Method for treating autoimmune disease by IL-17 antagonist
The present application relates to a method for treating an autoimmune disease by an IL-17 antagonist. The present application relates to an application of an IL-17A binding agent in preparation of a drug for treating an autoimmune disease, such as rheumatoid arthritis, ankylosing spondylitis, and psoriasis, in particular, provides a method for treating inflammation or an autoimmune disease, comprising administering an effective amount of an IL-17 binding agent to a patient, wherein the administration frequency is less than once a week.
1 . A method for treating an inflammatory or autoimmune disease involving an IL-17A-mediated inflammatory response, comprising administering to a patient in need thereof an IL-17A binding agent at a dose of 40-300 mg with a frequency selected from once every four weeks and once every eight weeks,
wherein the IL-17A binding agent comprises a heavy chain variable region and a light chain variable region, and
the heavy chain variable region comprises HCDR1, HCDR2 and HCDR3 set forth in SEQ ID NOs: 7, 8 and 9, respectively; and the light chain variable region comprises LCDR1, LCDR2 and LCDR3 set forth in SEQ ID NOs: 10, 11 and 12, respectively.
2 . The method according to claim 1 , wherein the IL-17A binding agent is administered at a frequency of once every four weeks.
3 . The method according to claim 1 , wherein the IL-17A binding agent is administered at a dose of 80 mg, 120 mg, 160 mg, 200 mg or 240 mg.
4 . The method according to claim 1 , wherein the administration is performed orally, intravenously, or subcutaneously.
5 . The method according to claim 1 , wherein the method does not include a loading regimen, in which the IL-17A binding agent is administered at a frequency higher than once every four weeks in the initial stage of treatment.
6 . The method according to claim 1 , wherein the inflammatory or autoimmune disease is selected from psoriasis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis and inflammatory arthritis.
7 . The method according to claim 6 , wherein the patient has plaque psoriasis or moderate to severe plaque psoriasis.
8 . The method according to claim 7 , wherein the patient has or has not previously been treated with a systemic therapeutic agent for psoriasis prior to treatment with the IL-17A binding agent.
9 . The method according to claim 8 , wherein the systemic therapeutic agent is selected from methotrexate, cyclosporine, fumarate, acitretin, alefacept, adalimumab, efalizumab, etanercept, infliximab, golimumab and ustekinumab.
10 . The method according to claim 6 , wherein the patient has active psoriatic arthritis or the patient has co-existing psoriasis.
11 . The method according to claim 10 , wherein the patient is a TNFi failure or methotrexate failure and/or the patient further receives methotrexate.
12 . The method according to claim 6 , wherein the patient has moderate to severe active ankylosing spondylitis.
13 . The method according to claim 12 , wherein the patient is one who has previously been inadequately responsive to treatment with at least one NSAID and/or the patient further receives an NSAID, methotrexate, sulfasalazine, or prednisolone.
14 . The method according to claim 1 , wherein the IL-17A binding agent comprises a heavy chain framework region (FR) derived from a human germline heavy chain or a mutant sequence thereof, and a light chain framework region (FR) derived from a human germline light chain or a mutant sequence thereof.
15 . The method according to claim 1 , wherein the IL-17A binding agent is a humanized antibody comprising a heavy chain variable region set forth in SEQ ID NO: 3 or a variant thereof having 1-10 amino acid variations in the FR of the heavy chain variable region, and a light chain variable region set forth in SEQ ID NO: 4 or a variant thereof having 1-10 amino acid variations in the FR of the light chain variable region.
16 . The method according to claim 8 , wherein the amino acid variations in the heavy chain variable region are A93T and T71A; and/or the amino acid variations in the light chain variable region are F71Y, K49Y, Y36F and L47W.
17 . The method according to claim 1 , wherein the IL-17A binding agent comprises a light chain set forth in SEQ ID NO: 13 or a variant thereof, and a heavy chain set forth in SEQ ID NO: 14 or a variant thereof.
18 . The method according to claim 1 , wherein the IL-17A binding agent comprises a heavy chain constant region of human IgG1, IgG2, IgG3, or IgG4 isotype.