{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Longbrake EE"],"funding":["Biogen","NCATS NIH HHS","NIAID NIH HHS","NINDS NIH HHS"],"pagination":["883-894"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8023410"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["27(6)"],"pubmed_abstract":["<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 a"],"journal":["Multiple sclerosis (Houndmills, Basingstoke, England)"],"pubmed_title":["Dimethyl fumarate treatment shifts the immune environment toward an anti-inflammatory cell profile while maintaining protective humoral immunity."],"pmcid":["PMC8023410"],"funding_grant_id":["UM1 AI110557","R01 NS080821","UL1 TR001863","K23 NS107624"],"pubmed_authors":["Zielinski T","Mao-Draayer Y","Mendoza JP","Cascione M","Xing D","Chen C","Brassat D","Bame E","Robertson D","Kapadia S","Miller C","Parks B","Longbrake EE"],"additional_accession":[]},"is_claimable":false,"name":"Dimethyl fumarate treatment shifts the immune environment toward an anti-inflammatory cell profile while maintaining protective humoral immunity.","description":"<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 a","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 May","modification":"2026-04-16T13:31:53.508Z","creation":"2022-02-10T11:41:55.755Z"},"accession":"S-EPMC8023410","cross_references":{"pubmed":["32716690"],"doi":["10.1177/1352458520937282"]}}