Fox, Robert J; Chan, Andrew; Gold, Ralf; Phillips, J Theodore; Selmaj, Krzysztof; Chang, Ih; Novas, Mark; Rana, Jitesh; Marantz, Jing L (2016). Characterizing absolute lymphocyte count profiles in dimethyl fumarate-treated patients with MS: Patient management considerations. Neurology. Clinical practice, 6(3), pp. 220-229. American Academy of Neurology 10.1212/CPJ.0000000000000238
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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 mm(3) 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 mm(3) 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.
Item Type: |
Journal Article (Original Article) |
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Division/Institute: |
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DCR Unit Sahli Building > Forschungsgruppe Neurologie 04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology |
UniBE Contributor: |
Chan, Andrew Hao-Kuang |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
2163-0402 |
Publisher: |
American Academy of Neurology |
Language: |
English |
Submitter: |
Stefanie Hetzenecker |
Date Deposited: |
03 May 2017 10:43 |
Last Modified: |
02 Mar 2023 23:28 |
Publisher DOI: |
10.1212/CPJ.0000000000000238 |
PubMed ID: |
27347439 |
BORIS DOI: |
10.7892/boris.94722 |
URI: |
https://boris.unibe.ch/id/eprint/94722 |
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