Methods and compositions for treating complement-associated disorders

Abstract

The present disclosure relates to, inter alia, compositions containing an inhibitor of human complement and use of the compositions in methods for treating or preventing complement-associated disorders. In some embodiments, the inhibitor is chronically administered to patients. In some embodiments, the inhibitor is administered to a patient in an amount and with a frequency to maintain systemic complement inhibition and prevent breakthrough. In some embodiments, the compositions contain an antibody, or antigen-binding fragment thereof, that binds to a human complement component C5 protein or a fragment of the protein such as C5a or C5b.

1 - 93 . (canceled) 
     
     
         94 - 128 . (canceled) 
     
     
         129 . A method for treating myasthenia gravis (MG) in an anti-AChR antibody positive patient, the method comprising administering eculizumab to a patient in need thereof in an amount effective to treat MG in the patient; wherein the administration schedule of eculizumab comprises the following:
 at least 600 mg of eculizumab once per week for the first four consecutive weeks of treatment; and   a maintenance dose of at least 900 mg of eculizumab every two weeks.   
     
     
         130 . The method of  claim 129 , wherein the eculizumab is administered to the patient in an amount and with a frequency to maintain at least 50 μg of eculizumab per milliliter of the patient's blood. 
     
     
         131 . The method of  claim 129 , wherein the eculizumab is administered to the patient in an amount and with a frequency to maintain at least 100 μg of eculizumab per milliliter of the patient's blood. 
     
     
         132 . The method of  claim 129 , wherein the patient exhibits a substantial improvement in at least two symptoms of MG during the first four weeks of treatment. 
     
     
         133 . The method of  claim 129 , wherein the maintenance dose of eculizumab is administered every two weeks until the patient's MG is in remission. 
     
     
         134 . A method for treating myasthenia gravis (MG) in an anti-AChR antibody positive patient, the method comprising administering eculizumab to a patient in need thereof in an amount effective to treat MG in the patient; wherein the eculizumab is intravenously administered to the patient under the following schedule:
 900 mg of eculizumab once per week for four consecutive weeks;   1200 mg of eculizumab on the fifth week; and   1200 mg of eculizumab every two weeks thereafter.   
     
     
         135 . The method of  claim 134 , wherein the eculizumab is administered to the patient in an amount and with a frequency to maintain at least 50 μg of eculizumab per milliliter of the patient's blood. 
     
     
         136 . The method of  claim 134 , wherein the eculizumab is administered to the patient in an amount and with a frequency to maintain at least 100 μg of eculizumab per milliliter of the patient's blood. 
     
     
         137 . The method of  claim 134 , wherein the patient exhibits a substantial improvement in at least two symptoms of MG during the first four weeks of treatment. 
     
     
         138 . The method of  claim 134 , wherein the maintenance dose of eculizumab is administered every two weeks until the patient's MG is in remission.