# US 11,110,149 B2 · Method for predicting and monitoring the efficacy of low-dose IL-2 and hydroxychloroquine therapy in autoimmune diseases and its long-term use in autoimmune-related conditions

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- Number: US 11,110,149 B2
- Document ID: US11110149B2
- Status: Granted
- Kind: B2
- Application number: 16/794,585
- Filed: 2020-02-19
- Published: 2020-08-20
- Granted: 2021-09-07
- Earliest claimed: 2019-02-20
- Assignees: Ksl Biomedical LLC
- Applicants: Ksl Biomedical Inc.
- Inventors: Jing He; Zhanguo Li
- Web page: https://patentgrep.com/patent/US11110149B2

## CPC

- A61K 38/2013: {IL-2}
- A61K 31/4706: 4-Aminoquinolines; 8-Aminoquinolines, e.g. chloroquine, primaquine
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- 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

A method of inhibiting or treating systemic lupus erythematosus (SLE) and/or primary Sjögren's Syndrome (pSS) in a subject in need thereof is disclosed. The method calls for administering to the subject a therapeutically effective low-dose amount of interleukin-2 and hydroxychloroquine alone or in combination with a therapeutically effective amount of another disease-modifying antirheumatic drug. That combination results in inhibiting or treating SLE and/or pSS in the subject.

## Claims

### Claim 1

A method of inhibiting or treating systemic lupus erythematosus (SLE) in a subject in need thereof, the method consisting of administering to the subject a therapeutically effective low-dose amount of interleukin-2 in combination with a therapeutically effective amount of hydroxychloroquine, thereby inhibiting or treating SLE in the subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein said administering is administering no more than 24 weeks.

### Claim 3 (depends on 2)

The method of claim 2, wherein said administering is administering no more than 12 weeks.

### Claim 4 (depends on 1)

The method of claim 1, wherein the subject is a human.

### Claim 5 (depends on 1)

The method of claim 1, wherein the low-dose of interleukin-2 is 0.1 MIU/day to 3.5 MIU/day.

### Claim 6 (depends on 1)

The method of claim 1, wherein the low-dose of interleukin-2 is 0.1 MIU/every other day to 3.5 MIU/every other day.

### Claim 7

A method of inhibiting or treating primary Sjogren's syndrome (pSS) in a subject in need thereof, the method consisting of administering to the subject a therapeutically effective low-dose amount of interleukin-2 in combination with a therapeutically effective amount of hydroxychloroquine, thereby inhibiting or treating pSS in the subject.

### Claim 8 (depends on 7)

The method of claim 7, wherein said administering is administering no more than 24 weeks.

### Claim 9 (depends on 8)

The method of claim 8, wherein said administering is administering no more than 12 weeks.

### Claim 10 (depends on 7)

The method of claim 7, wherein the subject s a human.

### Claim 11 (depends on 7)

The method of claim 7, wherein the low-dose of interleukin-2 is 0.1 MIU/day to 3.5 MIU/day.

### Claim 12 (depends on 7)

The method of claim 7, wherein the low-dose of interleukin-2 is 0.1 MIU/every other day to 3.5 MIU/every other day.