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

Autor: Barry A. Singer, Sibyl Wray, Mark Gudesblatt, Barbara Bumstead, Tjalf Ziemssen, Ashley Bonnell, Matthew Scaramozza, Seth Levin, Mathura Shanmugasundaram, Hailu Chen, Jason P. Mendoza, James B. Lewin, Sai L. Shankar
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Neurology and Therapy, Vol 13, Iss 4, Pp 1273-1285 (2024)
Druh dokumentu: article
ISSN: 2193-8253
2193-6536
DOI: 10.1007/s40120-024-00637-2
Popis: Abstract 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
Databáze: Directory of Open Access Journals
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje