Delayed-release glucocorticoid treatment of rheumatoid disease

Abstract

The present invention refers to the treatment of a rheumatic disease and/or osteoarthritis by administering a delayed-release dosage form of a glucocorticoid to a subject in need thereof.

What is claimed is: 
     
         1 .- 79 . (canceled) 
     
     
         80 . A method for the treatment of a patient suffering from signs and symptoms of an underlying rheumatic disease and/or osteoarthritis, which comprises administering to said patient an effective amount of prednisone contained in a delayed-release dosage form,
 wherein said treatment is administered once daily for at least about two weeks,   wherein said treatment with said prednisone contained in a delayed-release dosage form provides an increased reduction in the duration of morning stiffness as compared to treatment with prednisone in an immediate release dosage form, and   wherein the delayed release dosage form is a tablet or a capsule.   
     
     
         81 . The method of  claim 80 , wherein the treatment comprises administration of the prednisone contained in a delayed-release dosage form for at least about four weeks. 
     
     
         82 . The method of  claim 80 , wherein the treatment comprises administration of the prednisone contained in a delayed-release dosage form for at least about eight weeks. 
     
     
         83 . The method of  claim 80 , wherein the treatment comprises administration of the prednisone contained in a delayed-release dosage form for at least about twelve weeks. 
     
     
         84 . The method of  claim 80 , wherein the treatment comprises administration of the prednisone contained in a delayed-release dosage form for at least about twelve months. 
     
     
         85 . The method of  claim 80 , wherein the delayed-release dosage form has a lag time of from about 2 hours to about 6 hours after administration. 
     
     
         86 . The method of  claim 80 , wherein the delayed-release dosage form has a lag time of from about 3 hours to about 5 hours after administration. 
     
     
         87 . The method of  claim 80 , wherein the delayed-release dosage form has a dissolution time of equal to or less than about 2 hours after the lag time is reached. 
     
     
         88 . The method of  claim 80 , wherein the delayed-release dosage form has a drug release behavior which is independent of pH. 
     
     
         89 . A method for the treatment of a patient suffering from signs and symptoms of an underlying rheumatic disease and/or osteoarthritis, which comprises administering to said patient an effective amount of prednisone contained in a delayed-release dosage form,
 wherein said treatment is administered once daily for at least about two weeks,   wherein said patient has previously undergone treatment with a disease-modifying antirheumatic drugs (DMARD), and   wherein the delayed release dosage form is a tablet or a capsule.   
     
     
         90 . The method of  claim 89 , wherein the treatment comprises administration of the prednisone contained in a delayed-release dosage form for at least about four weeks. 
     
     
         91 . The method of  claim 90 , wherein the treatment comprises administration of the prednisone contained in a delayed-release dosage form for at least about eight weeks. 
     
     
         92 . The method of  claim 91 , wherein the treatment comprises administration of the prednisone contained in a delayed-release dosage form one for at least about twelve weeks. 
     
     
         93 . The method of  claim 92 , wherein the treatment comprises administration of the prednisone contained in a delayed-release dosage form for at least about twelve months. 
     
     
         94 . The method of  claim 89 , wherein the rheumatic disease is rheumatoid arthritis, ankylosating spondylitis and/or polymyalgia rheumatica. 
     
     
         95 . The method of  claim 89 , wherein the delayed-release dosage form has a lag time of from about 2 hours to about 6 hours after administration. 
     
     
         96 . The method of  claim 89 , wherein the delayed-release dosage form has a lag time of from about 3 hours to about 5 hours after administration. 
     
     
         97 . The method of  claim 89 , wherein the delayed-release dosage form has a dissolution time of equal to or less than about 2 hours after the lag time is reached. 
     
     
         98 . The method of  claim 89 , wherein the delayed-release dosage form has a drug release behaviour which is independent of pH.