Methods of treating inflammatory and autoimmune diseases with alpha-4 inhibitory compounds
AssigneeElan Pharmaceuticals, Inc.
InventorIvan Lieberburg
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Abstract
Alpha 4 inhibitors are used in treatment of inflammatory and autoimmune diseases, such as multiple sclerosis, Crohn's Disease, rheumatoid arthritis and asthma. Rare occurrences of progressive multifocal leucoencephalopathy during treatment with an alpha-4 agent suggest the possibility that it may be related to such treatment. Monitoring for the JC virus and educating caregivers and patients about the manifestations of progressive multifocal leucoencephalopathy can improve the safety of alpha 4 inhibitor therapy.
Claims80
A method of using an alpha-4 inhibitor compound to treat a patient with an inflammatory, or autoimmune disease comprising:
- (a) administering a pharmaceutically effective amount of the alpha-4 inhibitor compound;
- (b) monitoring the patient for at least one indicator of progressive multifocal leukoencephalopathy;
- and
- (c) discontinuing administration of the alpha-4 inhibitor compound when at least one indicator of progressive multifocal leukoencephalopathy is present;
- wherein the monitoring improves safety of treatment;
- wherein the alpha-4 inhibitor compound is a compound of Formula V, a pharmaceutically acceptable salt or ester of any of the foregoing:
- wherein:
- R1 is selected from the group consisting of C1 to C4 alkyl and C1 to C4 haloalkyl;
- and
- R2 is selected from the group consisting of C1 to C4 alkyl, C2 to C4 alkenyl, C2 to C4 alkynyl, C3-C6 cycloalkyl and benzyl.
A method of using an alpha-4 inhibitor compound to treat a patient with an inflammatory or autoimmune disease comprising:
- (a) removing a sample of blood from the patient;
- (b) testing serum or plasma of the sample for IgG antibodies to JC virus;
- (c) initiating treatment of the patient with the alpha-4 inhibitor compound, if the sample is negative for IgG antibodies to JC virus;
- (d) monitoring the patient for at least one indicator of progressive multifocal leukoencephalopathy;
- and
- (e) discontinuing administration of the alpha-4 inhibitor compound when at least one indicator of progressive multifocal leukoencephalopathy is present;
- wherein the testing and monitoring improve safety of the treatment;
- wherein the alpha-4 inhibitor compound is a compound of Formula V, a pharmaceutically acceptable salt or ester of any of the foregoing:
- wherein:
- R1 is selected from the group consisting of C1 to C4 alkyl and C1 to C4 haloalkyl;
- and
- R2 is selected from the group consisting of C1 to C4 alkyl, C2 to C4 alkenyl, C2 to C4 alkynyl, C3-C6 cycloalkyl and benzyl.
A method of using an alpha-4 inhibitor compound to a patient with an inflammatory or autoimmune disease comprising:
- (a) removing a sample of blood from the patient;
- (b) testing serum or plasma of the sample for IgG antibodies to JC virus;
- (c) initiating treatment of the patient with the alpha-4 inhibitor compound, if the sample is positive for IgG antibodies to JC virus;
- (d) monitoring the patient for at least one indicator of progressive multifocal leukoencephalopathy;
- and
- (e) discontinuing administration of the alpha-4 inhibitor compound when at least one indicator of progressive multifocal leukoencephalopathy is present;
- wherein the testing and monitoring improves the safety of the treatment;
- wherein the alpha-4 inhibitor compound is a compound of Formula V, a pharmaceutically acceptable salt or ester of any of the foregoing:
- wherein:
- R1 is selected from the group consisting of C1 to C4 alkyl and C1 to C4 haloalkyl;
- and
- R2 is selected from the group consisting of C1 to C4 alkyl, C2 to C4 alkenyl, C2 to C4 alkynyl, C3-C6 cycloalkyl and benzyl.
A method of using an alpha-4 inhibitor compound to treat a patient with an inflammatory, or autoimmune disease comprising:
- (a) removing a sample of blood from the patient;
- (b) testing the sample for IgG antibodies to JC virus;
- (c) initiating treatment of the patient with the alpha-4 inhibitor compound, if the sample is positive for IgG antibodies to JC virus;
- (d) educating a prescribing physician about mental and physical symptoms of progressive multifocal leukoencephalopathy;
- (e) educating the patient about the mental and physical symptoms of progressive multifocal leukoencephalopathy and instructing the patient to report to the physician when at least one symptom is present;
- (f) monitoring the patient for at least one indicator of progressive multifocal leukoencephalopathy;
- and
- (g) discontinuing administration of alpha-4 inhibitor compound when at least one indicator of progressive multifocal leukoencephalopathy is present;
- wherein the testing, education, and monitoring improve safety of treatment;
- wherein the alpha-4 inhibitor compound is a compound of Formula V, a pharmaceutically acceptable salt or ester of any of the foregoing:
- wherein:
- R1 is selected from the group consisting of C1 to C4 alkyl and C1 to C4 haloalkyl;
- and
- R2 is selected from the group consisting of C1 to C4 alkyl, C2 to C4 alkenyl, C2 to C4 alkynyl, C3-C6 cycloalkyl and benzyl.
Dependencies are inferred from the claim text.