TY - JOUR T1 - Integrated safety across six clinical trials of alpha-1 augmentation therapy JF - European Respiratory Journal JO - Eur Respir J VL - 44 IS - Suppl 58 SP - P950 AU - Robert Sandhaus AU - Kenneth R. Chapman AU - Jonathan Burdon AU - Eeva Piitulainen AU - Niels Seersholm AU - James Stocks AU - Jonathan Edelman AU - Martin Bexon AU - Liping Huang AU - N. Gerard McElvaney Y1 - 2014/09/01 UR - http://erj.ersjournals.com/content/44/Suppl_58/P950.abstract N2 - BackgroundAugmentation therapy with alpha-1 proteinase inhibitor (A1-PI) slows emphysema progression in A1-PI-deficient patients.AimThis 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.ResultsOverall, 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.View this table:Safety across six clinical studies of A1-PI therapyConclusionsThe AE profile of highly purified A1-PI Z is similar to placebo. ER -