biostudies-literatureLongbrake EEBiogenNCATS NIH HHSNIAID NIH HHSNINDS NIH HHS883-894https://www.ebi.ac.uk/biostudies/studies/S-EPMC8023410biostudies-literatureUnknown27(6)<h4>Background</h4>Delayed-release dimethyl fumarate (DMF) demonstrates sustained efficacy and safety for relapsing forms of MS. Absolute lymphocyte count (ALC) is reduced initially, then stabilizes on treatment.<h4>Objective</h4>PROCLAIM, a 96-week, prospective, open-label, phase 3b study, assessed lymphocyte subsets and immunoglobulin (Ig) levels during 48 and 96 weeks (W) of DMF treatment.<h4>Methods</h4>Patients received 240 mg DMF BID. Endpoints: lymphocyte subset count changes (primary); Ig isotypes and ALC changes (secondary); adverse events and relationship between ALC changes and ARR/EDSS (exploratory); and neurofilament assessment (ad hoc).<h4>Results</h4>Of 218 patients enrolled, 158 (72%) completed the study. Median ALC decreased 39% from baseline to W96 (BL-W96), stabilizing aMultiple sclerosis (Houndmills, Basingstoke, England)Dimethyl fumarate treatment shifts the immune environment toward an anti-inflammatory cell profile while maintaining protective humoral immunity.PMC8023410UM1 AI110557R01 NS080821UL1 TR001863K23 NS107624Zielinski TMao-Draayer YMendoza JPCascione MXing DChen CBrassat DBame ERobertson DKapadia SMiller CParks BLongbrake EEfalseDimethyl fumarate treatment shifts the immune environment toward an anti-inflammatory cell profile while maintaining protective humoral immunity.<h4>Background</h4>Delayed-release dimethyl fumarate (DMF) demonstrates sustained efficacy and safety for relapsing forms of MS. Absolute lymphocyte count (ALC) is reduced initially, then stabilizes on treatment.<h4>Objective</h4>PROCLAIM, a 96-week, prospective, open-label, phase 3b study, assessed lymphocyte subsets and immunoglobulin (Ig) levels during 48 and 96 weeks (W) of DMF treatment.<h4>Methods</h4>Patients received 240 mg DMF BID. Endpoints: lymphocyte subset count changes (primary); Ig isotypes and ALC changes (secondary); adverse events and relationship between ALC changes and ARR/EDSS (exploratory); and neurofilament assessment (ad hoc).<h4>Results</h4>Of 218 patients enrolled, 158 (72%) completed the study. Median ALC decreased 39% from baseline to W96 (BL-W96), stabilizing a2021-01-01T00:00:00Z2021 May2026-04-16T13:31:53.508Z2022-02-10T11:41:55.755ZS-EPMC80234103271669010.1177/1352458520937282