Treatment of multiple sclerosis (MS)

Patent metadata

Field	Value
Publication number	US-9498528-B2
Application number	US-90021107-A
Country	US
Kind code	B2
Filing date	Sep 10, 2007
Priority date	Sep 13, 2006
Publication date	Nov 22, 2016
Grant date	Nov 22, 2016

Abstract

A method for treatment of multiple sclerosis (MS) with Campath-1H with significant efficacy and a favorable safety profile is described, which offers an acceptable benefit/risk ratio. Especially described is the use of Campath-1H (alemtuzumab) for the production of a medicament for the treatment of multiple sclerosis (MS), comprising a first treatment cycle followed by at least one further treatment cycle of Campath-1H (alemtuzumab), in which each treatment cycle comprises 1-5 daily doses which are applied on consecutive days, wherein the daily dose is >0 and ≦12 mg, and wherein each treatment cycle is separated from the next cycle by at least 1-24 months. Also described are treatment regimens comprising the administration of less than 12 mg/day of Campath-1H for a period of 1-5 consecutive days.

First claim

What is claimed is:

1. A method of treating multiple sclerosis (MS) in a patient with a single MS immunotherapeutic consisting of an anti-CD52 antibody, the method comprising:
administering the anti-CD52 antibody to the patient at 1-12 mg/day for 1-5 days in an initial treatment cycle, and
at least 3 months after the initial treatment cycle, administering the anti-CD52 antibody to the patient at 1-12 mg/day for 1-5 days in a second treatment cycle.

2. The method of claim 1 , wherein the anti-CD52 antibody is administered to the patient at 12 mg/day in the initial treatment cycle and in the second treatment cycle.

3. The method of claim 1 or 2 , wherein the anti-CD52 antibody is administered to the patient for five consecutive days in the initial treatment cycle and three consecutive days in the second treatment cycle.

4. The method of claim 1 , wherein the period of time between the initial treatment cycle and the second treatment cycle is at least 12 months.

5. The method of claim 1 , wherein the patient has no renewed MS activity for at least 12 months after the second treatment cycle.

6. The method of claim 1 , wherein the 1-12 mg of the anti-CD52 antibody for each treatment day is administered to the patient via intravenous infusion.

7. The method of claim 1 , wherein the patient is pre-medicated with a steroid immediately prior to the anti-CD52 antibody administration on the first three days of each treatment cycle.

8. The method of claim 7 , wherein the steroid is methylprednisolone.

9. The method of claim 1 , wherein the anti-CD52 antibody is administered to the patient at less than 12 mg/day in the initial treatment cycle and in the second treatment cycle.

10. The method of claim 1 , wherein the patient is treated with acetaminophen or an antihistamine before, during or after treatment with the anti-CD52 antibody.

11. The method of claim 1 , further comprising administering the anti-CD52 antibody at 1-12 mg/day for 1-5 days in one or more subsequent treatment cycles after the second treatment cycle, if the patient has renewed MS activity after the second treatment cycle.

12. The method of claim 1 or 2 , wherein the anti-CD52 antibody is alemtuzumab.

13. The method of claim 1 , wherein the patient has previously been treated with an MS drug that is not an anti-CD52 antibody.

14. The method of claim 13 , wherein the patient has failed to respond to the previous MS treatment.

15. The method of claim 1 , wherein the patient has a relapsing form of MS.

16. The method of claim 15 , wherein the patient has relapsing-remitting MS.

17. The method of claim 15 , wherein the patient has active relapsing MS.

18. The method of claim 1 , wherein the patient is treated with a steroid before or during treatment with the anti-CD52 antibody.

19. The method of claim 1 , wherein the period of time between the initial treatment cycle and the second treatment cycle is at least 6 months.

20. The method of claim 1 , wherein the period of time between the initial treatment cycle and the second treatment cycle is at least 18 months.

21. The method of claim 1 , wherein the period of time between the initial treatment cycle and the second treatment cycle is at least 24 months.

