# US 10,118,967 B2 · Methods for treating rheumatoid arthritis by administering IL-6 receptor antibodies

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- Number: US 10,118,967 B2
- Document ID: US10118967B2
- Status: Granted
- Kind: B2
- Application number: 14/904,864
- Filed: 2015-10-21
- Published: 2016-11-10
- Granted: 2018-11-06
- Earliest claimed: 2014-10-21
- Assignees: Ablynx N.V.
- Applicants: Ablynx N.V.
- Inventors: Sven Hoefman; Maria Laura Sargentini-Maier; Katrien Van Beneden
- Web page: https://patentgrep.com/patent/US10118967B2

## CPC

- C07K 16/2866: {against receptors for cytokines, lymphokines, interferons}
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/04: for non-specific disorders of the connective tissue
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 37/02: Immunomodulators
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/18: against material from animals or humans
- A61K 2039/505: {comprising antibodies}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- C07K 2317/31: multispecific
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/567: Framework region [FR]
- C07K 2317/569: Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- C07K 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance
- 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)
- 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

## Abstract

Methods are provided for the treatment of IL-6R related diseases. More specifically, specific dose regimens and pre-filled syringes are provided for subcutaneous administration, to subjects suffering an IL-6R related disease, of immunoglobulin single variable domains that bind IL-6R.

## Claims

### Claim 1

A method for the treatment of rheumatoid arthritis in a human subject, said method comprising administering, to a human subject suffering from the rheumatoid arthritis, a polypeptide consisting of the amino acid sequence of SEQ ID NO: 34, wherein the polypeptide is administered subcutaneously at a dose of 75-300 mg every week to every two weeks.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the polypeptide is administered every two weeks.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the polypeptide is administered at a dose of 75-150 mg.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the polypeptide is administered at a dose of 150-200 mg.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the polypeptide is administered at a dose of 150 mg.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the polypeptide is administered at a dose of 200-250 mg.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the polypeptide is administered at a dose of 225 mg.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the polypeptide is administered at a dose of 250-300 mg.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the polypeptide is administered at a dose of 300 mg.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the polypeptide is administered as a monotherapy.

### Claim 11 (depends on 1)

The method according to claim 1, wherein at least one additional therapeutic agent is administered.

### Claim 12 (depends on 11)

The method according to claim 11, wherein the additional therapeutic agent is selected from a disease-modifying antirheumatic drug (DMARD), methotrexate, a nonsteroidal anti-inflammatory drug (NSAID), a corticosteroid, and a biological therapeutic.

### Claim 13 (depends on 12)

The method according to claim 12, wherein methotrexate is administered at a dose of 12.5-25 mg weekly.