METHODS OF TREATING PSORIATIC ARTHRITIS USING IL-17 ANTAGONISTS
The disclosure relates to novel regimens for treating an inflammatory arthritis, e.g., psoriatic arthritis, which employ a therapeutically effective amount of an Interleukin-17 (IL-17) antagonist, e.g., IL-17 binding molecule (e.g., IL-17 antibody or antigen binding fragment thereof, e.g., secukinumab) or IL-17 receptor binding molecule (e.g., IL-17 antibody or antigen binding fragment thereof).
1 . A method of treating ankylosing spondylitis (AS), comprising:
a) subcutaneously administering to a patient in need thereof five doses of about 150 mg or 300 mg of an IL-17 antibody or antigen binding fragment thereof, each of the five doses being delivered weekly; and
b) thereafter, subcutaneously administering to the patient a dose of about 150 mg or 300 mg of the IL-17 antibody every month; wherein the IL-17 antibody or antigen binding fragment thereof 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 light (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 comprising the amino acid sequences set forth as SEQ ID NO:1-3, respectively; and an immunoglobulin V L domain comprising the hypervariable regions comprising the amino acid sequences set forth as SEQ ID NO:4-6, respectively; or
iii) an immunoglobulin V H domain comprising the hypervariable regions comprising the amino acid sequences set forth as SEQ ID NO:11-13, respectively; and an immunoglobulin VL domain comprising the hypervariable regions comprising the amino acid sequences set forth as SEQ ID NO:4-6, respectively.
2 . The method according to claim 1 , wherein the IL-17 antibody or antigen binding fragment thereof is secukinumab.
3 . The method according to claim 2 , wherein the secukinumab dose according to step a) and b) is 300 mg.
4 . The method according to either claim 3 , wherein, prior to treatment with secukinumab, the patient had an inadequate response to, had failure to, or was intolerant to treatment with a Tumor Necrosis Factor (TNF)-alpha antagonist.
5 . A method of treating ankylosing spondylitis (AS) in a patient, comprising administering about 300 mg secukinumab by subcutaneous injection to the patient at weeks 0, 1, 2, 3 and 4, followed by about 300 mg of secukinumab every four weeks.
6 . The method according to claim 5 , wherein the patient has active AS.
7 . The method according to claim 5 , wherein the patient has moderate to severe active AS.
8 . The method according to claim 5 , further comprising administering an NSAID or methotrexate to the patient.
9 . The method according to claim 5 , wherein the patient previously had an inadequate response to treatment with at least one NSAID.
10 . The method according to claim 5 , wherein the patient is a DMARD failure.
11 . The method according to claim 5 , wherein, prior to treatment with secukinumab, the patient had an inadequate response to, had failure to, or was intolerant to treatment with a TNF-alpha antagonist.
12 . The method according to claim 6 , wherein, prior to treatment with secukinumab, the patient had an inadequate response to, had failure to, or was intolerant to treatment with a TNF-alpha antagonist.
13 . The method according to claim 7 , wherein, prior to treatment with secukinumab, the patient had an inadequate response to, had failure to, or was intolerant to treatment with a TNF-alpha antagonist.
14 . The method according to claim 8 , wherein, prior to treatment with secukinumab, the patient had an inadequate response to, had failure to, or was intolerant to treatment with a TNF-alpha antagonist.
15 . The method according to claim 9 , wherein, prior to treatment with secukinumab, the patient had an inadequate response to, had failure to, or was intolerant to treatment with a TNF-alpha antagonist.
16 . The method according to claim 10 , wherein, prior to treatment with secukinumab, the patient had an inadequate response to, had failure to, or was intolerant to treatment with a TNF-alpha antagonist.
17 . The method according to claim 5 , wherein secukinumab is comprised in a pharmaceutical formulation, wherein said pharmaceutical formulation further comprises a buffer and a stabilizer.
18 . The method according to claim 17 , wherein the pharmaceutical formulation is in liquid form.
19 . The method according to claim 18 , wherein the liquid formulation is disposed in a pre-filled syringe, injection pen, or autoinjector, and further wherein the liquid formulation comprises trehalose, histidine buffer, and polysorbate 80.
20 . The method according to claim 17 , wherein the pharmaceutical formulation is in lyophilized form.
21 . The method according to claim 20 , wherein the lyophilisate formulation is disposed in a vial, and further wherein the lyophilisate formulation comprises sucrose, histidine buffer, and polysorbate 80.
22 . The method according to claim 21 , wherein the lyophilsate formulation comprises 150 mg/mL secukinumab, 30 mM L-histidine, pH 5.8, 270 mM sucrose, and 0.06% polysorbate 80 after reconstitution.
23 . A method of treating active AS in a patient who has responded inadequately to previous treatment with at least one NSAID, comprising administering about 300 mg of secukinumab by subcutaneous injection to the patient at weeks 0, 1, 2, 3 and 4, followed by about 300 mg of secukinumab every four weeks.
24 . The method according to claim 17 , wherein, prior to treatment with secukinumab, the patient had an inadequate response to, had failure to, or was intolerant to treatment with a TNF-alpha antagonist.