Dimethyl Fumarate and Vaccination Regimens

A method of treating or preventing a neurological disease or disorder in a subject in need thereof, comprising

• (a) administering to the subject a first dose of a pharmaceutical composition for a first dosing period, wherein the pharmaceutical composition comprises a fumarate agent selected from the group consisting of monomethyl fumarate, a compound that metabolizes into monomethyl fumarate in vivo, a deuterated analog thereof, a pharmaceutically acceptable salt thereof, and a combination thereof, wherein the subject receives a vaccine;
• (b) determining an immune response of the subject to the vaccine before the end of the first dosing period;
• and
• (c) administering to the subject a second dose of the pharmaceutical composition for a second dosing period, wherein the second dose is equal to or less than the first dose.

A method of treating or preventing a neurological disease or disorder in a subject who receives a vaccine, comprising:

• (a) screening a plurality of doses of a pharmaceutical composition comprising a fumarate agent selected from the group consisting of monomethyl fumarate, a compound that metabolizes into monomethyl fumarate in vivo, a deuterated analog thereof, a pharmaceutically acceptable salt thereof, and a combination thereof, by
• (1) identifying a first group of subjects and at least a second group of subjects, wherein both the first and second groups of subjects receive the vaccine while treated with the fumarate agent, wherein the first group of subjects is treated with a first dose of the fumarate agent, and the second group of subjects is treated with a second dose of the fumarate agent;
• (2) determining a lower risk dose;
• and
• (b) administering the lower risk dose of the pharmaceutical composition to the subject.

A method of treating or preventing multiple sclerosis in a subject in need thereof, comprising

• (a) determining a subject's baseline lymphocyte count prior to treatment;
• (b) administering to the subject a first dose of a pharmaceutical composition for a first dosing period, wherein the pharmaceutical composition comprises a fumarate agent selected from the group consisting of monomethyl fumarate, a compound that metabolizes into monomethyl fumarate in vivo, a deuterated analog thereof, a pharmaceutically acceptable salt thereof, and a combination thereof;
• (c) determining a subject's total lymphocyte count after the first dosing period;
• and
• (d) if the lymphocyte count after the first dosing period is about 90% of the baseline lymphocyte count or lower, do not administer tetanus diphtheria toxoids vaccine, keyhole limpet hemocyanin vaccine, pneumovax-23 vaccine, or any combinations thereof.