Treatment for rheumatoid arthritis

Abstract

The present invention provides anti-GM-CSF antibodies for use in the treatment of rheumatoid arthritis. Anti-GM-CSF antibodies, in particular MOR103, are administered to patients suffering from rheumatoid arthritis at dosages that are beneficial in a clinical setting.

1 - 20 . (canceled) 
     
     
         21 . A method of treating a patient suffering from rheumatoid arthritis, said method comprising administering to said patient an anti-GM-CSF antibody subcutaneously at a dose selected from the group consisting of:
 (i) a dose of at least 1.0 mg/kg; and   (ii) a fixed dose of between 40 mg and 400 mg.   
     
     
         22 . The method of  claim 21 , wherein said antibody is administered at a dose of at least 2.0 mg/kg. 
     
     
         23 . The method of  claim 21 , wherein said antibody is administered at a fixed dose of 75 mg. 
     
     
         24 . The method of  claim 21 , wherein said antibody is administered in a manner selected from the group consisting of:
 (i) biweekly;   (ii) monthly; and   (iii) bimonthly.   
     
     
         25 . The method of  claim 21 , wherein said antibody is administered in a manner selected from the group consisting of:
 (i) every week;   (ii) every second week;   (iii) every third week;   (iv) every fourth week; and   (v) every sixth week.   
     
     
         26 . The method of  claim 25 , wherein said antibody is administered weekly. 
     
     
         27 . The method of  claim 21 , wherein said anti-GM-CSF antibody is administered in combination with a Disease-modifying antirheumatic drug (DMARD). 
     
     
         28 . The method of  claim 27 , where in the DMARD is methotrexate. 
     
     
         29 . A method of treating a patient suffering from rheumatoid arthritis, said method comprising administering to said patient an anti-GM-CSF antibody subcutaneously at a dose selected from the group consisting of:
 (i) a dose of at least 1.0 mg/kg; and   (ii) a fixed dose of between 40 mg and 400 mg;   wherein said anti-GM-CSF antibody is an antibody comprising an HCDR1 region of sequence GFTFSSYWMN (SEQ ID NO.: 2), an HCDR2 region of sequence GIENKYAGGATYYAASVKG (SEQ ID NO.: 3), an HCDR3 region of sequence GFGTDF (SEQ ID NO.: 4), an LCDR1 region of sequence SGDSIGKKYAY (SEQ ID NO.: 5), an LCDR2 region of sequence KKRPS (SEQ ID NO.: 6), and an LCDR3 region of sequence SAWGDKGM (SEQ ID NO.: 7).   
     
     
         30 . The method of  claim 21 , said anti-GM-CSF antibody further comprising a pharmaceutically acceptable carrier. 
     
     
         31 . The method of  claim 30 , wherein the pharmaceutically acceptable carrier is selected from the group consisting of: buffers; antioxidants; preservatives; alkyl parabens; low molecular weight (less than about 10 residues) polypeptides; proteins; hydrophilic polymers; amino acids; sugars including monosaccharides, disaccharides, and other carbohydrates; chelating agents; sugars; salt-forming counter-ions; metal complexes; and non-ionic surfactants. 
     
     
         32 . The method of  claim 31 , wherein the buffer is selected from the group consisting of: phosphate, citrate, histidine, and other organic acids. 
     
     
         33 . The method of  claim 31 , wherein the sugar is selected from the group consisting of: sucrose, mannitol, trehalose and sorbitol. 
     
     
         34 . The method of  claim 31 , wherein the non-ionic surfactant is selected from the group consisting of: TWEEN™ (such as Tween-80), PLURONICS™, and polyethylene glycol (PEG). 
     
     
         35 . The method of  claim 31 , wherein the buffer is histidine; the sugar is sorbitol; and the non-ionic surfactant is Tween-80. 
     
     
         36 . The method of  claim 31 , wherein the pharmaceutically acceptable carrier comprises 30 mM histidine, pH 6.0, 200 mM sorbitol, and 0.02% Tween-80. 
     
     
         37 . A method of treating a patient suffering from rheumatoid arthritis, said method comprising administering to said patient a pharmaceutical composition comprising an anti-GM-CSF antibody; a buffer which is histidine; a sugar which is sorbitol; and an non-ionic surfactant which is Tween-80 subcutaneously at a dose selected from the group consisting of:
 (iii) a dose of at least 1.0 mg/kg; and   (iv) a fixed dose of between 40 mg and 400 mg.   
     
     
         38 . A pharmaceutical composition comprising:
 (i) an anti-GM-CSF antibody;   (ii) a buffer selected from the group consisting of: phosphate, citrate, histidine and other organic acids;   (iii) a sugar selected from the group consisting of: sucrose, mannitol, trehalose and sorbitol; and   (iv) a non-ionic surfactant selected from the group consisting of: TWEEN™ (such as Tween-80), PLURONICS™, and polyethylene glycol (PEG).   
     
     
         39 . The pharmaceutical composition according to  claim 38 , wherein the buffer is histidine; the sugar is sorbitol; and the non-ionic surfactant is Tween-80. 
     
     
         40 . A pharmaceutical composition comprising an anti-GM-CSF antibody and a pharmaceutically acceptable carrier, wherein the carrier consists of 30 mM histidine, pH 6.0, 200 mM sorbitol and 0.02% Tween-80.