PURPOSE: To investigate the incidence of pulmonary exacerbations of chronic obstructive pulmonary disease (COPD) in patients with alpha1-proteinase inhibitor (A1-PI) deficiency receiving augmentation therapy with the products Zemaira® (ZLB Behring, Philadelphia, USA) [Z(A1-PI)] and Prolastin® (Talecris Biotherapeutics Inc., North Carolina, USA) [P(A1-PI)].
METHODS: This was a retrospective analysis of COPD exacerbations in a double-blind, controlled clinical study. A total of 44 patients with A1-PI deficiency were randomized to receive Z(A1-PI) 60 mg/kg or P(A1-PI) 60 mg/kg once weekly for 10 weeks. The following adverse events reported by investigators and in patient diaries were considered to be exacerbations of COPD: bronchitis, pneumonia, COPD exacerbation, lower respiratory tract infection, and asthma exacerbation. In addition, patients were required to meet the following American Thoracic Society criteria for pulmonary exacerbations: (a) two of the three primary diagnostic criteria, or (b) one primary and one supporting criterion.
RESULTS: Six out of 30 patients (20%) in the Z(A1-PI) group had a total of 7 exacerbations of COPD, compared with 9 of the 14 patients (64%) in the P(A1-PI) group, who had 11 exacerbations.
CONCLUSION: In this small study, the incidence of COPD exacerbations was less in patients receiving Z(A1-PI) compared with P(A1-PI). This finding should be investigated further in a larger trial.
CLINICAL IMPLICATIONS: Z(A1-PI) as augmentation therapy may result in fewer COPD exacerbations.
DISCLOSURE: Alphonse Hubsch, Employee VR and AH are employees of ZLB Behring.