Treatment of SLE with dehydroepiandrosterone

Abstract

This invention provides a method of treating systemic lupus erythematosus (SLE) with (DHEA) and a related pharmaceutical product.

What is claimed is:  
     
         1 . A method for treating systemic lupus erythematosus (SLE), comprising: 
 a) administering an effective amount of a pharmaceutically active form of DHEA to an individual with SLE;    b) at least about 4 weeks after initiating DHEA administration, determining the following disease-activity and constitutional-symptom variables characterizing the individual's SLE condition: SLEDAI, KFSS, VAS, and SLAM; and    c) determining the differences between the values for SLEDAI, KFSS, VAS, and SLAM after initiating DHEA administration and baseline values for SLEDAI, KFSS, VAS, and SLAM before initiating DHEA administration, wherein a decrease in three of these four variables and either a decrease, no change, or an increase of no more that about 5% of a baseline value in the fourth variable indicates that the individual is responding to said DHEA administration.    
     
     
         2 . The method of  claim 1 , wherein the individual is a human SLE patient.  
     
     
         3 . The method of  claim 2 , wherein the SLE patient has a SLEDAI value greater than 2.  
     
     
         4 . The method of  claim 3 , wherein at least about 85% of the DHEA administered is present as the form I polymorph, the form II polymorph, or a combination thereof.  
     
     
         5 . The method of  claim 4 , wherein as least about 95% of the DHEA administered is present as the form I polymorph, the form II polymorph, or a combination thereof.  
     
     
         6 . The method of  claim 5 , wherein as least about 95% of the DHEA administered is present as the form I polymorph.  
     
     
         7 . The method of  claim 5 , wherein as least about 95% of the DHEA administered is present as the form II polymorph.  
     
     
         8 . The method of  claim 3 , wherein the DHEA is administered at a dose and for a period effective to produce a decrease in three of the four disease-activity and constitutional-symptom variables characterizing an individual's SLE condition and either a decrease, no change, or an increase of no more that about 3% of a pretreatment baseline value in the fourth variable.  
     
     
         9 . The method of  claim 3 , wherein the DHEA is administered at a dose effective to reduce the risk of an SLE flare at about 200 days of DHEA administration by at least about 5%.  
     
     
         10 . The method of  claim 3 , wherein said administering comprises administering a daily oral dose of at least about 100 mg of a pharmaceutically active DHEA to the SLE patient.  
     
     
         11 . The method of  claim 10 , wherein the dose is at least about 200 mg DHEA/day, for a period of at least about 40 weeks.  
     
     
         12 . The method of  claim 10 , wherein the SLE patient is receiving an orally administered drug selected from the group consisting of: a glucocorticoid, a non-steroidal anti-inflammatory agent, an immunosuppressant, and an anti-malarial drug prior to administration of DHEA, and said method includes continuing administration of said drug during the period of DHEA administration.  
     
     
         13 . The method of  claim 12 , wherein said drug is prednisone, at a daily dose of at least 2 mg.  
     
     
         14 . A pharmaceutical product for use in treating systemic lupus erythematosus (SLE) in an individual, comprising: 
 a) a plurality of doses of a pharmaceutically active form of DHEA, and    b) instructions directing that: 
 i) an effective amount of a pharmaceutically active form of DHEA be administered to an individual with SLE  
 ii) the following disease-activity and constitutional-symptom variables characterizing the individual's SLE condition be determined: SLEDAI, KFSS, VAS, and SLAM at least about after initiating DHEA administration; and  
 ii) the differences between the values for SLEDAI, KFSS, VAS, and SLAM after initiating DHEA administration and baseline values for SLEDAI, KFSS, VAS, and SLAM before initiating DHEA administration be determined, wherein a decrease in three of these four variables and either a decrease, no change, or an increase of no more that about 5% of a baseline value in the fourth variable indicates that the individual is responding to said DHEA administration.  
   
     
     
         15 . The pharmaceutical product of  claim 14 , wherein the individual is a human SLE patient.  
     
     
         16 . The pharmaceutical product of  claim 15 , wherein the instructions specify selecting those SLE patients having a SLEDAI value is greater than 2 for DHEA administration.  
     
     
         17 . The pharmaceutical product of  claim 16 , wherein at least about 85% of the DHEA is present as the form I polymorph, the form II polymorph, or a combination thereof.  
     
     
         18 . The pharmaceutical product of  claim 17 , wherein as least about 95% of the DHEA is present as the form I polymorph, the form II polymorph, or a combination thereof.  
     
     
         19 . The pharmaceutical product of  claim 18 , wherein as least about 95% of the DHEA is present as the form I polymorph.  
     
     
         20 . The pharmaceutical product of  claim 18 , wherein as least about 95% of the DHEA is present as the form II polymorph.  
     
     
         21 . The pharmaceutical product of  claim 14 , wherein the doses of DHEA are capsules or tablets comprising 50 mgs. DHEA per capsule or tablet, respectively.  
     
     
         22 . The pharmaceutical product of  claim 14 , wherein the instructions specify administering DHEA orally at a dose of at least about 100 mg DHEA per day.  
     
     
         23 . The pharmaceutical product of  claim 24 , wherein the instructions specify administering DHEA orally at a dose of at least about 200 mg DHEA per day.  
     
     
         24 . Use of the pharmaceutical product of  claim 14 , for treating systemic lupus erythematosus (SLE) in a human patient.