METHOD FOR TREATING MULTIPLE SCLEROSIS PATIENTS WITH ANTI-IL2R ANTIBODIES
Methods are disclosed for using anti-IL-2R antibodies for the treatment of MS patients. In certain embodiments, the patients have neutralizing antibodies to IFN-beta.
1 . A method of treating MS patients that have neutralizing antibodies to interferon beta comprising, administering a therapeutically effective amount of anti-IL-2R antibody to the patients, thereby ameliorating a symptom of multiple sclerosis and treating the subject.
2 . The method according to claim 1 , wherein the MS patients have a IFN-beta neutralizing antibody titer greater than 20 in two or more consecutive samples.
3 . The method according to claim 1 , wherein the MS patients have a IFN-beta neutralizing antibody titer greater than 25 in two or more consecutive samples.
4 . The method according to claim 1 , wherein the anti-IL-2R antibody is daclizumab.
5 . The method according to claim 1 , wherein ameliorating a symptom of multiple sclerosis comprises reducing the number of relapses in a given period.
6 . The method according to claim 1 , wherein ameliorating a symptom of multiple sclerosis comprises reducing the rate of increase of the subject's Expanded Disability Status Score.
7 . The method according to claim 1 , wherein ameliorating a symptom of multiple sclerosis comprises reducing the number of T1 gadolinium contrast-enhanced MRI lesions.
8 . The method according to claim 1 , wherein ameliorating a symptom of multiple sclerosis comprises reducing the number of T2 gadolinium contrast-enhanced MRI lesions.
9 . The method of claim 1 , wherein daclizumab is administered at a dose of about 0.5 to about 5 milligrams per kilogram.
10 . The method of claim 5 , wherein daclizumab is administered at a dose of about 0.5 to about 1.5 milligrams per kilogram.
11 . The method of claim 5 , wherein daclizumab is administered at a dose of about 1 to about 1.5 milligrams per kilogram.
12 . The method of claim 5 , wherein daclizumab is administered at a dose of about 1 to about 2 milligrams per kilogram.
13 . The method of claim 5 , wherein daclizumab is administered at a dose of about 2 to about 4 milligrams per kilogram.
14 . The method of claim 5 , wherein daclizumab is administered intravenously.
15 . The method of claim 5 , wherein daclizumab is administered subcutaneously.
16 . The method of claim 1 , wherein daclizumab is administered at least biweekly.
17 . The method of claim 1 , wherein daclizumab is administered at least monthly.
18 . The method of claim 1 , wherein the subject has relapsing-remitting multiple sclerosis.
19 . The method of claim 1 , wherein the subject has secondary progressive multiple sclerosis.
20 . The method of claim 1 , wherein the subject has progressive relapsing multiple sclerosis.
21 . The method of claim 1 , wherein the subject has primary progressive multiple sclerosis.
22 . A method of treating an MS patient, the method comprising
a. determining whether a biological sample from an MS patient contains neutralizing interferon beta antibody; and
b. if the biological sample contains neutralizing interferon beta antibody, administering to the patient a therapeutically effective amount of anti-IL-2R antibody, thereby ameliorating at least one symptom of multiple sclerosis.
23 . The method according to claim 22 , wherein the MS patient has an IFN-beta neutralizing antibody titer greater than 20 in two or more consecutive samples or the MS patient has an IFN-beta neutralizing antibody titer greater than 25 in two or more consecutive samples.
24 . The method according to claim 22 , wherein the anti-IL-2R antibody is daclizumab.
25 . The method according to claim 22 , wherein ameliorating a symptom of multiple sclerosis comprises reducing the number of relapses in a given period, reducing the rate of increase of the subject's Expanded Disability Status Score, reducing the number of T1 gadolinium contrast-enhanced MRI lesions, or reducing the number of T2 gadolinium contrast-enhanced MRI lesions.
26 . The method of claim 24 , wherein daclizumab is administered at a dose of about 0.5 to about 5 milligrams per kilogram, daclizumab is administered at a dose of about 0.5 to about 1.5 milligrams per kilogram, daclizumab is administered at a dose of about 1 to about 1.5 milligrams per kilogram, daclizumab is administered at a dose of about 1 to about 2 milligrams per kilogram, or daclizumab is administered at a dose of about 2 to about 4 milligrams per kilogram.
27 . The method of claim 24 , wherein daclizumab is administered intravenously.
28 . The method of claim 24 , wherein daclizumab is administered subcutaneously.
29 . The method of claim 22 , wherein daclizumab is administered at least biweekly or at least monthly.
30 . The method of claim 22 , wherein the subject has relapsing-remitting multiple sclerosis, progressive relapsing multiple sclerosis, or primary progressive multiple sclerosis.