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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)

From: Exploring the optimum approach to the use of CT densitometry in a randomised placebo-controlled study of augmentation therapy in alpha 1-antitrypsin deficiency

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
  1. 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).