Treatment of multiple sclerosis (ms)

Abstract

A method for treatment of multiple sclerosis (MS) with Campath-1H with significant efficacy and a favourable 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.

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 single MS immunotherapeutic to the patient at 1-12 mg/day over 1-5 days, thereby treating the MS in the patient with a single MS immunotherapeutic consisting of an anti-CD52 antibody. 
     
     
         2 . The method of  claim 1 , wherein the method comprises
 administering the single MS immunotherapeutic to the patient at 1-12 mg/day over 1-5 days in an initial treatment cycle, and   at least 3 months after the initial treatment cycle, administering the single MS immunotherapeutic to the patient at 1-12 mg/day over 1-5 days in a second treatment cycle.   
     
     
         3 . The method of  claim 2 , wherein the period of time between the initial treatment cycle and the second treatment cycle is selected from: at least 6 months, at least 12 months, at least 18 months, and at least 24 months. 
     
     
         4 . The method of  claim 1 , wherein the patient has previously been treated with an MS drug that is not an anti-CD52 antibody. 
     
     
         5 . The method of  claim 4 , wherein the patient has failed to respond to the previous MS treatment. 
     
     
         6 . The method of  claim 1 , wherein the patient has a relapsing form of MS. 
     
     
         7 . The method of  claim 6 , wherein the patient has relapsing-remitting MS. 
     
     
         8 . The method of  claim 1 , wherein the anti-CD52 antibody is alemtuzumab. 
     
     
         9 . The method of  claim 1 , wherein the patient is pre-medicated with a steroid immediately prior to the single MS immunotherapeutic administration on each day of the administration. 
     
     
         10 . The method of  claim 1 , further comprising administering the MS immunotherapeutic at 1-12 mg/day over 1-5 days in a further treatment cycle in response to renewed MS activity. 
     
     
         11 . The method of  claim 2 , wherein the method comprises:
 administering a single MS immunotherapeutic consisting of an anti-CD52 antibody 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 the single MS immunotherapeutic consisting of an anti-CD52 antibody to the patient at 12 mg/day for three consecutive days in a second treatment cycle,   wherein the 12 mg of the single MS immunotherapeutic consisting of an anti-CD52 antibody for each treatment day is administered to the patient via intravenous infusion over a period of four hours,   wherein the patient is pre-medicated with a steroid immediately prior to the single MS immunotherapeutic consisting of an anti-CD52 antibody administration for the first three days of each treatment cycle, and   wherein the anti-CD52 antibody is alemtuzumab.   
     
     
         12 . A method of reducing the lymphocyte count for at least 12 months in a patient with a single MS immunotherapeutic consisting of an anti-CD52 antibody, the method comprising administering the single MS immunotherapeutic to the patient at a dose of 1-12 mg/day over 1-5 days, thereby treating the MS in the patient with a single MS immunotherapeutic consisting of an anti-CD52 antibody. 
     
     
         13 . A method of treating MS in a patient who has previously been treated with an MS drug that is not an anti-CD52 antibody, the method comprising:
 administering an anti-CD52 antibody to the patient at 1-12 mg/day over 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 over 1-5 days in a second treatment cycle.   
     
     
         14 . The method of  claim 13 , wherein the period of time between the initial treatment cycle and the second treatment cycle is selected from: at least 6 months, at least 12 months, at least 18 months, and at least 24 months. 
     
     
         15 . The method of  claim 13 , wherein the patient has no renewed MS activity for at least 12 months after the second treatment cycle. 
     
     
         16 . The method of  claim 13 , wherein the 1-12 mg of the anti-CD52 antibody for each treatment day is administered to the patient via intravenous infusion over a period of four hours. 
     
     
         17 . The method of  claim 13 , wherein the patient is pre-medicated with a steroid immediately prior to the anti-CD52 antibody administration on each day of each treatment cycle. 
     
     
         18 . The method of  claim 17 , wherein the steroid is methylprednisolone. 
     
     
         19 . The method of  claim 18 , wherein the methylprednisolone is administered to the patient at 1 g/day intravenously for each day of each treatment cycle. 
     
     
         20 . The method of  claim 13 , wherein the patient is medicated with acetaminophen or an antihistamine. 
     
     
         21 . The method of  claim 13 , further comprising administering the anti-CD52 antibody at 1-12 mg/day over 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. 
     
     
         22 . The method of  claim 13 , wherein the anti-CD52 antibody is alemtuzumab. 
     
     
         23 . The method of  claim 13 , wherein the patient has had a relapse during or after the previous MS treatment. 
     
     
         24 . The method of  claim 13 , wherein the patient has failed to respond to the previous MS treatment. 
     
     
         25 . The method of  claim 13 , wherein the patient has a relapsing form of MS. 
     
     
         26 . The method of  claim 25 , wherein the patient has relapsing-remitting MS. 
     
     
         27 . The method of  claim 25 , wherein the patient has active relapsing MS. 
     
     
         28 . The method of  claim 13 , wherein the patient is treated with a steroid before or during treatment with the anti-CD52 antibody. 
     
     
         29 . The method of  claim 13 , wherein the method comprises:
 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 four hours, and   wherein the patient is pre-medicated with a steroid immediately prior to alemtuzumab administration for the first three days of each treatment cycle.   
     
     
         30 . A method of reducing the risk of relapse, or the risk of progression of clinically significant disability, in an MS patient who has previously been treated with an MS drug that is not an anti-CD52 antibody, the method comprising:
 administering the anti-CD52 antibody to the patient at 1-12 mg/day over 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 over 1-5 days in a second treatment cycle.