22. A method of treating multiple sclerosis (MS) in a patient with a single MS immunotherapeutic consisting of alemtuzumab, the method comprising:
administering alemtuzumab to the patient at 12 mg/day for five consecutive days in an initial treatment cycle, and
12 months after the initial treatment cycle, administering alemtuzumab to the patient at 12 mg/day for three consecutive days in a second treatment cycle.

23. The method of claim 22 , wherein the 12 mg of alemtuzumab for each treatment day is administered to the patient via intravenous infusion.

24. The method of claim 22 , wherein the patient is pre-medicated with a steroid immediately prior to alemtuzumab administration for the first three days of each treatment cycle.

25. The method of claim 22 , wherein the patient has a relapsing form of MS.

26. A method of reducing the risk of relapse, or the risk of progression of clinically significant disability, in a multiple sclerosis (MS) patient with a single MS immunotherapeutic consisting of an anti-CD52 antibody, the method comprising:
administering the anti-CD52 antibody to the patient at 1-12 mg/day for 1-5 days in an initial treatment cycle, and
at least 3 months after the initial treatment cycle, administering the anti-CD52 antibody to the patient at 1-12 mg/day for 1-5 days in a second treatment cycle.

27. The method of claim 26 , wherein the anti-CD52 antibody is alemtuzumab.

28. The method of claim 26 , wherein the patient has a relapsing form of MS.

29. A method of treating multiple sclerosis (MS) in a patient with a single MS immunotherapeutic consisting of an anti-CD52 antibody, wherein the method comprises:
administering a total dose of 10-60 mg of the anti-CD52 antibody to the patient over 1-5 days in an initial treatment cycle, and
at least 3 months after the initial treatment cycle, administering a total dose of 10-60 mg of the anti-CD52 antibody to the patient over 1-5 days in a second treatment cycle.

30. The method of claim 29 , wherein the anti-CD52 antibody is alemtuzumab.

31. The method of claim 29 , wherein the patient has a relapsing form of MS.

32. The method of claim 22 , 26 , or 29 , wherein the patient has previously been treated with an MS drug that is not an anti-CD52 antibody.

33. The method of claim 32 , wherein the patient has failed to respond to the previous MS treatment.

34. The method of claim 22 , 26 , or 29 , wherein the patient has not received prior MS therapy.

35. The method of claim 26 or 29 , wherein the second treatment cycle is administered at least 12 months after the first treatment cycle.

36. The method of claim 22 , 26 , or 29 , wherein the patient is treated with a steroid to manage infusion-related side effects.

37. The method of claim 1 , 22 , 26 , or 29 , wherein the two treatment cycles stabilize or decrease progression of neurological disability.

38. The method of claim 1 , 22 , 26 , or 29 , wherein the two treatment cycles stabilize or reduce central nervous system lesions as detected by imaging.

39. The method of claim 22 , 26 , or 29 , further comprising administering the anti-CD52 antibody at 1-12 mg/day for 1-5 days in a further treatment cycle in response to renewed MS activity.

40. The method of claim 1 , 22 , 26 , or 29 , wherein the anti-CD52 antibody is administered to the patient in only the initial and second treatment cycles.

41. A method of treating a relapsing form of multiple sclerosis (MS) in a patient, the method comprising:
administering alemtuzumab to the patient at 12 mg/day for five consecutive days in an initial treatment cycle, and
12 months after the initial treatment cycle, administering alemtuzumab to the patient at 12 mg/day for three consecutive days in a second treatment cycle,
wherein the 12 mg of alemtuzumab for each treatment day is administered to the patient via intravenous infusion over a period of 4 hours, and
wherein

Assignees

• Margolin David H
• Hong Walter
• Coles Alasdair J
• Compston Alastair
• Shaked Ze'Ev
• Genzyme Corp
• Alcafleu Man Gmbh & Co Kg

Inventors

• Margolin David H
• Hong Walter
• Coles Alasdair J
• Compston Alastair
• Shaked Ze'Ev

Classifications

• C07K16/2893 Primary

  against CD52 · CPC title

• A61K2039/545

  characterised by the dose, timing or administration schedule · CPC title

• A61K2039/505

  comprising antibodies · CPC title

• A61K39/3955 Primary

  against proteinaceous materials, e.g. enzymes, hormones, lymphokines · CPC title