METHODS OF SLOWING AN INCREASE IN BRAIN VENTRICULAR VOLUME
The disclosure relates to methods of slowing an increase in brain ventricular volume. In certain aspects, methods of slowing an increase in brain ventricular volume in a patient with multiple sclerosis are disclosed.
1 . A method of slowing an increase in brain ventricular volume in a patient in need thereof, comprising administering ponesimod to the patient using a regimen that is effective to slow the increase in brain ventricular volume.
2 . The method of claim 1 , wherein the brain ventricular volume is determined by magnetic resonance imaging.
3 . The method of claim 1 , wherein the patient has multiple sclerosis (MS).
4 . The method of claim 1 , wherein the multiple sclerosis is relapsing multiple sclerosis.
5 . The method of claim 4 , wherein the relapsing multiple sclerosis comprises relapsing-remitting disease, clinically isolated syndrome or active secondary progressive disease.
6 . The method of claim 1 , wherein about 20 mg of ponesimod is administered orally once daily.
7 . The method of claim 1 , wherein the regimen comprises an up-titration step at initiation of the method or upon re-initiation of the method after a discontinuation, comprising administering orally once daily 2 mg of ponesimod on days 1 and 2: 3 mg of ponesimod on days 3 and 4: 4 mg of ponesimod on days 5 and 6: 5 mg of ponesimod on day 7: 6 mg of ponesimod on day 8: 7 mg of ponesimod on day 9; 8 mg of ponesimod on day 10; and 9 mg of ponesimod on day 11: 10 mg of ponesimod on days 12, 13, and 14, followed by the administering of the 20 mg of ponesimod once daily thereafter.
8 . The method of claim 1 , wherein the patient has a baseline expanded disability status scale (EDSS) score of less than or equal to 3.5.
9 . The method of claim 1 , wherein the patient has a baseline expanded disability status scale (EDSS) score of less than or equal to 3.
10 . The method of claim 1 , wherein slowing the increase in brain ventricular volume is relative to a patient population having substantially similar baseline disease characteristics and receiving a standard of care treatment that does not comprise ponesimod.
11 . The method of claim 10 , wherein the standard of care treatment comprises teriflunomide.
12 . The method of claim 10 , wherein the standard of care treatment comprises administration of about 14 mg of teriflunomide orally once daily.
13 . The method of claim 1 , wherein the relative slowing of the increase in ventricular volume is at least about 40%.
14 . The method of claim 1 , wherein the relative slowing of the increase in ventricular volume is at least about 60%.
15 . The method of claim 14 , wherein the relative slowing of the increase in ventricular volume results within about 60 weeks from initiation of treatment with ponesimod.
16 - 45 . (canceled)