Methods of treating generalized pustular psoriasis (gpp) using il-17 antagonists

Abstract

The disclosure is directed to methods, treatment regimens, uses, kits and therapies for treating Generalized Pustular Psoriasis (GPP). These methods, treatment regimens, uses, kits and therapies utilize, inter alia, administration of an IL-17 antagonist, e.g., an IL-17 antibody, such as secukinumab. Additionally disclosed are improved methods for treating plaque-type psoriasis that utilize up-titration and down-titration of the IL-17 antagonist, e.g., an IL-17 antibody, such as secukinumab, as well as modification of dose frequency. Further disclosed are methods of treating palmoplantar pustular psoriasis using the disclosed IL-17 antagonists, e.g., IL-17 antibodies, such as secukinumab.

What is claimed is: 
     
         1 . A method of treating Generalized Pustular Psoriasis (GPP), comprising administering to a patient in need thereof an IL-17 antibody or antigen binding fragment thereof, wherein the IL-17 antibody or antigen binding fragment binds to an epitope of an IL-17 homodimer having two mature human IL-17 protein chains, said epitope comprising Leu74, Tyr85, His86, Met87, Asn88, Val124, Thr125, Pro126, Ile127, Val128, His129 on one chain and Tyr43, Tyr44, Arg46, Ala79, Asp80 on the other chain, wherein the IL-17 antibody or antigen binding fragment thereof has a K D  of about 100-about 200 pM as measured by Biacore®, and wherein the IL-17 antibody or antigen binding fragment thereof has an in vivo half-life of about 23-about 30 days. 
     
     
         2 . A method of treating GPP, comprising subcutaneously administering an IL-17 antibody or antigen binding fragment thereof to a patient in need thereof as a dose of about 150 mg-about 300 mg with initial dosing at weeks 0, 1, 2 and 3, followed by monthly dosing starting at week 4. 
     
     
         3 . A method of treating GPP, comprising
 a) subcutaneously administering an IL-17 antibody or antigen binding fragment thereof to a patient in need thereof at a dose of about 150 mg during weeks 0, 1, 2, 3, and 4; and   b) thereafter, subcutaneously administering the IL-17 antibody or antigen binding fragment thereof to the patient at a dose of about 300 mg during week 8, 9, and 12 and then monthly thereafter, beginning during week 16.   
     
     
         4 . A method of treating GPP, comprising
 a) subcutaneously administering an IL-17 antibody or antigen binding fragment thereof to a patient in need thereof at a dose of about 150 mg during weeks 0, 1, 2, 3, and 4;   b) assigning the patient to a treatment assessment based on clinical components of a CGI evaluation administered during week 8, wherein assigning a treatment assessment “very much improved” or “much improved” provides an indication that no up-titration is required, and wherein assigning a treatment assessment “worse”, “no change” or “minimally improved” provides an indication that up-titration is required; and   c)   i) thereafter, subcutaneously administering the IL-17 antibody or antigen binding fragment thereof to the patient at a dose of about 150 mg monthly, beginning during week 8, if no up-titration is required; or   ii) thereafter, subcutaneously administering the IL-17 antibody or antigen binding fragment thereof to the patient at a dose of about 300 mg during weeks 8, 9 and 12 and then monthly thereafter, beginning during week 16, if up-titration is required.   
     
     
         5 . A kit for the treatment of a patient having GPP, comprising,
 a) a pharmaceutical composition comprising a therapeutically effective amount of an IL-17 antibody or antigen binding fragment thereof;   b) means for administering the IL-17 antibody or antigen binding fragment thereof to the patient; and   c) instructions providing subcutaneously administering an IL-17 antibody or antigen binding fragment thereof to a patient in need thereof as a dose of about 150 mg-about 300 mg with initial dosing at weeks 0, 1, 2 and 3, followed by monthly dosing starting at week 4.   
     
     
         6 . A kit for the treatment of a patient having GPP, comprising,
 a) a pharmaceutical composition comprising a therapeutically effective amount of an IL-17 antibody or antigen binding fragment thereof;   b) means for administering the IL-17 antibody or antigen binding fragment thereof to the patient; and   c) instructions providing:   i) subcutaneously administering the IL-17 antibody or antigen binding fragment thereof to the patient at a dose of about 150 mg during weeks 0, 1, 2, 3, and 4;   ii)   I) thereafter, subcutaneously administering the IL-17 antibody or antigen binding fragment thereof to the patient at a dose of about 150 mg monthly, beginning during week 8; or   II) thereafter, subcutaneously administering the IL-17 antibody or antigen binding fragment thereof to the patient at a dose of about 300 mg during weeks 8, 9 and 12 and then monthly thereafter, beginning during week 16.   
     
     
         7 . A kit for the treatment of a patient having GPP, comprising,
 a) a pharmaceutical composition comprising a therapeutically effective amount of an IL-17 antibody or antigen binding fragment thereof;   b) means for administering the IL-17 antibody or antigen binding fragment thereof to the patient; and   c) instructions providing:   i) subcutaneously administering the IL-17 antibody or antigen binding fragment thereof to the patient at a dose of about 150 mg during weeks 0, 1, 2, 3, and 4;   ii) assigning the patient to a treatment assessment based on clinical components of a CGI evaluation administered during week 8, wherein assigning a treatment assessment “very much improved” or “much improved” provides an indication that no up-titration is required, and wherein assigning a treatment assessment “worse”, “no change” or “minimally improved” provides an indication that up-titration is required; and   iii)   I) thereafter, subcutaneously administering the IL-17 antibody or antigen binding fragment thereof to the patient at a dose of about 150 mg monthly, beginning during week 8, if no up-titration is required; or   II) thereafter, subcutaneously administering the IL-17 antibody or antigen binding fragment thereof to the patient at a dose of about 300 mg during weeks 8, 9 and 12 and then monthly thereafter, beginning during week 16, if up-titration is required.   
     
     
         8 .- 29 . (canceled)