Multiple Sclerosis Treatment Regimen Using Dimethyl Fumarate
Provided herein are methods of treating multiple sclerosis with dimethyl fumarate using an up-titration regimen. The methods provided herein are to reduce dimethyl fumarate-related gastro-intestinal adverse events in multiple sclerosis patients.
1 . A method of treating a human patient with multiple sclerosis comprising orally administering to the patient a pharmaceutical composition comprising dimethyl fumarate (hereinafter “DMF”); wherein the administering step comprises administering a starting dose of 120 mg DMF daily for 2 weeks, followed by 240 mg DMF daily for 2 weeks, followed by 360 mg DMF daily for 2 weeks, followed by 480 mg DMF daily as a maintenance dose.
2 . The method of claim 1 , wherein the 240 mg DMF daily is 120 mg DMF BID.
3 . The method of claim 1 or 2 , wherein the 360 mg DMF daily is 240 mg DMF in the morning and 120 mg DMF in the evening.
4 . The method of any of claims 1 - 3 , wherein the 480 mg DMF daily is 240 mg DMF BID.
5 . A method of treating a human patient with multiple sclerosis comprising orally administering to the patient a pharmaceutical composition comprising DMF; wherein the administering step comprises administering a starting dose of 120 mg DMF daily for 2 weeks, followed by 120 mg DMF BID for 2 weeks, followed by 360 mg DMF daily for 2 weeks, followed by 240 mg DMF BID as a maintenance dose; wherein the 360 mg DMF daily is 240 mg DMF in the morning and 120 mg DMF in the evening.
6 . The method of any of claims 1 - 5 , wherein the administering results in a reduced incidence of gastrointestinal adverse events compared to a dosing regimen in which the dose is increased to 240 mg DMF BID immediately following a starting dose of 120 mg DMF BID for one week.
7 . The method of any of claims 1 - 6 , wherein the pharmaceutical composition comprises DMF and a pharmaceutically acceptable carrier.
8 . The method of claim 7 , wherein the pharmaceutical composition is in the form of a tablet or a capsule.
9 . The method of claim 7 , wherein the pharmaceutical composition is in the form of an enterically coated tablet.
10 . The method of claim 7 , wherein the pharmaceutical composition is in the form of a capsule containing enterically coated microtablets.
11 . The method of any of claims 1 - 10 , wherein the pharmaceutical composition consists essentially of DMF.
12 . The method of any of claims 1 - 10 , wherein the pharmaceutical composition does not contain a fumarate salt.
13 . The method of any of claims 1 - 10 , wherein the pharmaceutical composition does not contain ethyl hydrogen fumarate salt.
14 . The method of any of claims 1 - 10 , wherein the pharmaceutical composition does not contain ethyl hydrogen fumarate calcium salt, ethyl hydrogen fumarate magnesium salt, ethyl hydrogen fumarate zinc salt, and ethyl hydrogen fumarate copper salt.
15 . The method of any of claims 1 - 14 , wherein the multiple sclerosis is a relapsing form of multiple sclerosis.