Multi-center study: The biochemical efficacy, safety and tolerability of a new α1-proteinase inhibitor, Zemaira

James M. Stocks, Mark Brantly, David Pollock, Alan Barker, Friedrich Kueppers, Charlie Strange, James F. Donohue, Robert Sandhaus

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

Augmentation therapy with a plasma derived α1-Proteinase Inhibitor (α1-PI) has been demonstrated to be effective in restoring serum Alpha1-antitrypsin (AAT)* levels in individuals with AAT Deficiency (note: α1 PI and AAT are synonymous). The objective of this study was to demonstrate that the steady-state trough serum α1-PI levels, achieved by a new plasma derived α1-PI (Zemaira, study drug, ZLB Behring LLC, King of Prussia, Pennsylvania, USA), were bioequivalent to those achieved by the currently available α1-PI therapy, Prolastin (control drug, Bayer Corporation, Berkeley, California, USA), and maintained weekly trough serum antigenic α1-PI levels above the protective threshold of 11 μM. This multi-center, controlled study randomized a total of 44 subjects to receive either study or control drug for a 10-week double-blind phase. The control group was then crossed over to receive the study drug for the remainder of the study (14 weeks). The difference in mean trough serum antigenic α1-PI level between the treatment groups was 1.45 μM (90% CI-2.77, -0.13), signifying bioequivalence. The mean trough serum antigenic α1-PI level in the study drug group was greater than the therapeutic threshold of 11 μM, achieving a level of 17.7 μM during the steady-state period. Treatment-related adverse events (AEs) were seen in 7% and 21% of study and control drug treated subjects, respectively. No documented viral transmission occurred. These results demonstrate that the new plasma derived α1-PI (Zemaira) is bioequivalent to the currently available product Prolastin, is well tolerated, and safe with respect to the risk of viral transmission.

Original languageEnglish (US)
Pages (from-to)17-23
Number of pages7
JournalCOPD: Journal of Chronic Obstructive Pulmonary Disease
Volume3
Issue number1
DOIs
StatePublished - 2006

Fingerprint

alpha 1-Antitrypsin
Peptide Hydrolases
Safety
Drug and Narcotic Control
Serum
Prussia
Pharmaceutical Preparations
Therapeutic Equivalency
Therapeutics
Control Groups

Keywords

  • α-antitrypsin deficiency
  • Efficacy
  • Proteinase inhibitor
  • Safety

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Multi-center study : The biochemical efficacy, safety and tolerability of a new α1-proteinase inhibitor, Zemaira. / Stocks, James M.; Brantly, Mark; Pollock, David; Barker, Alan; Kueppers, Friedrich; Strange, Charlie; Donohue, James F.; Sandhaus, Robert.

In: COPD: Journal of Chronic Obstructive Pulmonary Disease, Vol. 3, No. 1, 2006, p. 17-23.

Research output: Contribution to journalArticle

Stocks, James M. ; Brantly, Mark ; Pollock, David ; Barker, Alan ; Kueppers, Friedrich ; Strange, Charlie ; Donohue, James F. ; Sandhaus, Robert. / Multi-center study : The biochemical efficacy, safety and tolerability of a new α1-proteinase inhibitor, Zemaira. In: COPD: Journal of Chronic Obstructive Pulmonary Disease. 2006 ; Vol. 3, No. 1. pp. 17-23.
@article{6a8cc40f67ed4b0b9e9d71f16c75bae6,
title = "Multi-center study: The biochemical efficacy, safety and tolerability of a new α1-proteinase inhibitor, Zemaira",
abstract = "Augmentation therapy with a plasma derived α1-Proteinase Inhibitor (α1-PI) has been demonstrated to be effective in restoring serum Alpha1-antitrypsin (AAT)* levels in individuals with AAT Deficiency (note: α1 PI and AAT are synonymous). The objective of this study was to demonstrate that the steady-state trough serum α1-PI levels, achieved by a new plasma derived α1-PI (Zemaira, study drug, ZLB Behring LLC, King of Prussia, Pennsylvania, USA), were bioequivalent to those achieved by the currently available α1-PI therapy, Prolastin (control drug, Bayer Corporation, Berkeley, California, USA), and maintained weekly trough serum antigenic α1-PI levels above the protective threshold of 11 μM. This multi-center, controlled study randomized a total of 44 subjects to receive either study or control drug for a 10-week double-blind phase. The control group was then crossed over to receive the study drug for the remainder of the study (14 weeks). The difference in mean trough serum antigenic α1-PI level between the treatment groups was 1.45 μM (90{\%} CI-2.77, -0.13), signifying bioequivalence. The mean trough serum antigenic α1-PI level in the study drug group was greater than the therapeutic threshold of 11 μM, achieving a level of 17.7 μM during the steady-state period. Treatment-related adverse events (AEs) were seen in 7{\%} and 21{\%} of study and control drug treated subjects, respectively. No documented viral transmission occurred. These results demonstrate that the new plasma derived α1-PI (Zemaira) is bioequivalent to the currently available product Prolastin, is well tolerated, and safe with respect to the risk of viral transmission.",
keywords = "α-antitrypsin deficiency, Efficacy, Proteinase inhibitor, Safety",
author = "Stocks, {James M.} and Mark Brantly and David Pollock and Alan Barker and Friedrich Kueppers and Charlie Strange and Donohue, {James F.} and Robert Sandhaus",
year = "2006",
doi = "10.1080/15412550500493220",
language = "English (US)",
volume = "3",
pages = "17--23",
journal = "COPD: Journal of Chronic Obstructive Pulmonary Disease",
issn = "1541-2555",
publisher = "Informa Healthcare",
number = "1",

