Methods of treating patients with immune-related diseases

A method of treating a patient suspected of having an immune-related disease, the method comprising (a) identifying a biomarker of said immune-related disease in said patient;

• (b) identifying a marker of pathogenic immunological activity in said patient;
• and (c) treating said patient with a therapeutically effective course of treatment if said biomarker of said immune-related disease and said marker of pathogenic immunological activity are identified in said patient, said course of treatment comprising a dosing regimen with an anti-CD3 antibody or antigen-binding fragment thereof, wherein said antibody or fragment does not bind or has reduced binding to at least one Fc (gamma) receptor compared to the IgG1 immunoglobulin molecule produced by the cell line ARH-77 deposited under ATCC catalog number CRL-1621.

(canceled)

A method of treating a patient suspected of having diabetes, the method comprising (a) identifying a biomarker of diabetes in said patient;

• (b) identifying a marker of pathogenic immunological activity in said patient;
• and (c) treating said patient with a therapeutically effective course of treatment if said biomarker of said immune-related disease and said marker of pathogenic immunological activity are identified in said patient, said course of treatment comprising a dosing regimen with an anti-CD3 antibody or antigen-binding fragment thereof, wherein said antibody or fragment does not bind or has reduced binding to at least one Fc (gamma) receptor compared to the IgG1 immunoglobulin molecule produced by the cell line ARH-77 deposited under ATCC catalog number CRL-1621.

(canceled)

A method of re-treating a patient with an immune-related disease, wherein said patient has undergone at least one course of treatment with a dosing regimen with an anti-CD3 antibody or antigen-binding fragment thereof after identification in said patient of a marker of said immune-related disease and a marker of pathogenic immunological activity, and wherein said antibody or fragment does not bind or has reduced binding to at least one Fc (gamma) receptor compared to the IgG1 immunoglobulin molecule produced by the cell line ARH-77 deposited under ATCC catalog number CRL-1621, said method comprising:

• a) monitoring said patient for an indicator of return to active disease;
• and
• b) re-dosing said patient with an additional course of treatment with a dosing regimen of said anti-CD3 antibody or antigen-binding fragment thereof if said indicator is identified in said patient.

(canceled)

(canceled)

-66. (canceled)