Multiple-variable il-2 dose regimen for treating immune disorders

Abstract

The present invention is based, in part, on the identification of methods of using multiple-variable IL-2 doses for identifying, assessing, preventing, and treating immune disorders.

1 - 36 . (canceled) 
     
     
         37 . A method of stratifying subjects afflicted with an immune disorder according to benefit from a fixed daily IL-2 dose treatment method comprising obtaining a biological sample comprising T lymphocytes from a subject and determining the ratio of regulatory T lymphocytes (Tregs) to conventional T lymphocytes (Tcons) (Tregs:Tcons) in the subject sample, wherein the Tregs:Tcons ratio of greater than or equal to about 0.07 indicates that the subject would benefit from the fixed daily IL-2 dose treatment method and wherein the Tregs:Tcons ratio of less than about 0.07 indicates that the subject would not benefit from the fixed daily IL-2 dose treatment method. 
     
     
         38 . A method of stratifying subjects afflicted with an immune disorder according to benefit from a fixed daily IL-2 dose treatment method comprising obtaining a biological sample comprising T lymphocytes from a subject after the induction regiment and determining the ratio of regulatory T lymphocytes (Tregs) to conventional T lymphocytes (Tcons) (Tregs:Tcons) in the subject sample, wherein the Tregs:Tcons ratio of greater than or equal to about 0.20 indicates that the subject would benefit from the fixed daily IL-2 dose treatment method and wherein the Tregs:Tcons ratio of less than about 0.20 indicates that the subject would not benefit from the fixed daily IL-2 dose treatment method. 
     
     
         39 . The method of  claim 37 , further comprising recommending, prescribing, or administering a fixed daily IL-2 dose treatment method if the immune disorder is determined to benefit from the fixed daily IL-2 dose treatment method. 
     
     
         40 . The method of  claim 37 , further comprising recommending, prescribing, or administering anti-immune disorder therapy other than a fixed daily IL-2 dose treatment method if the immune disorder is determined to not benefit from a fixed daily IL-2 dose treatment method. 
     
     
         41 . The method of  claim 38 , further comprising recommending, prescribing, or administering a fixed daily IL-2 dose treatment method if the immune disorder is determined to benefit from the fixed daily IL-2 dose treatment method. 
     
     
         42 . The method of  claim 38 , further comprising recommending, prescribing, or administering anti-immune disorder therapy other than a fixed daily IL-2 dose treatment method if the immune disorder is determined to not benefit from a fixed daily IL-2 dose treatment method.