Estriol therapy for multiple sclerosis and other autoimmune diseases

Abstract

The present invention discloses administering steroid hormones to mammals to treat autoimmune related diseases, more particularly, Th1-mediated (cell-mediated) autoimmune diseases including: multiple sclerosis (MS), rheumatoid arthritis (RA), autoimmune thyroiditis and uveitis. Most preferably the invention is used to treat a patient with a therapeutically effective amount of estriol of 8 milligrams once daily via oral administration to treat the symptoms or prevent the onset of multiple sclerosis.

1 - 39 . (canceled) 
     
     
         40 . A method for treating an autoimmune disease in a human patient, comprising administering to the patient about 4 mg to about 16 mg of estriol daily. 
     
     
         41 . The method of  claim 40 , comprising administering to the patient about 8 mg of estriol daily. 
     
     
         42 . The method of  claim 40 , wherein the estriol is estriol succinate, estriol sulfamate, or estriol dihexanoate. 
     
     
         43 . The method of  claim 40 , wherein the treatment results in a serum estriol concentration of at least about 2 ng/mL. 
     
     
         44 . The method of  claim 43 , wherein the treatment results in a serum estriol concentration of about 10 ng/mL to about 35 ng/mL. 
     
     
         45 . The method of  claim 40 , further comprising administering to the patient a progesterone. 
     
     
         46 . The method of  claim 40 , further comprising administering to the patient β-interferon, glatiramer acetate copolymer-1, mitoxantrone, natalizumab, mycophenolate mofetil, paclitaxel, cyclosporine, prednisone, methylprednisone, azathioprine, cyclophosphamide, methotrexate, cladribine, 4-aminopyridine, or tizanidine. 
     
     
         47 . The method of  claim 46 , comprising administering to the patient glatiramer acetate copolymer-1, wherein the glatiramer acetate copolymer-1 is administered at about 0 mg to about 20 mg per day. 
     
     
         48 . The method of  claim 47 , wherein the glatiramer acetate copolymer-1 is administered at about 20 mg per day. 
     
     
         49 . The method of  claim 46 , comprising administering to the patient β-interferon, wherein the β-interferon is interferon β-1a or interferon β-1b. 
     
     
         50 . The method of  claim 49 , comprising administering to the patient interferon β-1a, wherein the interferon β-1a is administered at about 0 μg to about 30 μg once per week. 
     
     
         51 . The method of  claim 50 , wherein the interferon β-1a is administered at about 30 μg once per week. 
     
     
         52 . The method of  claim 49 , comprising administering to the patient interferon β-1b, wherein the interferon β-1b is administered at about 0 mg to about 0.25 mg every other day. 
     
     
         53 . The method of  claim 52 , wherein the interferon β-1b is administered at about 0.25 mg every other day. 
     
     
         54 . The method of  claim 46 , comprising administering to the patient prednisone, wherein the prednisone is administered at about 5 mg to about 60 mg per day. 
     
     
         55 . The method of  claim 46 , comprising administering to the patient methylprednisone, wherein the methylprednisone is administered at about 1 mg to about 2 mg per day. 
     
     
         56 . The method of  claim 40 , wherein the estriol is administered orally. 
     
     
         57 . The method of  claim 40 , wherein the autoimmune disease is multiple sclerosis, rheumatoid arthritis, autoimmune thyroiditis, uveitis, myasthenia gravis, Sjogren's syndrome, or Hashimoto's thyroiditis. 
     
     
         58 . The method of  claim 57 , wherein the autoimmune disease is multiple sclerosis. 
     
     
         59 . The method of  claim 58 , wherein the autoimmune disease is relapsing remitting multiple sclerosis or secondary progressive multiple sclerosis. 
     
     
         60 . A method for treating an autoimmune disease in a human patient, comprising:
 administering to the patient about 4 mg to about 16 mg of estriol daily;   administering to the patient a progesterone; and   administering to the patient β-interferon, glatiramer acetate copolymer-1, mitoxantrone, natalizumab, mycophenolate mofetil, paclitaxel, cyclosporine, prednisone, methylprednisone, azathioprine, cyclophosphamide, methotrexate, cladribine, 4-aminopyridine, or tizanidine.