Autoimmune therapy

Abstract

The present invention relates to naltrexone or an analogue thereof, wherein the analogue is methylnaltrexone, naloxone, nalmefene and nalorphine and vitamin D or an active metabolite, or a pharmaceutically acceptable salt of either for separate, sequential or simultaneous administration, for use in the therapy of an autoimmune disease.

1 . A method of treating an autoimmune disease comprising administering separately, sequentially or simultaneously (i) a naltrexone product and (ii) a vitamin D product,
 wherein the naltrexone product is selected from naltrexone, methylnaltrexone, naloxone, nalmefene, nalorphine, 6-p-naltrexol or pharmaceutically acceptable salts thereof,   wherein the vitamin D product is vitamin D or an active metabolite or a pharmaceutically acceptable salt of either.   
     
     
         2 . The method of  claim 1 , comprising administering the vitamin D product to the subject in an amount sufficient to bring the subject's blood vitamin D concentration to within a range of from 40 to 120 ng/ml. 
     
     
         3 . The method of  claim 1 , comprising administering the naltrexone and the vitamin D simultaneously. 
     
     
         4 . The method of  claim 1 , comprising providing the naltrexone product and the vitamin D product as a combined preparation. 
     
     
         5 . The method of  claim 1 , comprising administering the naltrexone to the subject after administration of the vitamin D product, such that the concentration of vitamin D or an active metabolite thereof is within a blood/plasma concentration range of from 40 to 120 ng/ml. 
     
     
         6 . The method of  claim 1 , comprising administering the naltrexone product at a dose less than 0.5 mg/kg. 
     
     
         7 . The method of  claim 1 , comprising administering the naltrexone product at a dose between 0.01 mg/kg and 0.08 mg/kg. 
     
     
         8 . The method of  claim 1 , comprising administering the naltrexone product at a dose of from 1 to 5 mg. 
     
     
         9 . The method of  claim 1 , wherein the naltrexone product is selected from the list consisting of naltrexone, naloxone, methylnaltrexone, 6-β-naltrexol or pharmaceutically acceptable salts thereof. 
     
     
         10 . The method of  claim 1 , wherein the autoimmune disease is psoriasis, Systemic Lupus Erythematosus (SLE) or thyroiditis. 
     
     
         11 . A pharmaceutical composition comprising a naltrexone product in a combined formulation with a vitamin D product,
 wherein the naltrexone product is selected from naltrexone, methylnaltrexone, naloxone, nalmefene, nalorphine, 6-β-naltrexol or pharmaceutically acceptable salts thereof, and   wherein the vitamin D product is vitamin D or an active metabolite or a pharmaceutically acceptable salt of either.   
     
     
         12 . A pharmaceutical composition according to  claim 11 , wherein the naltrexone product is present in an amount of from 0.01 to 40 mg per tablet. 
     
     
         13 . A pharmaceutical composition according to  claim 12 , wherein the naltrexone product is present in an amount of from 0.1 to 40 mg per tablet. 
     
     
         14 . A pharmaceutical composition according to  claim 13 , wherein the naltrexone product is present in an amount of from 1 to 10 mg per tablet. 
     
     
         15 . A pharmaceutical composition according to  claim 14 , wherein the naltrexone product is present in an amount of from 3 to 4.5 mg per tablet. 
     
     
         16 . A pharmaceutical composition according to  claim 11 , wherein the naltrexone product is selected from the list consisting of naltrexone, naloxone, methylnaltrexone, 6-β-naltrexol or pharmaceutically acceptable salts thereof. 
     
     
         17 . A pharmaceutical composition according to  claim 16 , wherein the naltrexone product is naltrexone or a pharmaceutically acceptable salt thereof. 
     
     
         18 . A pharmaceutical composition according to  claim 11 , wherein the autoimmune disease is psoriasis, Systemic Lupus Erythematosus (SLE) or thyroiditis.