THERAPEUTIC TYROSINE KINASE INHIBITORS FOR MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY DISEASE (MOGAD)

1 . A method of treating myelin oligodendrocyte glycoprotein antibody disease (MOGAD), comprising administering to a subject in need thereof a therapeutically effective amount of a BTK inhibitor comprising (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one or a pharmaceutically acceptable salt thereof.

2 . A method of reducing the frequency of myelin oligodendrocyte glycoprotein antibody disease (MOGAD) relapse in a subject having MOGAD, comprising administering to a subject in need thereof a therapeutically effective amount of a BTK inhibitor comprising (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one or a pharmaceutically acceptable salt thereof.

3 . A method of reducing MOG antibody titers in a subject having myelin oligodendrocyte glycoprotein antibody disease (MOGAD), comprising administering to a subject in need thereof a therapeutically effective amount of a BTK inhibitor comprising (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one or a pharmaceutically acceptable salt thereof.

4 . The method of claim 1 , wherein the subject has at least one symptom of myelin oligodendrocyte glycoprotein antibody disease (MOGAD) prior to treatment.

5 . The method of claim 4 , wherein the at least one myelin oligodendrocyte glycoprotein antibody disease (MOGAD) symptom is chosen from loss of color vision, loss or blurring of vision, paralysis/paraparesis of limbs, and loss of bladder/bowel control.

6 . The method of claim 5 , wherein the treatment reduces or eliminates at least one symptom of myelin oligodendrocyte glycoprotein antibody disease (MOGAD).

7 . The method of claim 1 , wherein the subject is relapse-free about 1 year.

8 . The method of claim 1 , wherein the subject has at least one confirmed relapse in the previous 12 months or 2 confirmed relapses in the previous 24 months at screening.

9 . The method of claim 8 , wherein the subject in relapse is administered a corticosteroid.

10 . The method of claim 9 , wherein the corticosteroid is methylprednisone.

11 . The method of claim 1 , wherein a dose of about 5 mg to about 60 mg of the BTK inhibitor is administered.

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16 . The method of claim 1 , wherein the dose is once daily.

17 . The method of claim 1 , wherein the dose is administered once daily with food.

18 . The method of claim 1 , wherein the dose is 60 mg and is administered once daily with food.

19 . The method of claim 1 , wherein the BTK inhibitor compound is administered as monotherapy.

20 . The method of claim 1 , wherein myelin oligodendrocyte glycoprotein antibody disease (MOGAD) is chosen from acquired demyelinating syndromes (ADS).

21 . The method of claim 20 , wherein the acquired demyelinating syndrome (ADS) is acute disseminated encephalomyelitis (ADEM).

22 . The method of claim 1 , wherein the subject is a human.

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38 . A method of treating myelin oligodendrocyte glycoprotein antibody disease MOGAD) in a patient in need thereof, comprising administering a therapeutically effective amount BTK inhibitor comprising (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one or a pharmaceutically acceptable salt thereof to the patient, wherein the patient is not receiving potent and moderate inducers of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes.

39 . A method of treating myelin oligodendrocyte glycoprotein antibody disease MOGAD) in a patient in need thereof, comprising the steps of:

(a) advising the patient to limit alcohol consumption during treatment; and

(b) administering a therapeutically effective amount BTK inhibitor comprising (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one or a pharmaceutically acceptable salt thereof to the patient,

wherein the patient is female and is advised to limit alcohol consumption to 14 grams/day or less, or the patient is male and is advised to limit alcohol consumption to 28 grams/day or less.