# US 10,765,724 B2 · Method of treating psoriasis with increased interval dosing of anti-IL12/23 antibody

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,765,724 B2
- Document ID: US10765724B2
- Status: Granted
- Kind: B2
- Application number: 15/471,790
- Filed: 2017-03-28
- Published: 2018-02-08
- Granted: 2020-09-08
- Earliest claimed: 2016-03-29
- Assignees: Janssen Biotech, Inc.
- Applicants: Janssen Biotech, Inc.
- Inventors: Marc Chevrier; Kamyar Farahi; Newman Yeilding
- Web page: https://patentgrep.com/patent/US10765724B2

## CPC

- A61K 38/208: {IL-12}
- A01K 67/0271: Chimeric vertebrates, e.g. comprising exogenous cells
- A61K 38/20: Interleukins [IL]
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 25/00: Drugs for disorders of the nervous system
- 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 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 14/5434: {IL-12}
- C07K 16/244: {Interleukins [IL]}
- A61K 35/12: Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells (vaccines or medicinal preparations containing antigens or antibodies A61K39/00)
- A61K 2035/122: {for inducing tolerance or supression of immune responses}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/507: {Comprising a combination of two or more separate antibodies}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- C07K 16/24: against cytokines, lymphokines or interferons
- 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 2317/55: Fab or Fab'
- 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)
- A01K: ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- 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

A method of treating an IL-12/23-related disease in a patient using an increasing dosing interval, comprises increasing the dosing interval of IL-12/IL-23 antibody to a patient, wherein the antibody is administered initially and after 4 weeks, after 16 weeks and after 28 weeks, and increasing the dosing interval after 28 weeks to an increased interval, e.g., every 16, 20 or 24 weeks.

## Claims

### Claim 1

A method of treating psoriasis in a a patient using an increasing dosing or maintenance interval, comprising administering a pharmaceutical composition comprising an antibody to both IL-12 and IL-23 to the patient, wherein the antibody comprises a heavy chain variable amino acid sequence of SEQ ID NO: 7 and a light chain variable amino acid sequence of SEQ ID NO: 8, in an initial dose, a dose 4 weeks after the initial dose and a dose once every 12 weeks for 24 weeks after administration of the initial dose and increasing the dosing interval 28 weeks after administration of the initial dose to a dosing interval of every 24 weeks after identifying the patient as a responder to the antibody 28 weeks after administration of the initial dose, wherein the dose is 45 mg or 90 mg.

### Claim 2 (depends on 1)

The method of claim 1, wherein the step of identifying the patient as a responder to the antibody comprises measuring and identifying the patient as having a PASI75 or PGA 0 or 1 score.

### Claim 3 (depends on 1)

The method of claim 1, wherein the antibody to IL-12 and IL-23 administered to the patient is ustekinumab.

### Claim 4 (depends on 1)

The method of claim 1, wherein the patient does not show an increased risk of immunogenicity.

### Claim 5 (depends on 1)

The method of claim 1, wherein the patient has a PASI75, PASI90 or PGA 0 or 1 score 28 weeks after initial treatment.

### Claim 6 (depends on 1)

The method of claim 1, wherein the patient has a PASI75, PASI90 or PGA 0 or 1 score 52 weeks after initial treatment.

### Claim 7 (depends on 1)

The method of claim 1, wherein the patient has a PASI75, PASI90 or PGA 0 or 1 score 108, 112 and/or 116 weeks after initial treatment.

### Claim 8 (depends on 1)

The method of claim 1, wherein the antibody comprises the heavy chain variable region amino acid sequence of SEQ ID NO: 7 and the light chain variable region amino acid sequence of SEQ ID NO: 8 and comprises about 0.53 mg L-histidine per ml of the pharmaceutical composition; about 1.37 mg L-histidine monohydrochloride monohydrate per ml of the pharmaceutical composition; about 0.04 mg polysorbate 80 per ml of the pharmaceutical composition; about 76 mg of sucrose per ml of the pharmaceutical composition; and water as a diluent at standard state.

### Claim 9

A method of treating psoriasis in a patient using an a increasing dosing or maintenance interval, comprising administering a pharmaceutical composition comprising an antibody to both IL-12 and IL-23 to the patient in an initial dose, a dose 4 weeks after the initial dose and a dose once every 12 weeks for 24 weeks after administration of the initial dose and increasing the dosing interval 28 weeks after administration of the initial dose to a dosing interval of every 24 weeks after identifying the patient as a responder to the antibody 28 weeks after administration of the initial dose, wherein the dose is 45 mg or 90 mg, and wherein the antibody comprises the heavy chain CDR amino acid sequences of SEQ ID NO: 1, SEQ ID NO: 2, and SEQ ID NO: 3; and the light chain CDR amino acid sequences of SEQ ID NO: 4, SEQ ID NO: 5, and SEQ ID NO: 6 and comprises about 0.53 mg L-histidine per ml of the pharmaceutical composition; about 1.37 mg L-histidine monohydrochloride monohydrate per ml of the pharmaceutical composition; about 0.04 mg polysorbate 80 per ml of the pharmaceutical composition; about 76 mg of sucrose per ml of the pharmaceutical composition; and water as a diluent at standard state.