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Characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with MS: Patient management considerations
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 c...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4909524/ https://www.ncbi.nlm.nih.gov/pubmed/27347439 http://dx.doi.org/10.1212/CPJ.0000000000000238 |
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author | Fox, Robert J. Chan, Andrew Gold, Ralf Phillips, J. Theodore Selmaj, Krzysztof Chang, Ih Novas, Mark Rana, Jitesh Marantz, Jing L. |
author_facet | Fox, Robert J. Chan, Andrew Gold, Ralf Phillips, J. Theodore Selmaj, Krzysztof Chang, Ih Novas, Mark Rana, Jitesh Marantz, Jing L. |
author_sort | Fox, Robert J. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4909524 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-49095242016-06-24 Characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with MS: Patient management considerations Fox, Robert J. Chan, Andrew Gold, Ralf Phillips, J. Theodore Selmaj, Krzysztof Chang, Ih Novas, Mark Rana, Jitesh Marantz, Jing L. Neurol Clin Pract Research 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. Lippincott Williams & Wilkins 2016-06 /pmc/articles/PMC4909524/ /pubmed/27347439 http://dx.doi.org/10.1212/CPJ.0000000000000238 Text en © 2016 American Academy of Neurology This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND) (http://creativecommons.org/licenses/by-nc-nd/4.0/) , which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially. |
spellingShingle | Research Fox, Robert J. Chan, Andrew Gold, Ralf Phillips, J. Theodore Selmaj, Krzysztof Chang, Ih Novas, Mark Rana, Jitesh Marantz, Jing L. Characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with MS: Patient management considerations |
title | Characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with MS: Patient management considerations |
title_full | Characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with MS: Patient management considerations |
title_fullStr | Characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with MS: Patient management considerations |
title_full_unstemmed | Characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with MS: Patient management considerations |
title_short | Characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with MS: Patient management considerations |
title_sort | characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with ms: patient management considerations |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4909524/ https://www.ncbi.nlm.nih.gov/pubmed/27347439 http://dx.doi.org/10.1212/CPJ.0000000000000238 |
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