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Characterizing absolute lymphocyte count profiles in dimethyl fumarate-treated patients with MS: Patient management
Robert J Fox1, Andrew Chan1, Ralf Gold1
1Mellen Center for Multiple Sclerosis Treatment and Research (RJF), Cleveland Clinic, Cleveland, OH; St. Josef Hospital (AC, RG), Ruhr University, Bochum, Germany; Multiple Sclerosis Program (JTP), Baylor Institute for Immunology Research, Dallas, TX; Medical University of Lodz (KS), Lodz, Poland; and Biogen (IC, MN, JR, JLM), Cambridge, MA. Dr. Novas is currently with Alexion Pharmaceuticals, Chesire, CT; and Dr. Rana is currently with Sanofi-Genzyme, Cambridge, MA.
Background:
Delayed-release dimethyl fumarate (DMF), indicated for the treatment of patients with relapsing-remitting multiple sclerosis (MS), is a disease-modifying therapy with potential immunomodulatory and neuroprotective effects. In clinical trials, DMF was associated with reduced white blood cell and absolute lymphocyte counts. Current US prescribing information recommends obtaining a complete blood count, including absolute lymphocyte count (ALC), before initiating and during DMF treatment.
Methods:
We conducted an integrated analysis of phase 2b/3/long-term extension studies of DMF in MS (N = 2,470) to characterize ALC profiles.
Results:
Mean ALCs decreased by 30% during the first year and then plateaued, remaining above the lower limit of normal (LLN). Among patients treated ≥6 months (N = 2,099), 2.2% experienced ALCs <500 mm3 persisting ≥6 months. ALCs remained ≥LLN in 84% and 76% of patients during the first 6 and 12 months, respectively; of these, 0.1% and 0%, respectively, developed ALCs <500 mm3 persisting ≥6 months at any time. Evidence of ALC improvement following DMF discontinuation was observed. DMF efficacy was not substantially different in patients with and without lymphopenia.
Conclusion:
Lymphocyte monitoring provides effective means for early identification of patients at risk for developing severe, prolonged lymphopenia.
Insights
Delayed-release dimethyl fumarate (DMF) treatment for multiple sclerosis (MS) showed decreased absolute lymphocyte counts (ALC) that stabilized above normal levels. Monitoring ALC is key for identifying patients at risk of severe lymphopenia.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Dimethyl fumarate (DMF) is a disease-modifying therapy for relapsing-remitting multiple sclerosis (MS).
- DMF has demonstrated immunomodulatory and neuroprotective effects.
- Clinical trials noted reductions in white blood cell and absolute lymphocyte counts (ALC) with DMF use.
Purpose of the Study:
- To characterize absolute lymphocyte count (ALC) profiles in patients with MS treated with delayed-release DMF.
- To assess the incidence and duration of lymphopenia during DMF therapy.
Main Methods:
- Integrated analysis of phase 2b, 3, and long-term extension studies of DMF in MS.
- Included 2,470 patients to evaluate ALC changes over time.
Main Results:
- Mean ALCs decreased by 30% in the first year, then plateaued above the lower limit of normal (LLN).
- Only 2.2% of patients treated for ≥6 months experienced persistent ALCs <500 mm³ for ≥6 months.
- ALC improvement was observed after DMF discontinuation; DMF efficacy was not impacted by lymphopenia.
Conclusions:
- Lymphocyte monitoring is crucial for early detection of patients at risk for severe, prolonged lymphopenia.
- The findings support current recommendations for monitoring ALC during DMF treatment.
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