Abstract
Background
Augmentation therapy with alpha-1 proteinase inhibitor (A1-PI) slows emphysema progression in A1-PI-deficient patients.
Aim
This integrated safety summary assessed rates of adverse events (AEs) across six clinical studies of intravenous A1-PI Z (Zemaira®, CSL Behring).
Methods
The data set includes RAPID (NCT00261833), the single largest clinical trial of A1-PI augmentation therapy, its ongoing extension study (NCT00670007), and four smaller trials.
Results
Overall, the incidence of AEs with A1-PI Z was not higher than with placebo; most AEs were linked to patients' respiratory conditions. The most common related AEs were headache and dizziness. Six patients died during the studies; none was considered treatment-related. There were five serious AEs judged by the investigators to be at least possibly related to A1-PI Z (enterocolitis, pancreatitis, 'adverse drug reaction', back pain, pulmonary fibrosis) and one with placebo (musculoskeletal chest pain). There was no A1-PI antibody formation or viral transmission.
Conclusions
The AE profile of highly purified A1-PI Z is similar to placebo.
- © 2014 ERS