}

TY - JOUR

T1 - Multi-center study

T2 - The biochemical efficacy, safety and tolerability of a new α1-proteinase inhibitor, Zemaira

AU - Stocks, James M.

AU - Brantly, Mark

AU - Pollock, David

AU - Barker, Alan

AU - Kueppers, Friedrich

AU - Strange, Charlie

AU - Donohue, James F.

AU - Sandhaus, Robert

PY - 2006

Y1 - 2006

N2 - Augmentation therapy with a plasma derived α1-Proteinase Inhibitor (α1-PI) has been demonstrated to be effective in restoring serum Alpha1-antitrypsin (AAT)* levels in individuals with AAT Deficiency (note: α1 PI and AAT are synonymous). The objective of this study was to demonstrate that the steady-state trough serum α1-PI levels, achieved by a new plasma derived α1-PI (Zemaira, study drug, ZLB Behring LLC, King of Prussia, Pennsylvania, USA), were bioequivalent to those achieved by the currently available α1-PI therapy, Prolastin (control drug, Bayer Corporation, Berkeley, California, USA), and maintained weekly trough serum antigenic α1-PI levels above the protective threshold of 11 μM. This multi-center, controlled study randomized a total of 44 subjects to receive either study or control drug for a 10-week double-blind phase. The control group was then crossed over to receive the study drug for the remainder of the study (14 weeks). The difference in mean trough serum antigenic α1-PI level between the treatment groups was 1.45 μM (90% CI-2.77, -0.13), signifying bioequivalence. The mean trough serum antigenic α1-PI level in the study drug group was greater than the therapeutic threshold of 11 μM, achieving a level of 17.7 μM during the steady-state period. Treatment-related adverse events (AEs) were seen in 7% and 21% of study and control drug treated subjects, respectively. No documented viral transmission occurred. These results demonstrate that the new plasma derived α1-PI (Zemaira) is bioequivalent to the currently available product Prolastin, is well tolerated, and safe with respect to the risk of viral transmission.

AB - Augmentation therapy with a plasma derived α1-Proteinase Inhibitor (α1-PI) has been demonstrated to be effective in restoring serum Alpha1-antitrypsin (AAT)* levels in individuals with AAT Deficiency (note: α1 PI and AAT are synonymous). The objective of this study was to demonstrate that the steady-state trough serum α1-PI levels, achieved by a new plasma derived α1-PI (Zemaira, study drug, ZLB Behring LLC, King of Prussia, Pennsylvania, USA), were bioequivalent to those achieved by the currently available α1-PI therapy, Prolastin (control drug, Bayer Corporation, Berkeley, California, USA), and maintained weekly trough serum antigenic α1-PI levels above the protective threshold of 11 μM. This multi-center, controlled study randomized a total of 44 subjects to receive either study or control drug for a 10-week double-blind phase. The control group was then crossed over to receive the study drug for the remainder of the study (14 weeks). The difference in mean trough serum antigenic α1-PI level between the treatment groups was 1.45 μM (90% CI-2.77, -0.13), signifying bioequivalence. The mean trough serum antigenic α1-PI level in the study drug group was greater than the therapeutic threshold of 11 μM, achieving a level of 17.7 μM during the steady-state period. Treatment-related adverse events (AEs) were seen in 7% and 21% of study and control drug treated subjects, respectively. No documented viral transmission occurred. These results demonstrate that the new plasma derived α1-PI (Zemaira) is bioequivalent to the currently available product Prolastin, is well tolerated, and safe with respect to the risk of viral transmission.

KW - α-antitrypsin deficiency

KW - Efficacy

KW - Proteinase inhibitor

KW - Safety

UR - http://www.scopus.com/inward/record.url?scp=33745032125&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33745032125&partnerID=8YFLogxK

U2 - 10.1080/15412550500493220

DO - 10.1080/15412550500493220

M3 - Article

C2 - 17175661

AN - SCOPUS:33745032125

VL - 3

SP - 17

EP - 23

JO - COPD: Journal of Chronic Obstructive Pulmonary Disease

JF - COPD: Journal of Chronic Obstructive Pulmonary Disease

SN - 1541-2555

IS - 1

ER -