METHOD AND PRODUCT FOR EVALUATING IMMUNE REACTION TO THERAPEUTIC PROTEIN

摘要

PROBLEM TO BE SOLVED: To provide a method and a product for evaluating immune reaction to therapeutic protein.

SOLUTION: The invention relates to a method and a product for identifying a clinically significant immune reaction in subjects treated with therapeutic protein. A first aspect of the invention relates to a method and compositions for identifying a clinically significant immune reaction in subjects treated with therapeutic amounts of VLA4 binding antibody (e.g., natalizumab). A second aspect of the invention relates to the chronological details of sample collection for determining the titer of antibody 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 titer of untreated patients increased by the double of the standard deviation of this control antibody titer.

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