0
Abstract: Poster Presentations |

ASSESSMENT OF A NEW ALPHA1-ANTITRYPSIN REPLACEMENT THERAPY IN TWO MULTIPLE-DOSE STUDIES: SAFETY AND TOLERABILITY FREE TO VIEW

Friedrich Kueppers, MD*; James M. Stocks, MD; Mark Brantly, MD; David Pollock, BS; Alan Barker, MD; Charlie Strange, MD; James F. Donohue, MD; Robert Sandhaus, MD
Author and Funding Information

Temple University Hospital, Philadelphia, PA



Chest. 2006;130(4_MeetingAbstracts):182S. doi:10.1378/chest.130.4_MeetingAbstracts.182S-c
Text Size: A A A
Published online

Abstract

PURPOSE: To evaluate the safety and tolerability of Zemaira® (ZLB Behring LLC) [Z(A1-PI)] in two multiple-dose studies of patients with alpha1-antitrypsin deficiency.

METHODS: The two investigations comprised: (A) a 26-week multicenter, open-label study of weekly intravenous infusions of Z(A1-PI) 60 mg/kg (n=9); and (B) a 24-week multicenter, controlled study in 43 patients randomized 2:1 to Z(A1-PI) or an active control preparation (Talecris Biotherapeutics) [P(A1 PI)] 60 mg/kg given by weekly intravenous infusions. Adverse events (AEs), rated as mild, moderate or severe, AE rates per infusion, and relationship of AE to study medication, were recorded.

RESULTS: Fifty-two patients (35 male, 17 female; mean age 51, SD 8 years), received a total of 1259 infusions of Z(A1-PI). In study B, 14 subjects received a total of 142 infusions of P(A1-PI). All patients presented with alpha1-antitrypsin deficiency (mean A1-PI level at screening: 6.0 μM, SD 1.5 μM) and emphysema. Fourteen (100%) of P(A1-PI)- and 50 (96%) of Z(A1-PI)-treated subjects reported at least 1 treatment-emergent AE. In 1259 infusions of Z(A1-PI), there were 254 AEs [0.202 AEs per infusion]; 73 AEs occurred in 142 infusions of P(A1-PI) [0.514 per infusion]. Only 3 AEs in each group were considered related to study drug [Z(A1-PI) 0.003 related AEs per infusion; P(A1-PI) 0.021 related AEs per infusion]. The majority of AEs were either mild or moderate in severity. No treatment-related serious AEs were reported in either study.

CONCLUSION: Z(A1-PI) is safe and well-tolerated. There was no significant difference in the number and severity of AEs between the infusions of the two preparations.

CLINICAL IMPLICATIONS: Z(A1-PI) is suitable for augmentation therapy in patients with alpha1-antitrypsin deficiency.

DISCLOSURE: Friedrich Kueppers, Grant monies (from industry related sources) FK has received funding from the Arlene Meth Fund, Baxter, and ZLB Behring; Other This research was funded by ZLB Behring LLC.

Wednesday, October 25, 2006

12:30 PM - 2:00 PM


Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543