Lymphopenia is Not the Primary Therapeutic Mechanism of Diroximel Fumarate in Relapsing–Remitting Multiple Sclerosis: Subgroup Analyses of the EVOLVE-MS-1 Study

Introduction In EVOLVE-MS-1 (NCT02634307), mean absolute lymphocyte count (ALC) on diroximel fumarate (DRF) declined from baseline by approximately 28% in year 1, then stabilized, similar to ALC decline observed with dimethyl fumarate (DMF). Prior studies reported that clinical efficacy of DMF was n...

Full description

Saved in:
Bibliographic Details
Published in:Neurology and therapy 2024-08, Vol.13 (4), p.1273-1285
Main Authors: Singer, Barry A., Wray, Sibyl, Gudesblatt, Mark, Bumstead, Barbara, Ziemssen, Tjalf, Bonnell, Ashley, Scaramozza, Matthew, Levin, Seth, Shanmugasundaram, Mathura, Chen, Hailu, Mendoza, Jason P., Lewin, James B., Shankar, Sai L.
Format: Article
Language:English
Subjects:
Absolute lymphocyte count
Diroximel fumarate
Efficacy
Internal Medicine
Lymphopenia
Medicine
Medicine & Public Health
NCT
NCT02634307
Neurology
Original Research
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Introduction In EVOLVE-MS-1 (NCT02634307), mean absolute lymphocyte count (ALC) on diroximel fumarate (DRF) declined from baseline by approximately 28% in year 1, then stabilized, similar to ALC decline observed with dimethyl fumarate (DMF). Prior studies reported that clinical efficacy of DMF was not substantially different in patients with and without lymphopenia. Methods EVOLVE-MS-1—an open-label, 96-week, phase 3 study—assessed DRF safety and exploratory efficacy in patients with relapsing–remitting multiple sclerosis. This study analyzes efficacy-related outcomes comparing (1) patients with lymphopenia (≥ 1 ALC below lower limit of normal [LLN]) and without (all ALCs ≥ LLN); (2) across quartiles stratified by week 96 ALC decline from baseline: Q1 (≥ 47% decline); Q2 (30% to
ISSN:2193-8253
2193-6536
DOI:10.1007/s40120-024-00637-2