METHODS OF TREATING PSORIASIS USING IL-17 ANTAGONISTS
The disclosure relates to novel regimens for treating psoriasis, which employ a therapeutically effective amount of an IL-17 antagonist, e.g., an IL-17 binding molecule, e.g., an IL-17 antibody, such as the secukinumab antibody, or an IL-17 receptor binding molecule, e.g., an IL-17 receptor antibody.
1 . A method of treating psoriasis, comprising subcutaneously administering to a patient in need thereof a dose of about 150 mg-about 300 mg of an IL-17 antibody every four weeks, wherein the IL-17 antibody comprises:
i) an immunoglobulin variable heavy (V H ) domain comprising the amino acid sequence set forth as SEQ ID NO:8 and an immunoglobulin variable heavy (V L ) domain comprising the amino acid sequence set forth as SEQ ID NO:10;
ii) an immunoglobulin V H domain comprising the hypervariable regions set forth as SEQ ID NO:1, SEQ ID NO:2, and SEQ ID NO:3 and an immunoglobulin V L domain comprising the hypervariable regions set forth as SEQ ID NO:4, SEQ ID NO:5 and SEQ ID NO:6; or
iii) an immunoglobulin V H domain comprising the hypervariable regions set forth as SEQ ID NO:11, SEQ ID NO:12 and SEQ ID NO:13 and an immunoglobulin V L domain comprising the hypervariable regions set forth as SEQ ID NO:4, SEQ ID NO:5 and SEQ ID NO:6.
2 . The method of claim 1 , wherein the dose of the IL-17 antibody is about 150 mg or about 300 mg.
3 . The method according to claim 2 , wherein, prior to treatment with the IL-17 antibody, the patient has not been previously treated with a systemic agent for psoriasis.
4 . The method according to claim 2 , wherein, prior to treatment with the IL-17 antibody, the patient has been previously treated with a systemic agent for psoriasis.
5 . The method according to claim 4 , wherein the systemic agent is selected from the group consisting of methotrexate, cyclosporine, fumaric acid esters, acitretin, alefacept, adalimumab, efalizumab, etanercept, infliximab, golimumab and ustekinumab.
6 . The method according to claim 5 , wherein the systemic agent is methotrexate.
7 . The method of claim 2 , wherein the dose of the IL-17 antibody is about 300 mg.
8 . The method of claim 2 , wherein the dose of the IL-17 antibody is about 150 mg.
9 . The method of claim 2 , wherein the patient has plaque psoriasis.
10 . The method of claim 9 , wherein the patient has moderate to severe plaque psoriasis.
11 . The method of claim 2 , wherein the patient has palm psoriasis, sole psoriasis, face psoriasis, scalp psoriasis, genital psoriasis, or nail psoriasis.
12 . The method of claim 10 , wherein the patient is an adult patient.
13 . The method of claim 2 , wherein the IL-17 antibody is comprised in a pharmaceutical formulation, wherein said pharmaceutical formulation further comprises a buffer and a stabilizer.
14 . The method of claim 13 , wherein the pharmaceutical formulation is in liquid form.
15 . The method of claim 13 , wherein the pharmaceutical formulation is a lyophilisate for reconstitution with an aqueous carrier prior to administration to the patient.
16 . The method of claim 13 , wherein the pharmaceutical formulation is contained within at least one pre-filled syringe, at least one vial, at least one injection pen, or at least one autoinjector.
17 . The method of claim 13 , wherein the dose of the IL-17 antibody is about 300 mg, wherein the pharmaceutical formulation is contained within an autoinjector, wherein said autoinjector is contained within a kit, and wherein said kit further comprises instructions for use.
18 . The method of claim 13 , wherein the dose of the IL-17 antibody is about 150 mg, wherein the pharmaceutical formulation is contained within a pre-filled syringe, an injection pen, or an autoinjector, which is contained within a kit, and wherein said kit further comprises instructions for use.
19 . The method of claim 13 , wherein the IL-17 antibody is secukinumab.
20 . The method of claim 2 , wherein the IL-17 antibody has a T max of about 7-8 days.
21 . The method of claim 2 , wherein the IL-17 antibody has an absolute bioavailablilty of about 60-about 80%.
22 . The method of claim 2 , wherein the step of administering the IL-17 antibody every four weeks provides an average steady-state trough level of the IL-17 antibody between about 5 μg/ml-about 70 μg/ml.
23 . The method of claim 22 , wherein the step of administering the IL-17 antibody every four weeks provides an average steady-state trough level of the IL-17 antibody between about 5 μg/ml-about 33 μg/ml.
24 . The method of claim 22 , wherein the step of administering the IL-17 antibody every four weeks provides an average steady-state trough level of the IL-17 antibody between about 11 μg/ml-about 70 μg/ml.
25 . The method of claim 2 , wherein the IL-17 antibody is a human monoclonal antibody.
26 . The method of claim 25 , wherein the IL-17 antibody is of the IgG 1 /kappa isotype.
27 . The method according to claim 10 , wherein, prior to treatment with the IL-17 antibody, the patient has an Investigator Global Assessment (IGA) score of ≥3.
28 . The method of claim 2 , wherein the dose of the IL-17 antibody is about 300 mg and the patient weighs more than 90 kg.
29 . The method of claim 2 , wherein the dose of the IL-17 antibody is about 300 mg and the patient weighs more than or equal to 90 kg.
30 . The method of claim 2 , wherein the dose of the IL-17 antibody is about 300 mg and the patient weighs more than 100 kg.
31 . The method of claim 28 , wherein the IL-17 antibody is secukinumab.
32 . The method of claim 29 , wherein the IL-17 antibody is secukinumab.
33 . The method of claim 30 , wherein the IL-17 antibody is secukinumab.
34 . The method of claim 2 , wherein the dose of the IL-17 antibody is about 150 mg and the patient weighs less than 90 kg.
35 . The method of claim 2 , wherein the dose of the IL-17 antibody is about 150 mg and the patient weighs less than or equal to 90 kg.
36 . The method of claim 2 , wherein the dose of the IL-17 antibody is about 150 mg and the patient weighs less than or equal to 100 kg.
37 . A method of treating psoriasis, comprising subcutaneously administering to a patient in need thereof a dose of about 150 mg or about 300 mg secukinumab every four weeks, wherein the patient is a candidate for systemic therapy or phototherapy.
38 .- 40 . (canceled)