METHODS OF TREATING AUTOIMMUNE DISEASES USING INTERLEUKIN-17 (IL-17) ANTAGONISTS
The present disclosure relates to methods for treating patients having autoimmune diseases, e.g., methods for treating psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), e.g., non-radiographic axial spondyloarthritis (nr-axSpA) or ankylosing spondylitis (AS), using IL-17 antagonists, e.g., IL-17 antibodies, such as secukinumab. Also disclosed herein are methods for inhibiting the progression of structural damage in PsA and axSpA patients using IL-17 antagonists, e.g., IL-17 antibodies, such as secukinumab. The present disclosure also provides medicaments, pharmaceutical formulations, dosage forms, and kits for use in the disclosed methods.
1 - 53 . (canceled)
54 . A method of treating active PsA or active axial spondyloarthritis (axSpA) comprising intravenously administering to a patient in need thereof a dose of 2 mg/kg+/−10% secukinumab every 4 weeks.
55 . The method of claim 54 , wherein the patient has active PsA.
56 . The method of claim 55 , wherein the patient achieves American College of Rheumatology (ACR) Criteria 50 by week 16 of treatment.
57 . The method of claim 55 , wherein the patient achieves ACR20 by week 16 of treatment.
58 . The method of claim 55 wherein the patient achieves Psoriasis Area and Severity Index (PASI) 75 by week 16 of treatment.
59 . The method of claim 55 , wherein the patient achieves PASI90 by week 16 of treatment.
60 . The method of claim 54 , wherein the active PsA or active axSpA is active axSpA.
61 . The method of claim 60 , wherein the active axSpA is active ankylosing spondylitis (AS).
62 . The method of claim 61 , wherein the patient achieves Assessment of SpondyloArthritis International Society (ASAS) 40 by week 16 of treatment.
63 . The method of claim 61 , wherein the patient achieves an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C Reactive Protein (CRP) major improvement response by week 16 of treatment.
64 . The method of claim 61 , wherein the patient achieves an ASDAS-CRP inactive disease response by week 16 of treatment.
65 . The method of claim 61 , wherein the patient achieves ASAS 20 by week 16 of treatment.
66 . The method of claim 60 , wherein the axSpA in the patient is active non-radiographic axial spondyloarthritis (nr-axSpA).
67 . The method of claim 66 , wherein the patient achieves ASAS 40 by week 16 of treatment.
68 . The method of claim 66 , wherein the patient achieves an ASDAS-CRP major improvement response by week 16 of treatment.
69 . The method of claim 66 , wherein the patient achieves ASAS 20 by week 16 of treatment.
70 . The method of claim 54 , wherein secukinumab has been supplied in a vial.
71 . The method of claim 54 , wherein secukinumab has been supplied in a liquid composition comprising about 25 mg/mL secukinumab.
72 . The method of claim 54 , wherein secukinumab has been supplied in a liquid composition comprising about 25 mg/mL secukinumab, 225 mM trehalose, about 0.02% polysorbate 80, about 5 mM L-methionine, and about 20 mM histidine buffer, pH about 5.8.
73 . The method of claim 71 , wherein secukinumab is administered to the patient with an infusion duration of about 30 minutes.
74 . The method of claim 71 , wherein the patient is intravenously administered a dose of about 3 mg/kg secukinumab every four weeks after the patient has previously been intravenously administered a dose of 2 mg/kg+/−10% secukinumab every four weeks.
75 . A method of treating hidradenitis suppurativa comprising intravenously administering to a patient in need thereof a loading dose of about 5 mg/kg secukinumab, followed by a maintenance dose.
76 . The method of claim 75 , wherein the maintenance dose is lower than the loading dose.
77 . The method of claim 75 , wherein the patient is administered a maintenance dose starting on week 6.
78 . The method of claim 75 , wherein the patient is administered a maintenance dose on week 8.