Authors
Katherine E Selwa, Lana E Sharba, Preeta Gupta-Gardner, Carol A Janney, David J Johnson, Tiffany J Braley, Andrew R Romeo
Published in
Multiple sclerosis and related disorders. Volume 116. Pages 108021. Oct 27, 2026. Epub Oct 27, 2026.
Abstract
Lymphopenia is an expected side effect of fumarate-based multiple sclerosis (MS) disease modifying therapies. Although ≤5% of participants in fumarate clinical trials experienced grade 2-3 lymphopenia, real-world observation suggests higher incidence (Gold et al., 2012, 2020). Beyond increased age, consensus regarding risk factors for lymphopenia is lacking.
This retrospective chart review evaluated incidence and severity of lymphopenia among 274 patients treated with fumarates and examined associations between fumarate-associated lymphopenia and clinical variables with univariate and multivariate analyses.
Ninety (32.8%) patients developed grade ≥2 lymphopenia while on treatment. Absolute lymphocyte count (ALC) dropped by an average of 46% (SD 0.27) from baseline. Older age upon fumarate initiation was significantly associated with grade ≥2 lymphopenia (1.048 (95% CI=1.023, 1.074), p=0.0001). Other variables significantly associated with grade ≥2 lymphopenia included co-administration of dalfampridine (3.283 (95% CI=1.347, 8.003), p=0.0089). These associations were maintained in multivariate analysis. Among those who developed grade ≥2 lymphopenia, ALC recovered to ≥1.0 K/mL in 61%, with average time of 22 months (SD 23) after treatment discontinuation.
In this real-world clinical cohort, fumarate-associated lymphopenia incidence exceeds published estimates. Our findings support age as a risk factor and reveal unexpected associations between lymphopenia and co-use of dalfampridine that require further study.
PMID:
42966340
Bibliographic data and abstract were imported from PubMed on 01 Nov 2026.
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