Managing flushing and gastrointestinal events associated with delayed-release dimethyl fumarate: Experiences of an international panel

J. Theodore Phillips; Michael Hutchinson; Robert Fox; Ralf Gold; Eva Havrdova

doi:10.1016/j.msard.2014.03.003

Managing flushing and gastrointestinal events associated with delayed-release dimethyl fumarate: Experiences of an international panel

J. Theodore Phillips
, Michael Hutchinson
, Robert Fox
, Ralf Gold
, Eva Havrdova

Research output: Contribution to journal › Article › peer-review

39 Scopus citations

Abstract

Strategies for monitoring and managing the known adverse event (AE) profile of therapies for relapsing-remitting multiple sclerosis have become key to the optimization of patient outcomes. Delayed-release dimethyl fumarate (DMF) was associated with an increased risk of flushing and gastrointestinal (GI) AEs in clinical trials. A survey of clinicians with significant research experience using delayed-release DMF was conducted to provide guidance to clinicians using delayed-release DMF in clinical practice on the management of flushing and GI tolerability AEs. Recommendations for prophylaxis included educating the patient about flushing and GI AEs associated with delayed-release DMF and recommending administration with food. A variety of symptomatic treatments were utilized during the delayed-release DMF clinical trials in patients presenting with delayed-release DMF-related flushing or GI AEs that were severe or bothersome enough to warrant pharmacological intervention.

Original language	English
Pages (from-to)	513-519
Number of pages	7
Journal	Multiple Sclerosis and Related Disorders
Volume	3
Issue number	4
DOIs	https://doi.org/10.1016/j.msard.2014.03.003
State	Published - Jul 2014
Externally published	Yes

Keywords

Adverse events
Dimethyl fumarate
Flushing
Gastrointestinal adverse events
Multiple sclerosis
Tolerability

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10.1016/j.msard.2014.03.003

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@article{a8be9c312b2d49fc8b3bbdf380f5ece9,

title = "Managing flushing and gastrointestinal events associated with delayed-release dimethyl fumarate: Experiences of an international panel",

abstract = "Strategies for monitoring and managing the known adverse event (AE) profile of therapies for relapsing-remitting multiple sclerosis have become key to the optimization of patient outcomes. Delayed-release dimethyl fumarate (DMF) was associated with an increased risk of flushing and gastrointestinal (GI) AEs in clinical trials. A survey of clinicians with significant research experience using delayed-release DMF was conducted to provide guidance to clinicians using delayed-release DMF in clinical practice on the management of flushing and GI tolerability AEs. Recommendations for prophylaxis included educating the patient about flushing and GI AEs associated with delayed-release DMF and recommending administration with food. A variety of symptomatic treatments were utilized during the delayed-release DMF clinical trials in patients presenting with delayed-release DMF-related flushing or GI AEs that were severe or bothersome enough to warrant pharmacological intervention.",

keywords = "Adverse events, Dimethyl fumarate, Flushing, Gastrointestinal adverse events, Multiple sclerosis, Tolerability",

author = "Phillips, \{J. Theodore\} and Michael Hutchinson and Robert Fox and Ralf Gold and Eva Havrdova",

note = "Funding Information: J. Theodore Phillips has received honoraria from Acorda, Biogen Idec, Genzyme, Novartis, Sanofi, Teva Neuroscience, and Xenoport, and research support from Biogen Idec and Roche. Michael Hutchinson has received honoraria from Bayer HealthCare, Biogen Idec, and Novartis and editorial fees from the Multiple Sclerosis Journal. Robert Fox has received consultant fees from Allozyne, Avanir, Biogen Idec, Novartis, Questcor, Teva, and Xenoport; served on advisory committees for Biogen Idec and Novartis; and has received research grant funding from Novartis. Ralf Gold has received honoraria from Bayer HealthCare, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience and research support from Bayer HealthCare, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. Eva Havrdova has received honoraria from Bayer HealthCare, Biogen Idec, Genzyme, GlaxoSmithKline, Novartis, Merck Serono, Sanofi Aventis, and Teva Neuroscience and is supported by the Czech Ministry of Education (MSM 0021620849 and PRVOUK-P26/LF1/4). ",

year = "2014",

month = jul,

doi = "10.1016/j.msard.2014.03.003",

language = "English",

volume = "3",

pages = "513--519",

journal = "Multiple Sclerosis and Related Disorders",

issn = "2211-0348",

publisher = "Elsevier B.V.",

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T1 - Managing flushing and gastrointestinal events associated with delayed-release dimethyl fumarate

