Granted Patent
B2
US 12,497,449 · App. 17/761,485 · Granted Dec 16, 2025
Methods of treating autoimmune diseases using interleukin-17 (IL-17) antagonists
Inventors:
Abhijit Bapat (Mountain Lakes, NJ); Thomas Dumortier (Basel, CH); Meryl Mendelson (Larchmont, NY); Shephard Mpofu (Oberwil, CH); Luminita Pricop (New York, NY)
Assignee:
NOVARTIS AG
C07K16/244A61K9/0019A61K31/42A61K31/4402A61K31/4706A61K31/519A61K31/573A61K38/13A61K39/3955A61P19/02A61K2039/505A61K2039/54A61K2039/545C07K2317/21C07K2317/76
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Abstract
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.
Claims (42)
1 . A method of treating active psoriatic arthritis (PsA) or active axial spondyloarthritis (axSpA) comprising intravenously administering to a patient in need thereof a dose of about 6 mg/kg secukinumab, followed by intravenously administering a dose of about 2 mg/kg secukinumab every 4 weeks.
2 . The method of claim 1 , wherein the patient has active PsA.
3 . The method of claim 2 , wherein the patient is an American College of Rheumatology (ACR) 50 responder by week 16 of treatment.
4 . The method of claim 2 , wherein the patient is an ACR20 responder by week 16 of treatment.
5 . The method of claim 2 , wherein the patient achieves Psoriasis Area and Severity Index (PASI) 75 by week 16 of treatment.
6 . The method of claim 2 , wherein the patient achieves PASI90 by week 16 of treatment.
7 . The method of claim 1 , wherein the patient has active axSpA.
8 . The method of claim 7 , wherein the patient achieves Assessment of SpondyloArthritis International Society (ASAS) 40 by week 16 of treatment.
9 . The method of claim 7 , wherein the patient achieves ASAS 20 by week 16 of treatment.
10 . The method of claim 7 , wherein the active axSpA is active ankylosing spondylitis (AS).
11 . The method of claim 10 , wherein the patient achieves an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C Reactive Protein (CRP) major improvement response by week 16 of treatment.
12 . The method of claim 10 , wherein the patient achieves an ASDAS-CRP inactive disease response by week 16 of treatment.
13 . The method of claim 7 , wherein the active axSpA in the patient is active non-radiographic axial spondyloarthritis (nr-axSpA).
14 . The method of claim 13 , wherein the patient achieves ASAS 40 by week 16 of treatment.
15 . The method of claim 13 , wherein the patient achieves ASAS 20 by week 16 of treatment.
16 . The method of claim 13 , wherein the patient achieves an ASDAS-CRP major improvement response by week 16 of treatment.
17 . The method of claim 1 , wherein secukinumab is supplied in a vial.
18 . The method of claim 1 , wherein secukinumab is supplied in a liquid composition comprising about 25 mg/mL secukinumab.
19 . The method of claim 1 , wherein secukinumab is 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.
20 . The method of claim 1 , wherein secukinumab is administered to the patient with an infusion duration of about 30 minutes.
21 . The method of claim 1 , wherein the patient is further intravenously administered a dose of about 3 mg/kg secukinumab every 4 weeks.
22 . A method of treating active psoriatic arthritis (PsA) or active axial spondyloarthritis (axSpA) comprising intravenously administering to a patient in need thereof a dose of about 2 mg/kg secukinumab every 4 weeks, wherein the patient has previously been intravenously administered a single loading dose of about 6 mg/kg secukinumab.
23 . The method of claim 22 , wherein the patient has active PsA.
24 . The method of claim 23 , wherein the patient achieves American College of Rheumatology (ACR) Criteria 50 by week 16 of treatment.
25 . The method of claim 23 , wherein the patient achieves ACR20 by week 16 of treatment.
26 . The method of claim 23 , wherein the patient achieves Psoriasis Area and Severity Index (PASI) 75 by week 16 of treatment.
27 . The method of claim 23 , wherein the patient achieves PASI90 by week 16 of treatment.
28 . The method of claim 22 , wherein the patient has active axSpA.
29 . The method of claim 28 , wherein the patient achieves Assessment of SpondyloArthritis International Society (ASAS) 40 by week 16 of treatment.
30 . The method of claim 28 , wherein the patient achieves ASAS 20 by week 16 of treatment.
31 . The method of claim 28 , wherein the active axSpA is active ankylosing spondylitis (AS).
32 . The method of claim 31 , wherein the patient achieves an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C Reactive Protein (CRP) major improvement response by week 16 of treatment.
33 . The method of claim 31 , wherein the patient achieves an ASDAS-CRP inactive disease response by week 16 of treatment.
34 . The method of claim 27 , wherein the active axSpA in the patient is active non-radiographic axial spondyloarthritis (nr-axSpA).
35 . The method of claim 34 , wherein the patient achieves ASAS 40 by week 16 of treatment.
36 . The method of claim 34 , wherein the patient achieves ASAS 20 by week 16 of treatment.
37 . The method of claim 34 , wherein the patient achieves an ASDAS-CRP major improvement response by week 16 of treatment.
38 . The method of claim 22 , wherein secukinumab is supplied in a vial.
39 . The method of claim 22 , wherein secukinumab is supplied in a liquid composition comprising about 25 mg/mL secukinumab.
40 . The method of claim 22 , wherein secukinumab is 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.
41 . The method of claim 22 , wherein secukinumab is administered to the patient with an infusion duration of about 30 minutes.
42 . The method of claim 22 , wherein the patient is intravenously administered a dose of about 3 mg/kg secukinumab every 4 weeks after the patient has been intravenously administered at least one dose of about 2 mg/kg secuinumab.
Assignments (8)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jun 11, 2026
From: NOVARTIS AG
To: NOVARTIS PHARMA AG
Reel/Frame 075712/0291 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 26, 2022
From: DUMORTIER, THOMAS; MPOFU, SHEPHARD
To: NOVARTIS PHARMA AG
Reel/Frame 060028/0850 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 26, 2022
From: MENDELSON, MERYL
To: NOVARTIS PHARMACEUTICALS CORPORATION
Reel/Frame 060029/0070 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 26, 2022
From: PRICOP, LUMINITA
To: NOVARTIS PHARMACEUTICALS CORPORATION
Reel/Frame 060029/0155 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 26, 2022
From: BAPAT, ABHIJIT
To: NOVARTIS PHARMACEUTICALS CORPORATION
Reel/Frame 060028/0442 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 26, 2022
From: NOVARTIS PHARMA AG
To: NOVARTIS AG
Reel/Frame 060029/0604 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 26, 2022
From: NOVARTIS PHARMA AG
To: NOVARTIS AG
Reel/Frame 060031/0378 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 26, 2022
From: NOVARTIS PHARMACEUTICALS CORPORATION
To: NOVARTIS AG
Reel/Frame 060029/0510 →
Continuity (3)
Provisional Application
62911394
· Oct 7, 2019
Provisional Application
62903070
· Sep 20, 2019
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