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.

1 - 79 . (canceled) 
     
     
         80 . A method for treatment of a patient suffering from signs and symptoms of polymyalgia rheumatica comprising administering to said patient an effective amount of a glucocorticoid contained in a delayed-release dosage form, wherein said treatment is administered once daily for at least about two weeks. 
     
     
         81 . The method of  claim 80 , wherein the treatment comprises administration of the glucocorticoid for at least about four weeks. 
     
     
         82 . The method of  claim 81 , wherein the treatment comprises administration of the glucocorticoid for at least about eight weeks. 
     
     
         83 . The method of  claim 82 , wherein the treatment comprises administration of the glucocorticoid for at least about twelve weeks. 
     
     
         84 . The method of  claim 83 , wherein the treatment comprises administration of the glucocorticoid for at least about twelve months. 
     
     
         85 . The method of  claim 80 , wherein the glucocorticoid dose is greater than about 10 mg/day of prednisone, or an equivalent amount of another glucocorticoid, at the initiation of the therapy. 
     
     
         86 . The method of  claim 80 , wherein the glucocorticoid dose is equal to or less than about 10 mg/day of prednisone, or an equivalent amount of another glucocorticoid, for maintenance therapy. 
     
     
         87 . The method of  claim 80 , wherein said patient has not previously been treated with one or more of an oral immediate release glucocorticoid, an NSAID, a DMARD, a TNFα inhibitor, an IL-1 inhibitor, an IL-6 inhibitor, and an analgetic agent. 
     
     
         88 . The method of  claim 80 , wherein said patient has previously undergone treatment with one or more of an oral immediate release dosage form of a glucocorticoid, an NSAID, a DMARD, a TNFα inhibitor, an IL-1 inhibitor, an IL-6 inhibitor, and an analgetic agent. 
     
     
         89 . The method of  claim 88 , wherein said patient is refractory to said treatment with an oral immediate release dosage form of a glucocorticoid. 
     
     
         90 . The method of  claim 80 , which further comprises administering to said patient an effective amount of one or more of an NSAID, a DMARD, a TNFα inhibitor, an IL-1 inhibitor, an IL-6 inhibitor, and an analgetic agent. 
     
     
         91 . 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. 
     
     
         92 . 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. 
     
     
         93 . 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. 
     
     
         94 . The method of  claim 80 , wherein the delayed-release dosage form has a drug release behavior which is independent of pH. 
     
     
         95 . The method of  claim 80 , wherein the delayed release dosage form is a tablet or a capsule. 
     
     
         96 . The method of  claim 80 , wherein the delayed-release dosage form comprises a non-soluble/non-swellable coating and a core comprising the active agent and a disintegrant and/or a swelling agent. 
     
     
         97 . The method of  claim 80 , wherein the glucocorticoid is cortisone, hydrocortisone, prednisone, prednisolone, methylprednisolone, budesonide, dexamethasone, fludrocortisone, fluocortolone, cloprednole, deflazacort, or triamcinolone, or a pharmaceutically acceptable salt thereof. 
     
     
         98 . The method of  claim 97 , wherein the glucocorticoid is prednisone, prednisolone, methylprednisolone, dexamethasone, fluocortolone, cloprednole, or deflazacort, or a pharmaceutically acceptable salt thereof. 
     
     
         99 . The method of  claim 80 , wherein said delayed-release dosage form is effective at a lower dose of glucocorticoid as compared to the administration of said glucocorticoid in an immediate release dosage form. 
     
     
         100 . The method of  claim 80 , wherein said patient suffers from inflammation. 
     
     
         101 . The method of  claim 80 , wherein the glucocorticoid is administered in the evening. 
     
     
         102 . The method of  claim 101 , wherein the glucocorticoid is administered between about 9:00 pm and about 11:00 pm. 
     
     
         103 . The method of  claim 80 , wherein the signs and symptoms of polymyalgia rheumatica comprise morning stiffness and pain.