T2 - Experiences of an international panel

AU - Phillips, J. Theodore

AU - Hutchinson, Michael

AU - Fox, Robert

AU - Gold, Ralf

AU - Havrdova, Eva

N1 - Funding Information: J. Theodore Phillips has received honoraria from Acorda, Biogen Idec, Genzyme, Novartis, Sanofi, Teva Neuroscience, and Xenoport, and research support from Biogen Idec and Roche. Michael Hutchinson has received honoraria from Bayer HealthCare, Biogen Idec, and Novartis and editorial fees from the Multiple Sclerosis Journal. Robert Fox has received consultant fees from Allozyne, Avanir, Biogen Idec, Novartis, Questcor, Teva, and Xenoport; served on advisory committees for Biogen Idec and Novartis; and has received research grant funding from Novartis. Ralf Gold has received honoraria from Bayer HealthCare, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience and research support from Bayer HealthCare, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. Eva Havrdova has received honoraria from Bayer HealthCare, Biogen Idec, Genzyme, GlaxoSmithKline, Novartis, Merck Serono, Sanofi Aventis, and Teva Neuroscience and is supported by the Czech Ministry of Education (MSM 0021620849 and PRVOUK-P26/LF1/4).

PY - 2014/7

Y1 - 2014/7

N2 - Strategies for monitoring and managing the known adverse event (AE) profile of therapies for relapsing-remitting multiple sclerosis have become key to the optimization of patient outcomes. Delayed-release dimethyl fumarate (DMF) was associated with an increased risk of flushing and gastrointestinal (GI) AEs in clinical trials. A survey of clinicians with significant research experience using delayed-release DMF was conducted to provide guidance to clinicians using delayed-release DMF in clinical practice on the management of flushing and GI tolerability AEs. Recommendations for prophylaxis included educating the patient about flushing and GI AEs associated with delayed-release DMF and recommending administration with food. A variety of symptomatic treatments were utilized during the delayed-release DMF clinical trials in patients presenting with delayed-release DMF-related flushing or GI AEs that were severe or bothersome enough to warrant pharmacological intervention.

AB - Strategies for monitoring and managing the known adverse event (AE) profile of therapies for relapsing-remitting multiple sclerosis have become key to the optimization of patient outcomes. Delayed-release dimethyl fumarate (DMF) was associated with an increased risk of flushing and gastrointestinal (GI) AEs in clinical trials. A survey of clinicians with significant research experience using delayed-release DMF was conducted to provide guidance to clinicians using delayed-release DMF in clinical practice on the management of flushing and GI tolerability AEs. Recommendations for prophylaxis included educating the patient about flushing and GI AEs associated with delayed-release DMF and recommending administration with food. A variety of symptomatic treatments were utilized during the delayed-release DMF clinical trials in patients presenting with delayed-release DMF-related flushing or GI AEs that were severe or bothersome enough to warrant pharmacological intervention.

KW - Adverse events

KW - Dimethyl fumarate

KW - Flushing

KW - Gastrointestinal adverse events

KW - Multiple sclerosis

KW - Tolerability

UR - https://www.scopus.com/pages/publications/84902515818

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DO - 10.1016/j.msard.2014.03.003

M3 - Article

AN - SCOPUS:84902515818

SN - 2211-0348

VL - 3

SP - 513

EP - 519

JO - Multiple Sclerosis and Related Disorders

JF - Multiple Sclerosis and Related Disorders

IS - 4

ER -

Managing flushing and gastrointestinal events associated with delayed-release dimethyl fumarate: Experiences of an international panel

Abstract

Keywords

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