Rabeximod in the treatment of rheumatoid arthritis

Abstract

The present invention relates to therapeutic uses of compositions comprising 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo-[2,3-b]quinoxaline in the treatment of human subjects suffering from Rheumatoid Arthritis.

1 . A method of treating a human subject suffering from and/or diagnosed with rheumatoid arthritis, said method comprising the oral administration to said subject, of a composition comprising 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo-[2,3-b]quinoxaline (rabeximod) or a pharmaceutically acceptable salt thereof, wherein the method comprises the oral administration of rabeximod at a daily dosage within the range of 1-50 mg, or the oral administration of a salt of rabeximod at the equivalent daily dosage. 
     
     
         2 . The method according to  claim 1 , wherein the method comprises the oral administration of rabeximod at a daily dosage within the range of 1-40 mg, or the oral administration of a salt of rabeximod at the equivalent daily dosage. 
     
     
         3 . The method according to  claim 1 , wherein the method comprises the oral administration of rabeximod at a daily dosage within the range of 5-25 mg, or the oral administration of a salt of rabeximod at the equivalent daily dosage. 
     
     
         4 . The method according to  claim 1 , wherein the method comprises the administration of rabeximod or a salt thereof in a dosage regime resulting in a rabeximod plasma level, at steady-state, that is within the range of 25-150 ng/ml throughout the dosing interval. 
     
     
         5 . The method according to  claim 1 , wherein the composition comprising rabeximod is a solid unit dosage form suitable for oral administration, preferably a filled capsule, comprising rabeximod in micronized form. 
     
     
         6 . The method according to  claim 1 , wherein the method is a method of treating rheumatoid arthritis, delaying the progression of rheumatoid arthritis, stopping or preventing the progression of rheumatoid arthritis, inducing remission of rheumatoid arthritis, delaying the onset of rheumatoid arthritis or preventing the onset of rheumatoid arthritis. 
     
     
         7 . The method according to  claim 1 , wherein the method is a method of treating a symptom of rheumatoid arthritis, delaying the progression of a symptom of rheumatoid arthritis, stopping or preventing the progression of a symptom of rheumatoid arthritis, inducing remission of a symptom of rheumatoid arthritis, de-laying the onset of a symptom of rheumatoid arthritis or preventing the onset of a symptom rheumatoid arthritis, and wherein the symptom is selected from the group consisting of tender, warm and/or swollen joints; joint stiffness, particularly in the morning and after periods of inactivity. 
     
     
         8 . The method according to  claim 1 , wherein the subject is a poor responder to treatment with methotrexate. 
     
     
         9 . The method according to  claim 1 , wherein the subject to be treated is a human subject suffering from rheumatoid arthritis of global functional status class of II, III or IV, preferably III or IV. 
     
     
         10 . The method according to  claim 1 , wherein the method achieves one or more of an ACR20 response, a reduction in the duration of morning stiffness and a reduction in mean swollen and tender and swollen joint count 66/68. 
     
     
         11 . The method according to  claim 10 , wherein the method achieves one or more of an ACR20 response, a reduction in the duration of morning stiffness and a reduction in mean swollen and tender and swollen joint count 66/68, within a period of 14-18 weeks. 
     
     
         12 . The method according to  claim 1 , wherein the method comprises the repeated administration of the composition containing rabeximod or a salt thereof, during a period of at least 12 weeks, preferably at least 16 weeks. 
     
     
         13 . The method according to  claim 1 , wherein, the method further comprises treatment of the subject with methotrexate.