 (measured in %). ap values are for the comparison of change from baseline to last CT scan versus no change from baseline within the individual treatment groups. bProlastin treatment minus placebo (LS mean change).