Characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with MS

نویسندگان

  • Robert J. Fox
  • Andrew Chan
  • Ralf Gold
  • J. Theodore Phillips
  • Krzysztof Selmaj
  • Ih Chang
  • Mark Novas
  • Jitesh Rana
  • Jing L. Marantz
  • Zdeněk Ambler
  • Edvard Ehler
  • Eva Havrdova
  • Eva Meluzinova
  • Ivan Rektor
  • Radomir Talab
  • Hans-Peter Hartung
  • Attila Csanyi
  • László Csiba
  • Gábor Jakab
  • R.Q. Hintzen
  • Chris Polman
  • Wieslaw Drozdowski
  • Waldemar Fryze
  • Jan Kochanowicz
  • Hubert Kwiecinski
  • Zdzislaw Maciejek
  • Sebastian Schimrigk
  • Andrzej Szczudlik
  • Andrzej Wajgt
  • Anna Belova
  • Aleksey N Boiko
  • Alexander Elchaninov
  • Vladimir Kozlov
  • Miroslav M Odinak
  • Sergey B Shvarkov
  • Alexander Skoromets
  • Igor Stolyarov
  • Olga Vorobieva
  • Igor A Zavalishin
  • Jan Hillert
  • Tomas Olsson
  • Ludwig Kappos
  • Mefkure Eraksoy
  • Rana Karabudak
  • Aksel Siva
  • Gavin Giovannoni
  • Clive Hawkins
  • Mohammed Sharief
  • Basil Sharrack
  • C Confavreux
  • J Ware
  • Michael Barnett
  • Mark Paine
  • Jeannette Lechner-Scott
  • Roy Beran
  • Caron Chapman
  • Raymond Schwartz
  • Helmut Butzkueven
  • Reynolds Casse
  • Richard Macdonell
  • Thomas Berger
  • Franz Fazekas
  • Gerhard Ransmayr
  • Karl Vass
  • Shibeshih Belachew
  • Peter Paul De Deyn
  • Danny Decoo
  • Bénédicte Dubois
  • Robert Medaer
  • Pierrette Seeldrayers
  • Christian Sindic
  • Luc Vande Gaer
  • Ludo Vanopdenbosch
  • Sanja Grgic
  • Amit Bar-Or
  • Virender Bhan
  • Jean-Pierre Bouchard
  • Suzanne Christie
  • Pierre Grammond
  • François Jacques
  • Felix Veloso
  • Galina Vorobeychik
  • Vesna Brinar
  • Vida Demarin
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  • Petr Kanovsky
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  • Hans-Christoph Diener
  • Ilonka Eisensehr
  • Peter Emrich
  • Bernd Griewing
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  • Christoph Heesen
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  • Wilfried Lüer
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چکیده

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.

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عنوان ژورنال:

دوره 6  شماره 

صفحات  -

تاریخ انتشار 2016