- Patent Number:
11498,975
- Appl. No:
17/007451
- Application Filed:
August 31, 2020
- نبذة مختصرة :
The present invention provides a method of treating insulin-dependent diabetes mellitus in a subject, comprising administering to the subject a therapeutically effective amount of a Janus kinase inhibitor, or a pharmaceutically acceptable salt or ester thereof, or a therapeutically effective amount of intravenous immunoglobulin, or a therapeutically effective amount of a therapeutic agent that destroys B lymphocytes, or a combination thereof. The present invention also provides kits containing the same.
- Inventors:
Levit, Eyal (Brooklyn, NY, US)
- Claim:
1. A method of treating insulin-dependent diabetes mellitus in a subject, comprising administering to the subject tofacitinib citrate; and administering to the subject intravenous immunoglobulin; and administering to the subject rituximab.
- Claim:
2. The method of claim 1 , wherein the tofacitinib citrate is administered at a dose from 4 mg to 64 mg per day; and wherein the intravenous immunoglobulin is administered at a dose of from 0.2 mg to 100 mg per kg weight of the subject every 1 to 4 weeks; and wherein the rituximab is administered at a dose of from 50 mg/m 2 to 700 mg/m 2 surface of the subject every 1 to 4 weeks.
- Claim:
3. The method of claim 2 , wherein the tofacitinib citrate is administered as immediate-release tablet or extended-release tablet comprising from 2 mg to 30 mg tofacitinib citrate; and wherein the intravenous immunoglobulin is administered as a sterile solution for injection comprising from 2%-50% protein; and wherein the rituximab is administered intravenously at a concentration of 0.2 mg/mL to 20 mg/mL.
- Claim:
4. The method of claim 3 , wherein the tofacitinib citrate is administered at a dose from about 8 mg to about 32 mg per day as an immediate-release tablet comprising about 8 mg tofacitinib citrate or as an extended-release tablet comprising about 17.77 mg tofacitinib citrate or both; and wherein the intravenous immunoglobulin is administered as a sterile solution for injection comprising from 5%-20% protein at a dose of from 1 mg to 2 mg per kg weight of the subject every 1 to 4 weeks; and wherein the rituximab is administered intravenously at a concentration of 1 mg/mL to 4 mg/mL at a dose of 375 mg/m 2 surface of the subject once per week.
- Claim:
5. The method of claim 4 , wherein the tofacitinib citrate is administered at a dose of 32 mg per day as an immediate-release tablet comprising about 8 mg tofacitinib citrate; and wherein the intravenous immunoglobulin is administered at a dose of 1 mg per kg weight of the subject every 3 weeks for a total of 5 to 6 months, and wherein intravenous immunoglobulin is administered at a dose of 2 mg per kg weight of the subject on a first day of treatment followed by doses of 1 mg per kg weight of the subject on second and third days of treatment; and wherein the rituximab is administered for a period of three weeks.
- Claim:
6. A method of treating insulin-dependent diabetes mellitus in a subject, comprising administering to the subject tofacitinib citrate; and administering to the subject intravenous immunoglobulin, and optionally a therapeutically effective amount of a therapeutic agent that destroys B lymphocytes.
- Claim:
7. The method of claim 6 , wherein the tofacitinib citrate is administered at a dose from 4 mg to 64 mg per day; and wherein the intravenous immunoglobulin is administered at a dose of from 0.2 mg to 100 mg per kg weight of the subject every 1 to 4 weeks.
- Claim:
8. The method of claim 7 , wherein the tofacitinib citrate is administered as immediate-release tablet or extended-release tablet comprising from 2 mg to 30 mg tofacitinib citrate; and wherein the intravenous immunoglobulin is administered as a sterile solution for injection comprising from 2%-50% protein.
- Claim:
9. The method of claim 8 , wherein the tofacitinib citrate is administered at a dose from about 8 mg to about 32 mg per day as an immediate-release tablet comprising about 8 mg tofacitinib citrate or as an extended-release tablet comprising about 17.77 mg tofacitinib citrate or both; and wherein the intravenous immunoglobulin is administered as a sterile solution for injection comprising from 5%-20% protein at a dose of from 1 mg to 2 mg per kg weight of the subject every 1 to 4 weeks.
- Claim:
10. The method of claim 9 , wherein the tofacitinib citrate is administered at a dose of 32 mg per day as an immediate-release tablet comprising about 8 mg tofacitinib citrate; and wherein the intravenous immunoglobulin is administered at a dose of 1 mg per kg weight of the subject every 3 weeks for a total of 5 to 6 months, and wherein intravenous immunoglobulin is administered at a dose of 2 mg per kg weight of the subject on a first day of treatment followed by doses of 1 mg per kg weight of the subject on second and third days of treatment.
- Claim:
11. The method of claim 6 , wherein therapeutically effective amounts of tofacitinib citrate, and intravenous immunoglobulin, and rituximab are administered.
- Claim:
12. The method of claim 6 , wherein therapeutically effective amounts of tofacitinib citrate and intravenous immunoglobulin, are administered.
- Claim:
13. The method of claim 6 , wherein the subject is in need of treatment.
- Claim:
14. The method of claim 6 , wherein the antibody agent is an anti-CD20 antibody agent.
- Claim:
15. The method of claim 14 , wherein the anti-CD20 antibody agent comprises amino acid sequences substantially identical to the CDRs of rituximab.
- Patent References Cited:
10759865 September 2020 Levit
- Primary Examiner:
Gembeh, Shirley V
- Attorney, Agent or Firm:
Kramer Levin Naftalis & Frankel LLP
- الرقم المعرف:
edspgr.11498975
Processing Request
No Comments.