Combination therapy of respiratory diseases using antibodies and anti-inflammatory agents

Abstract

Therapeutically effective anti-viral compositions, useful especially against respiratory diseases caused or mediated by respiratory syncytial virus (RSV) are disclosed, wherein said compositions comprise at least one anti-RSV antibody, including high affinity antibodies, and an additional anti-inflammatory agent, especially corticosteroids, as well as anti-inflammatory antibodies, especially anti-interleukin-6. Also disclosed are methods of using such compositions to treat and/or prevent respiratory diseases. Such compositions may optionally contain other non-antibody anti-viral agents.

1 . An anti-microbial composition comprising a therapeutically effective amount of at least one anti-microbial neutralizing antibody, including therapeutically active variants and fragments thereof, and at least one anti-inflammatory agent wherein said neutralizing antibody and said anti-inflammatory agent are suspended in a pharmacologically acceptable carrier.  
   
   
       2 . The anti-microbial composition of  claim 1  wherein said antibody is an anti-viral antibody.  
   
   
       3 . The composition of  claim 1  wherein said composition comprises at least 2 anti-microbial antibodies, including therapeutically active variants and fragments thereof.  
   
   
       4 . The anti-microbial composition of  claim 1  wherein said neutralizing antibody has affinity for the F epitope of respiratory syncytial virus.  
   
   
       5 . The anti-microbial composition of  claim 1  wherein said composition comprises at least 2 anti-microbial neutralizing antibodies of differing specificity, including therapeutically active variants and fragments thereof.  
   
   
       6 . The anti-microbial composition of  claim 5  wherein said anti-microbial neutralizing antibodies comprise at least one anti-viral antibody and at least one antibody with specificity for an epitope found on a non-viral microbe.  
   
   
       7 . The anti-microbial composition of  claim 5  wherein said anti-microbial neutralizing antibodies are selected from the group consisting of antiviral, antibacterial, anti-fungal, and anti-parasitic antibodies.  
   
   
       8 . The composition of  claim 1  wherein said anti-inflammatory agent is an antibody.  
   
   
       9 . The composition of  claim 8  wherein said antibody is selected from the group consisting of an anti-cytokine, anti-chemokine, anti-interleukin antibody, an anti-interferon antibody, and an anti-tumor necrosis factor antibody.  
   
   
       10 . The composition of  claim 8  wherein said antibody is anti-interleukin-6.  
   
   
       11 . The composition of  claim 1  wherein said anti-inflammatory agent is a steroid.  
   
   
       12 . The composition of  claim 11  wherein said steroid is a corticosteroid,.  
   
   
       13 . The composition of  claim 12  wherein the corticosteroid is selected from the group consisting of cortisone, hydrocortisone, prednisone, prednisolone, methylprednisolone, triamcinolone, betamethasone, beclamethasone and dexamethasone.  
   
   
       14 . The composition of  claim 1  wherein said at least one anti-inflammatory agent is a combination of triamcinolone and methylpredisolone.  
   
   
       15 . The composition of  claim 1  wherein the anti-inflammatory agent is selected from the group consisting of ibuprofen, indomethacin, acetylsalicylic acid and acetaminophen.  
   
   
       16 . A composition comprising a therapeutically effective amount of at least one anti-respiratory syncytial virus (anti-RSV) antibody, including therapeutically active variants and fragments thereof, at least one additional anti-microbial agent, and at least one anti-inflammatory agent wherein said anti-RSV antibody, said additional anti-infectious agent, and said anti-inflammatory agent are suspended in a pharmacologically acceptable carrier, diluent or excipient.  
   
   
       17 . The composition of  claim 16  wherein said additional anti-microbial agent is an anti-viral agent and said anti-inflammatory agent is a corticosteroid.  
   
   
       18 . The composition of  claim 17  wherein said anti-viral agent is ribavirin, amantadine, rimantadine, or a neuraminidase-inhibitor.  
   
   
       19 . The composition of  claim 16  wherein said additional anti-microbial agent is an anti-bacterial agent.  
   
   
       20 . The composition of  claim 16  wherein said additional anti-microbial agent is an anti-fungal agent.  
   
   
       21 . The composition of  claim 16  wherein said additional anti-microbial agent is an anti-parasitic agent.  
   
   
       22 . A method of treating a respiratory disease in a patient afflicted therewith comprising the administering to said patient a therapeutically effective amount of a composition of  claim 1 .  
   
   
       23 . The method of  claim 22  wherein said disease is selected from the group consisting of respiratory syncytial disease, bronchiolitis, or influenza.  
   
   
       24 . The method of  claim 22  wherein said antibody is Medi-493 (or palivizumab).  
   
   
       25 . A method of protecting against a respiratory disease in a patient at risk thereof comprising administering to said patient a therapeutically effective amount of a composition of  claim 1 .  
   
   
       26 . The method of  claim 25  wherein said disease is selected from the group consisting of respiratory syncytial disease, bronchiolitis, or influenza.  
   
   
       27 . The method of  claim 25  wherein said antibody is Medi-493 (or palivizumab).