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Patient outcomes influenced by reduced lymphocyte counts after dimethyl fumarate initiation
Katy Wright1, Mandy D Winkler1, Braeden D Newton1
1UT Southwestern Medical Center (K.W., M.D.W., B.D.N., D.T.O.), Department of Neurology and Neurotherapeutics, Multiple Sclerosis and Neuroimmunology Imaging Program, Clinical Center for Multiple Sclerosis, Dallas, TX; and Department of Health Sciences (DISSAL) (M.P.S.), University of Genoa, Italy.
Objective:
To examine the temporal profile of absolute and lymphocyte subset data from dimethyl fumarate (DMF) start and relationships to disease behavior.
Methods:
A retrospective study performed on patients with an existing diagnosis of MS and a history of DMF exposure from a single MS center. Demographic, laboratory, and corresponding clinical relapse and MRI data were recorded from baseline and in 3-4-month intervals after treatment initiation extending to 3 years. The Spearman rank coefficient and mixed-effects models were used to assess longitudinal correlations between cell counts and measures of disease activity.
Results:
A total of 292 patients with MS (228 women; median age at DMF initiation: 40.6 years, range: 16.1-66.7 years) were identified. An increased risk of disease activity was associated with higher absolute lymphocyte count (ALC) values at 3 months (p = 0.001, OR: 1.82) and at 6 months (p = 0.032, hazard ratio: 1.73). A reduced risk of disease evolution in patients with lower ALC values < 1,200 cells/μL compared with midtier (1,210-1,800 cells/μL) and the highest tertile (>1,810 cells/μL) was observed (p = 0.01).
Conclusions:
Reductions in ALC values at months 3 and 6 after treatment initiation appear to be associated with improved clinical and radiologic outcomes. These data alone may help to provide a better understanding of both the safety and efficacy of DMF.