A METHOD FOR EVALUATING THE EFFICACY OF AN ANTIBODY USEFUL FOR EVALUATING DRUG SAFETY AND EFFICACY

摘要

The present invention relates to a method for evaluating the efficacy of an antibody that binds CD20 comprising measuring the ability of a biological sample from a patient treated with the CD20 antibody to block a biological activity of the CD20 antibody. The invention further relates to a method of detecting neutralizing antibodies to a therapeutic antibody that binds CD20 comprising exposing cells that express an antigen to which the therapeutic antibody binds to complement in the presence of the therapeutic antibody and a biological sample from a patient treated therewith, wherein the patient has an autoimmune disease; and determining complement-dependent cytotoxicity (CDC) activity of the therapeutic antibody, wherein a reduction in the CDC activity indicates the presence of neutralizing antibodies in the biological sample. The invention further provides a method of immunotherapy comprising administering an antibody that binds CD20 to a patient; and measuring the ability of a biological sample from the patient to block a biological activity of the CD20 antibody.