Combination therapies comprising apremilast and tyk2 inhibitors

Abstract

Provided herein are methods of treating diseases and disorder responsive to the inhibition of PDE4 comprising administering apremilast and a Tyk2 inhibitor to a subject. Also provided herein are pharmaceutical compositions comprising apremilast and a Tyk2 inhibitor.

1 - 49 . (canceled) 
     
     
         50 . A pharmaceutical composition comprising a therapeutically effective amount of N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or a pharmaceutically acceptable thereof; and a therapeutically effective amount of a Tyk2 inhibitor of the formula: 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof. 
     
     
         51 . (canceled) 
     
     
         52 . The pharmaceutical composition of  claim 50 , wherein the composition is formulated for administration of from about 2 mg/day to about 14 mg/day of the Tyk inhibitor. 
     
     
         53 . The pharmaceutical composition of  claim 50 , wherein the composition is formulated for administration of about 4 mg/day, about 6 mg/day, or about 12 mg/day of the Tyk inhibitor. 
     
     
         54 . The pharmaceutical composition of  claim 50 , wherein the composition is formulated for administration of from about 10 mg to about 60 mg per day of N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or the pharmaceutically acceptable salt thereof. 
     
     
         55 . (canceled) 
     
     
         56 . (canceled) 
     
     
         57 . The pharmaceutical composition of  claim 50 , wherein the composition is formulated for administration of about 30 mg per day or about 60 mg per day of N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or the pharmaceutically acceptable salt thereof. 
     
     
         58 . The pharmaceutical composition of  claim 50 , wherein the composition is formulated for administration of about 30 mg once daily of N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or the pharmaceutically acceptable salt thereof. 
     
     
         59 . The pharmaceutical composition of  claim 50 , wherein the composition is formulated for administration of about 30 mg twice daily of N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or the pharmaceutically acceptable salt thereof. 
     
     
         60 . The pharmaceutical composition of  claim 50 , wherein the pharmaceutical composition is in the form of a tablet or a capsule. 
     
     
         61 . The pharmaceutical composition of  claim 50 , wherein the pharmaceutical composition is formulated for extended release. 
     
     
         62 . The pharmaceutical composition of  claim 50 , wherein the pharmaceutical composition is formulated for immediate release.