Regimens and methods of treating multiple sclerosis using ofatumumab

Abstract

The disclosure is directed to treatment regimens for treating Multiple Sclerosis (MS). These methods utilize administration of ofatumumab, an anti-CD20 monoclonal antibody, to the patient during a loading dose regimen and a maintenance regimen.

1 - 18 . (canceled) 
     
     
         19 . A method of treating Multiple Sclerosis (MS) in a patient in need thereof, comprising administering ofatumumab to the patient in an initial loading dose regimen that attains B-cell depletion levels of ≤8 cells/μl in the patient, followed by a subsequent maintenance dose regimen that maintains B-cell depletion level of ≤8 cells/ul in the patient. 
     
     
         20 . The method of  claim 19 , wherein the initial loading dose regimen comprises 20 mg of ofatumumab administered at week 0 of the dosing regimen, 20 mg of ofatumumab administered week 1 of the dosing regimen, and 20 mg of ofatumumab administered week 2 of the dosing regimen, and the subsequent maintenance dose regimen comprises 20 mg of ofatumumab administered monthly starting at week 4 of the dosing regimen. 
     
     
         21 . The method of  claim 19 , wherein the initial loading dose regimen consists of 20 mg of ofatumumab administered at week 0 of the dosing regimen, 20 mg of ofatumumab administered week 1 of the dosing regimen, and 20 mg of ofatumumab administered week 2 of the dosing regimen, and the subsequent maintenance dose regimen consists of 20 mg of ofatumumab administered monthly starting at week 4 of the dosing regimen. 
     
     
         22 . The method of  claim 19 , wherein the initial loading dose regimen comprises 20 mg of ofatumumab administered on day 1 of the dosing regimen, 20 mg of ofatumumab administered on day 7 of the dosing regimen, and 20 mg of ofatumumab administered on day 14 of the dosing regimen, and the subsequent maintenance dose regimen comprises 20 mg ofatumumab administered monthly starting on day 28 of the dosing regimen. 
     
     
         23 . The method of any one of  claims 19 - 22 , wherein ofatumumab is formulated for administration by subcutaneous (s.c.) injection. 
     
     
         24 . The method of  claim 23 , wherein the administration is by a pre-filled syringe. 
     
     
         25 . The method of  claim 23 , wherein ofatumumab is formulated for self-administration. 
     
     
         26 . The method of  claim 25 , wherein the self-administration is by using an auto-injector. 
     
     
         27 . The method of  claim 23 , wherein the formulation comprises sodium acetate, sodium chloride, arginine, EDTA, and polysorbate 80, and the formulation has a pH of 5.0 to 7.0. 
     
     
         28 . The method of  claim 25 , wherein the formulation comprises sodium acetate, sodium chloride, arginine, EDTA, and polysorbate 80, and the formulation has a pH of 5.0 to 7.0. 
     
     
         29 . The method of any one of  claims 19 - 21 , wherein the ofatumumab is administered at a concentration of 50 mg/ml. 
     
     
         30 . A method for alleviating or delaying progression of the symptoms of Multiple Sclerosis (MS) in a patient, comprising administering ofatumumab to the patient in an initial loading dose regimen that attains B-cell depletion levels of ≤8 cells/ul in the patient, followed by a subsequent maintenance dose regimen that keeps B-cell depletion level of ≤8 cells/ul in the patient. 
     
     
         31 . A method for slowing progression of Multiple Sclerosis (MS) in a patient in need there of, comprising administering ofatumumab to the patient in an initial loading dose regimen that attains B-cell depletion levels of ≤8 cells/ul in the patient, followed by a subsequent maintenance dose regimen that maintains a B-cell depletion level of ≤8 cells/μl in the patient.