Method of Identifying Risk for Thyroid Disorder

Abstract

A method for identifying a patient that is at risk for developing a thyroid disorder that occurs subsequent to treatment with a regimen that depletes lymphocytes, comprising determining whether antibodies directed against thyroid peroxidase or thyroid microsomes are present in the patient, wherein if the antibodies are present in the patient then the patient is at increased risk for developing a thyroid disorder. A particular embodiment is a method for identifying a patient with multiple sclerosis that is at risk for developing a thyroid disorder that occurs subsequent to treatment with a regimen that depletes CD52-positive cells, comprising determining whether antibodies directed against thyroid peroxidase or thyroid microsomes are present in the patient, wherein if the antibodies are present in the patient then the patient is at risk for developing the thyroid disorder.

1 . A method for identifying a patient that is at risk for developing a thyroid disorder subsequent to treatment with a regimen that depletes lymphocytes, comprising determining whether antibodies directed against thyroid peroxidase or thyroid microsomes are present in the patient, wherein if the antibodies are present in the patient then the patient is at risk for developing a thyroid disorder subsequent to treatment. 
   
   
       2 . The method of  claim 1 , wherein the patient has multiple sclerosis (MS). 
   
   
       3 . The method of  claim 1  or  2 , wherein the regimen that depletes lymphocytes comprises administration of an agent that depletes CD52-positive cells. 
   
   
       4 . The method of  claim 3 , wherein the agent that depletes CD52-positive cells is an antibody that binds specifically to CD52. 
   
   
       5 . The method of  claim 4 , wherein the antibody is alemtuzumab. 
   
   
       6 . The method of  claim 4 , wherein the antibody comprises one or more CDRs having an amino acid sequence identical to the amino acid sequence of a CDR of Campath-1H. 
   
   
       7 . The method of  claim 2 , wherein the MS is relapsing remitting multiple sclerosis. 
   
   
       8 . The method of  claim 1  or  2 , wherein whether antibodies directed against thyroid peroxidase or thyroid microsomes are present in the individual is determined prior to treatment with the regimen that depletes lymphocytes. 
   
   
       9 . The method of  claim 1  or  2 , wherein whether antibodies directed against thyroid peroxidase or thyroid microsomes are present in the individual is determined after at least one course of treatment with the regimen that depletes lymphocytes. 
   
   
       10 . The method of  claim 1  or  2 , wherein the thyroid disorder is selected from the group consisting of: hypothyroidism, hyperthyroidism, Graves' disease, autoimmune thyroiditis and a combination thereof. 
   
   
       11 . The method of  claim 1  or  2 , wherein the the regimen that depletes lymphocytes is administered in connection with a bone marrow transplant procedure. 
   
   
       12 . The method of  claim 1  or  2 , wherein the antibodies directed against thyroid peroxidase or thyroid microsomes are detected using an assay selected from the group consisting of: enzyme-linked immunosorbent assay, radioimmunoassays (RIA), hemagglutination assay, and other assays which employ a form or fragment of the thyroid peroxidase protein as a target intended to attract and bind to the antibodies. 
   
   
       13 . The method of  claim 1 , wherein the patient has an immune-mediated disease selected from the group consisting of: GVHD, rheumatoid arthritis, vasculitis, organ transplant rejection, uveitis, scleroderma, autoimmune cytopenia and rheumatoid arthritis.