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Integrated Analysis Demonstrates Alpha(1)-Augmentation Therapy Significantly Reduces Loss of Lung Tissue in Patients with AAT-deficiency-related Emphysema
Date:11/15/2010

for the AAT treatment group and -6.379g/L for the placebo group, a statistically significant difference of 2.297 (95% CI, 0.669 to 3.926; p = 0.006).

"The mean data from the integrated analysis demonstrate a deceleration of lung tissue loss with AAT augmentation therapy versus placebo with statistical significance," said Stockley.

The effect of augmentation therapy with any Alpha(1)-proteinase inhibitor (A1PI) on pulmonary exacerbations and on the progression of emphysema in Alpha(1)-antitrypsin deficiency has not been demonstrated in a single, prospective, randomized, controlled clinical trial.

The two clinical trials included in the integrated analysis were a three-year Danish-Dutch study of 56 patients (http://ajrccm.atsjournals.org/cgi/content/full/160/5/1468) and the EXAcerbations and CT scan as Lung Endpoints (EXACTLE) trial of 77 patients over 24 to 30 months (http://erj.ersjournals.com/content/33/6/1345.full).  In both trials, patients were randomized to receive infusions of A1PI or a placebo.  The results suggested a trend toward reduction in emphysema progression with A1PI therapy, as measured by CT densitometry. The trials were not powered to show efficacy; thus neither trial reached statistical significance on its own. Pooling the data increased the number of patients and the statistical power of the analysis.

Talecris Biotherapeutics, manufacturer of PROLASTIN®-C (Alpha(1)-Proteinase Inhibitor [Human]), funded the integrated analysis and the EXACTLE trial included in the analysis.

About PROLASTIN®-C

PROLASTIN-C is indicated for chronic augmentation and maintenance therapy in Alpha(1)-antitrypsin (AAT) deficiency in patients with emphysema.  AAT deficiency is a genetic condition in which low level
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SOURCE Talecris Biotherapeutics
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