# US 2013/0156735 A1 · Use of the combination of teriflunomide and interferon beta for treating multiple sclerosis

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- Number: US 2013/0156735 A1
- Document ID: US20130156735A1
- Status: Published application
- Kind: A1
- Application number: 13/770,238
- Filed: 2013-02-19
- Published: 2013-06-20
- Earliest claimed: 2009-07-10
- Assignees: Sanofi-Aventis U.S. LLC
- Inventors: William BYRNES; Patrice DOUILLET; Gerald FRANGIN
- Web page: https://patentgrep.com/patent/US20130156735A1

## CPC

- A61K 38/215: {IFN-beta}
- A61K 31/165: having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K 31/277: having a ring, e.g. verapamil
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- 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
- 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

This invention is related to the use of the combination of teriflunomide and interferon beta thereof, for the preparation of a medicament for use in treating multiple sclerosis.

## Claims

### Claim 1

A method for treating relapsing-remitting form of multiple sclerosis, in a patient in need thereof, comprising administering to the patient about 7 mg or about 14 mg teriflunomide, and a pharmaceutically effective amount of interferon beta-1a or 1b.

### Claim 2 (depends on 1)

The method according to claim 1, comprising administering to the patient about 7 mg or about 14 mg teriflunomide once a day, and a stable dose of interferon beta-1a or 1b.

### Claim 3 (depends on 2)

The method according to claim 2, which is clinically proven effective.

### Claim 4

A method for reducing the number of T1-Gd lesions in a patient afflicted with relapsing-remitting form of multiple sclerosis comprising administering to the patient about 7 mg or about 14 mg teriflunomide, and a pharmaceutically effective amount of interferon beta-1a or 1b.

### Claim 5 (depends on 4)

The method according to claim 4, comprising administering to the patient about 7 mg or about 14 mg teriflunomide once a day, and a stable dose of interferon beta-1a or 1b.

### Claim 6 (depends on 5)

The method according to claim 5, which is clinically proven effective.

### Claim 7 (depends on 5)

The method according to claim 5, wherein the method reduces more T1-Gd lesions in the patient than when the patient is administered a stable dose of interferon beta-1a or 1b alone.

### Claim 8 (depends on 7)

The method according to claim 7, which is clinically proven effective.

### Claim 9 (depends on 5)

The method according to claim 5, which comprises administering to the patient about 7 mg teriflunomide once a day, and a stable dose of interferon beta-1a or 1b, wherein the number of T1-Gd lesions in the patients is reduced about 82.6% to about 84.6% comparing to the number of lesions in patients treated by a stable dose of interferon beta-1a or 1b alone.

### Claim 10 (depends on 5)

The method according to claim 5, which comprises administering to the patient about 14 mg teriflunomide once a day, and a stable dose of interferon beta-1a or 1b, wherein the number of T1-Gd lesions in the patients is reduced about 82.8% to about 84.4% comparing to the number of lesions in patients treated by a stable dose of interferon beta-1a or 1b alone.

### Claim 11

A method for reducing the volume of T1-Gd lesions in a patient afflicted with relapsing-remitting form of multiple sclerosis, comprising administering to the patient about 7 mg or about 14 mg teriflunomide once a day, and a stable dose of interferon beta-1a or 1b.

### Claim 12 (depends on 11)

The method according to claim 11, which is clinically proven effective.

### Claim 13 (depends on 11)

The method according to claim 11, wherein more volume of T1-Gd lesions is reduced in the patient treated by the method than in a patient treated by a stable dose of interferon beta-1a or 1b alone.

### Claim 14 (depends on 13)

The method according to claim 13, which comprises administering to the patients about 14 mg teriflunomide once a day, and a stable dose of interferon beta-1a or 1b, wherein more volumes of T1-Gd lesions are reduced in the patients than in patients treated by a stable dose of interferon beta-1a or 1b alone, and wherein the method is clinically proven effective.

### Claim 15 (depends on 11)

The method according to claim 11, which comprises administering to the patient about 14 mg teriflunomide once a day, and a stable dose of interferon beta-1a or 1b, wherein the volume of T1-Gd lesions in the patients treated by the method is reduced about 64.7% to about 70.6% comparing to the volume of lesions in patients treated by a stable dose of interferon beta-1a or 1b alone.