Methods and compositions for treating lupus

Abstract

The invention provides methods of treating lupus in a patient with an anti-CD52 antibody. Also includes are methods of increasing infiltration of regulatory T cells to affected sides of the patient's body, methods of reducing urine protein and/or albumin levels and methods of depleting lymphocytes to alleviate lupus symptoms.

1 . A method of increasing FoxP3 +  regulatory T cells in a patient with lupus, comprising administering to the patient a therapeutically effective amount of an anti-CD52 antibody. 
     
     
         2 . The method of claim  0 , wherein the method further comprises administering to the patient an agent that stimulates said regulatory T cells. 
     
     
         3 . The method of claim  0 , wherein the agent is rapamycin, a TGF-β, IL-10, IL-4, IFN-α, vitamin D3, dexamethasone, or mycophenolate mofetil. 
     
     
         4 . The method of claim  0 , wherein the TGF-β is an active or latent form of any one of TGF-β1, TGF-β2, TGF-β3, TGF-β4, and TGF-β5. 
     
     
         5 . The method of claim  0 , wherein said regulatory T cells are increased at least at one site of inflammation. 
     
     
         6 . The method of claim  0 , wherein the site of inflammation is blood, central nervous system (CNS), heart, liver, joint, kidney, lung, skin, intestinal tract, or vasculature. 
     
     
         7 . The method of  claim 1 , wherein the level of urine protein, urine albumin, or both, is reduced in the patient. 
     
     
         8 - 17 . (canceled) 
     
     
         18 . A kit for treating lupus, comprising an anti-CD52 antibody, and an agent that stimulates FoxP3 +  regulatory T cells. 
     
     
         19 . The kit of  claim 18 , wherein said agent is rapamycin, a TGF-β, IL-10, IL-4, IFN-α, vitamin D3, dexamethasone, or mycophenolate mofetil. 
     
     
         20 . The kit of  claim 19 , wherein the TGF-β is an active or latent form of any one of TGF-β1, TGF-β2, TGF-β3, TGF-β4, and TGF-β5. 
     
     
         21 - 23 . (canceled) 
     
     
         24 . The method of  claim 1 , wherein the patient is a human. 
     
     
         25 . The method of  claim 1 , wherein the anti-CD52 antibody is a humanized or human anti-human CD52 antibody. 
     
     
         26 . The kit of  claim 18 , wherein the anti-CD52 antibody is a humanized or human anti-human CD52 antibody. 
     
     
         27 . A pharmaceutical composition for treating lupus, comprising an anti-CD52 antibody and an agent that stimulates FoxP3 +  regulatory T cells. 
     
     
         28 . The pharmaceutical composition of  claim 27 , wherein said agent is rapamycin, a TGF-β, IL-10, IL-4, IFN-α, vitamin D3, dexamethasone, or mycophenolate mofetil. 
     
     
         29 . The pharmaceutical composition of  claim 28 , wherein the TGF-β is an active or latent form of any one of TGF-β1, TGF-β2, TGF-β3, TGF-β4, and TGF-β5. 
     
     
         30 . The pharmaceutical composition of  claim 27 , wherein the anti-CD52 antibody is a humanized or human anti-human CD52 antibody.