"In the study, the incidence of chronic obstructive pulmonary disease exacerbations was lower in patients receiving Zemaira compared with those receiving the control drug, Prolastin," said investigator Val Romberg, BS, clinical researcher, ZLB Behring, King of Prussia, Pennsylvania.

Romberg, in his poster presentation on October 25^th, identified 44 patients who participated in the 10-week, double-blind study comparing the 2 agents. Thirty patients were treated with Zemaira in that phase of the study and 7 exacerbations occurred in 6 patients -- 20% of the total number of patients. There were 14 patients on Prolastin and 11 exacerbations occurred in 9 of those patients -- 54% of the total.

In the open-label phase, which lasted from week 11 through week 24, all 44 patients were on Zemaira. There were 4 exacerbations in 3 patients who were in the original Zemaira group -- 10% of the original total. Five patients of the 14 patients switched to Zemaira had 6 exacerbations -- 36% of the original Prolastin group.

Overall, 12 of the 44 patients treated with Zemaira had 17 exacerbations by the end of the trial -- about 27% of the total, Romberg said.

"Exacerbations of chronic obstructive pulmonary disease occur frequently in patients with alpha1-antitrypsin deficiency and associated moderate to severe chronic obstructive pulmonary disease," he said. "They are associated with significantly worsening health status."

The post hoc analysis of the study was conducted to investigate the incidence of exacerbations for the purpose of generating further study hypotheses, therefore, statistical significance calculations were not performed.

However, Romberg said, "The effect of anlpha-1-antitrypsin deficiency augmentation therapy on the frequency and severity of chronic obstructive pulmonary disease exacerbations and potential differences between alpha1-antitrypsin proteinase inhibitor products should be further investigated."

ZLB Behring supported the study.


[Presentation title: Retrospective Analysis of COPD Exacerbations in Patients Treated With Alpha1-Proteinase Inhibitor Augmentation Therapy. Abstract 4021]

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