# US 12,594,333 B2 · Methods of treating inflammatory arthritis using IL-17 antagonists

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- Number: US 12,594,333 B2
- Document ID: US12594333B2
- Status: Granted
- Kind: B2
- Application number: 19/061,831
- Filed: 2025-02-24
- Published: 2025-06-26
- Granted: 2026-04-07
- Earliest claimed: 2010-11-05
- Assignees: Novartis AG
- Applicants: Novartis AG
- Inventors: Shephard Mpofu; Hanno Richards; Karthinathan Thangavelu; Matthias Machacek
- Web page: https://patentgrep.com/patent/US12594333B2

## CPC

- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 39/39591: {Stabilisation, fragmentation}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 37/00: Drugs for immunological or allergic disorders
- A61P 37/02: Immunomodulators
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/244: {Interleukins [IL]}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55: {characterised by the host/recipient, e.g. newborn with maternal antibodies}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/90: characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

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).

## Claims

### Claim 1

A method of treating an inflammatory arthritis associated with IL-17A, comprising administering to a patient in need thereof about 150 mg secukinumab by subcutaneous injection at each of weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.

### Claim 2 (depends on 1)

The method of claim 1, wherein the patient is a methotrexate (MTX)-failure, or disease-modifying anti-rheumatic drug (DMARD)-failure, or wherein the patient had an inadequate response to, had failure to, or was intolerant to treatment with a TNF alpha antagonist.

### Claim 3 (depends on 1)

The method of claim 1, wherein the inflammatory arthritis is selected from one or more of spondyloarthropathy, psoriatic arthritis, and polymyalgia rheumatica.

### Claim 4 (depends on 3)

The method of claim 3, wherein the inflammatory arthritis is spondyloarthropathy.

### Claim 5 (depends on 4)

The method of claim 4, wherein the patient is a methotrexate (MTX)-failure, or disease-modifying anti-rheumatic drug (DMARD)-failure, or wherein the patient had an inadequate response to, had failure to, or was intolerant to treatment with a TNF alpha antagonist.

### Claim 6 (depends on 4)

The method of claim 4, wherein the spondyloarthropathy is ankylosing spondylitis.

### Claim 7 (depends on 6)

The method of claim 6, wherein the patient is a methotrexate (MTX)-failure, or disease-modifying anti-rheumatic drug (DMARD)-failure, or wherein the patient had an inadequate response to, had failure to, or was intolerant to treatment with a TNF alpha antagonist.

### Claim 8 (depends on 3)

The method of claim 3, wherein the inflammatory arthritis is psoriatic arthritis.

### Claim 9 (depends on 8)

The method of claim 8, wherein the patient is a methotrexate (MTX)-failure, or disease-modifying anti-rheumatic drug (DMARD)-failure, or wherein the patient had an inadequate response to, had failure to, or was intolerant to treatment with a TNF alpha antagonist.

### Claim 10 (depends on 3)

The method of claim 3, wherein the inflammatory arthritis is polymyalgia rheumatica.

### Claim 11

A method of treating an inflammatory arthritis IL-17A, comprising administering to a patient in need thereof about 75 mg secukinumab by subcutaneous injection at each of weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.

### Claim 12 (depends on 11)

The method of claim 11, wherein the patient is a methotrexate (MTX)-failure, or disease-modifying anti-rheumatic drug (DMARD)-failure, or wherein the patient had an inadequate response to, had failure to, or was intolerant to treatment with a TNF alpha antagonist.

### Claim 13 (depends on 11)

The method of claim 11, wherein the patient weighs less than or equal to about 80 kg.

### Claim 14 (depends on 11)

The method of claim 11, wherein the inflammatory arthritis is spondyloarthropathy.

### Claim 15 (depends on 14)

The method of claim 14, wherein the patient is a methotrexate (MTX)-failure, or disease-modifying anti-rheumatic drug (DMARD)-failure, or wherein the patient had an inadequate response to, had failure to, or was intolerant to treatment with a TNF alpha antagonist.

### Claim 16 (depends on 14)

The method of claim 14, wherein the patient weighs less than or equal to about 80 kg.