Methods and products for evaluating an immune response to a therapeutic protein
AssigneeBiogen MA Inc.
InventorsMeena Subramanyam, Lakshimi Amaravadi, Eric Wakshull, Frances Lynn, Michael Panzara, Robin McDaid Barbour, Julie Elizabeth Taylor
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Abstract
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).
Claims11
A method of adjusting a natalizumab therapeutic regimen in a patient who has been administered natalizumab, the method comprising detecting a level of serum antibody to natalizumab from two or more biological samples taken at different time points from the patient, and discontinuing the natalizumab therapeutic regimen when the level of serum antibody to natalizumab is above a predetermined clinically relevant threshold, wherein said clinically relevant threshold is equal to about 500 ng/mL.
Dependencies are inferred from the claim text.