DELAYED-RELEASE GLUCOCORTICOID TREATMENT OF RHEUMATOID ARTHRITIS BY IMPROVING SIGNS AND SYMPTOMS, SHOWING MAJOR OR COMPLETE CLINICAL RESPONSE AND BY PREVENTING FROM JOINT DAMAGE
The present invention refers to the treatment of a patient suffering from rheumatoid arthritis by showing a reduction in signs and symptoms, a major or complete clinical response (remission) or even prevention of structural damages to the joints by administering a delayed-release dosage form of a glucocorticoid to a subject in need thereof.
1 - 47 . (canceled)
48 . A method of administering prednisone to a patient having rheumatoid arthritis with a pain level of >50-70 mm on a 100 mm self reported visual analogue scale for pain comprising
administering an oral dosage form comprising an initial dosage of 1, 2, 5, or 10 mg of prednisone, to the patient once daily at or before bedtime, wherein the oral dosage form is administered with food,
determining the patient's clinical response to said administration, and
if said patient has a satisfactory clinical response, the method further comprises administering a maintenance dosage that is less than the initial dosage until a dosage of prednisone which will maintain a satisfactory clinical response is reached, or
if said patient does not have a satisfactory clinical response, the method further comprises administering an increased dosage that is more than the initial dosage until a satisfactory clinical response is determined,
wherein release of the prednisone from the oral dosage form is delayed for a time period (tlag) of 2-10 hours after administration of the oral dosage form.
49 . The method of claim 48 , wherein the patient also is being administered a disease modifying anti-rheumatic drug.
50 . The method of claim 48 , wherein the dosage form comprises 10 mg prednisone.
51 . The method of claim 48 , wherein the dosage form comprises 5 mg prednisone.
52 . The method of claim 48 , wherein the dosage form comprises 2 mg prednisone.
53 . The method of claim 48 , wherein the dosage form comprises 1 mg prednisone.
54 . The method of claim 48 , wherein the delayed-release dosage form has a tlag of from about 2 hours to about 6 hours after administration.
55 . The method of claim 48 , wherein the delayed-release dosage form has a tlag of from about 3 hours to about 5 hours after administration.
56 . The method of claim 48 , wherein the food is a high-fat meal.