Meena Subramanyam;Julie Elizabeth Taylor;Robin Mcdaid Barbour;Lakshmi Amaravadi;Eric Wakshull;Frances Lynn;Michael Panzara
发明人:
Meena Subramanyam,Lakshmi Amaravadi,Eric Wakshull,Frances Lynn,Michael Panzara,Robin Mcdaid Barbour,Julie Elizabeth Taylor
申请号：
US13242505
公开号：
US20120195884A1
申请日:
2011.09.23
申请国别(地区):
US
年份:
2012
代理人:
摘要：
The invention relates to methods and products for the identification of a clinically significant immune response in subjects treated with a therapeutic protein. Aspects of the invention relate to methods and compositions for identifying a clinically significant immune response in patients treated with therapeutic amounts of a VLA4 binding antibody (e.g., natalizumab). A second aspect of the invention concerns the chronological details of sample collection for determining the titre of antibodies against the therapeutic protein, e.g. the collection of at least two samples at two different time points. A third aspect of the invention relates to the selection of the critical threshold level, which corresponds to the antibody titre of untreated patients increased by the double of the standard deviation of this control antibody titre.
