Methods Of Treating Multiple Sclerosis
The disclosure relates to methods of treating multiple sclerosis and maintaining or maximizing vaccine effectiveness. In certain aspects, the methods comprise administrating ponesimod, administering a vaccine, and interrupting the administration of the ponesimod.
1 . A method of treating multiple sclerosis (MS) and maximizing vaccine effectiveness, comprising:
administrating ponesimod to a patient in need thereof,
administering a vaccine to the patient, and
interrupting the administration of the ponesimod for a period of time.
2 . The method of claim 1 , wherein the ponesimod is administered prior to or concurrently with the administration of the vaccine.
3 . The method of claim 1 , wherein the ponesimod administration is interrupted prior to the administration of the vaccine and resumed after a period of time following the vaccine administration.
4 . A method of treating multiple sclerosis (MS) and maintaining vaccine effectiveness, comprising:
administrating ponesimod to a patient in need thereof; and
administering a vaccine to the patient.
5 . The method of claim 4 , wherein the ponesimod is administered prior to or concurrently with the administration of the vaccine.
6 . The method of claim 4 , wherein the ponesimod is administered prior to the administration of the vaccine.
7 . The method of claim 4 , wherein the method comprises no interruption of ponesimod administration prior to or after the vaccine administration.
8 . The method of claim 1 , wherein the ponesimod administration is interrupted for a period of time to allow for an antibody response.
9 . The method of claim 8 , wherein the antibody response is a positive or increased antibody concentration or an antibody response with low inhibition titers.
10 . The method of claim 1 , wherein the ponesimod administration is interrupted for about one to seven days.
11 . The method of claim 10 , wherein the ponesimod administration is interrupted for about 4 days.
12 . The method of claim 1 , wherein the ponesimod administration is interrupted for about six weeks.
13 . The method of claim 12 , wherein the ponesimod administration is interrupted for about six weeks starting from about one week prior to the administration of the vaccine.
14 . The method of claim 1 , wherein the ponesimod administration is interrupted for about five weeks.
15 . The method of claim 14 , wherein the ponesimod administration is interrupted for about five weeks starting from about one week prior to the administration of the vaccine.
16 . The method of claim 1 , wherein the ponesimod administration is interrupted for about four weeks.
17 . The method of claim 16 , wherein the ponesimod administration is interrupted for about four weeks starting from about one week prior to the administration of the vaccine.
18 . The method of claim 1 , wherein the ponesimod administration is interrupted for about three weeks.
19 . The method of claim 18 , wherein the ponesimod administration is interrupted for about three weeks starting from about one week prior to the administration of the vaccine.
20 . The method of claim 8 , wherein the administration of ponesimod is resumed after the interruption.
21 . The method of claim 1 , wherein about 20 mg of ponesimod is administered orally once daily.
22 . The method of claim 20 , wherein the resumption of the ponesimod administration comprises an up-titration, 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 administering 20 mg of ponesimod once daily thereafter.
23 . The method of claim 1 , wherein the MS is relapsing multiple sclerosis.
24 . The method of claim 23 , wherein the relapsing multiple sclerosis comprises relapsing-remitting disease, clinically isolated syndrome, or active secondary progressive disease.
25 . The method of claim 1 , wherein the vaccine is a flu vaccine.
26 . The method of claim 25 , wherein the flu vaccine comprises an inactivated H1N1 influenza virus.
27 . The method of claim 1 , wherein the vaccine is a COVID-19 vaccine.
28 . The method of claim 27 , wherein the COVID-19 vaccine comprises a non-live vaccine.
29 . The method of claim 28 , wherein the non-live vaccine is an mRNA vaccine, a protein subunit vaccine, a vector vaccine, or an inactivated vaccine.
30 . The method of claim 28 , wherein the non-live vaccine is an mRNA vaccine.
31 . A pharmaceutical product comprising ponesimod, wherein the pharmaceutical product is packaged, and the package includes instructions for treating MS and maintaining or maximizing vaccine effectiveness.
32 . The pharmaceutical product of claim 31 , wherein the vaccine is a COVID-19 vaccine or a flu vaccine.
33 . The pharmaceutical product of claim 31 , wherein the vaccine is a COVID-19 vaccine.
34 . The pharmaceutical product of claim 31 , wherein the vaccine is a flu vaccine.
35 . The method of claim 1 , wherein the patient has a pre-vaccination lymphocyte count <500 cells/mm 3 .
36 . The method of claim 1 , wherein the patient has a pre-vaccination lymphocyte count ≥500 cells/mm 3 .