Clinical evaluation of dimethyl fumarate for the treatment of relapsing-remitting multiple sclerosis: Efficacy, safety, patient experience and adherence

Bhavya Narapureddy, Divyanshu Dubey

Research output: Contribution to journalArticle

Abstract

Dimethyl fumarate (DMF) is an oral disease-modifying therapy approved for management of relapsing-remitting multiple sclerosis patients. Results from phase 3 clinical trials (DEFINE, CONFIRM) and follow-up study (ENDORSE) have provided good evidence for its efficacy and safety profile. Patient-reported outcomes (PROs) assessment revealed stabilization or boost in health-related quality of life and work productivity of patients treated with DMF compared to placebo reflecting a higher patient satisfaction to therapy. Being an oral agent with relatively favorable risk versus benefit profile DMF is commonly prescribed first-line agent. However, literature suggests that intolerance to side effects, especially gastrointestinal adverse effects and flushing is one of the major causes to compromised therapeutic compliance. An increase in the real-world incidence of progressive multifocal leukoencephalopathy and liver abnormality cases is also concerning. Several prevention and mitigation strategies like patient counseling, dose up-titration, pretreatment with aspirin, use of symptomatic therapy and frequent blood monitoring have demonstrated to be effective in tackling these adverse effects and promoting adherence to DMF. In this article, we review the efficacy, safety, PROs and patient adhere data, along with various measures to manage adverse events and promote compliance. Keywords: Dimethyl fumarate, multiple sclerosis, drug safety, patient adherence.

Original languageEnglish (US)
Pages (from-to)1655-1666
Number of pages12
JournalPatient Preference and Adherence
Volume13
DOIs
StatePublished - Jan 1 2019

Fingerprint

multiple sclerosis
Relapsing-Remitting Multiple Sclerosis
Patient Compliance
Safety
evaluation
experience
stabilization
Mouth Diseases
Patient Outcome Assessment
tolerance
counseling
quality of life
Progressive Multifocal Leukoencephalopathy
incidence
Therapeutics
productivity
Phase III Clinical Trials
monitoring
drug
Disease

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Social Sciences (miscellaneous)
  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Health Policy

Cite this

@article{8e40bcbf9b83481fa754ac03d6b36b06,
title = "Clinical evaluation of dimethyl fumarate for the treatment of relapsing-remitting multiple sclerosis: Efficacy, safety, patient experience and adherence",
abstract = "Dimethyl fumarate (DMF) is an oral disease-modifying therapy approved for management of relapsing-remitting multiple sclerosis patients. Results from phase 3 clinical trials (DEFINE, CONFIRM) and follow-up study (ENDORSE) have provided good evidence for its efficacy and safety profile. Patient-reported outcomes (PROs) assessment revealed stabilization or boost in health-related quality of life and work productivity of patients treated with DMF compared to placebo reflecting a higher patient satisfaction to therapy. Being an oral agent with relatively favorable risk versus benefit profile DMF is commonly prescribed first-line agent. However, literature suggests that intolerance to side effects, especially gastrointestinal adverse effects and flushing is one of the major causes to compromised therapeutic compliance. An increase in the real-world incidence of progressive multifocal leukoencephalopathy and liver abnormality cases is also concerning. Several prevention and mitigation strategies like patient counseling, dose up-titration, pretreatment with aspirin, use of symptomatic therapy and frequent blood monitoring have demonstrated to be effective in tackling these adverse effects and promoting adherence to DMF. In this article, we review the efficacy, safety, PROs and patient adhere data, along with various measures to manage adverse events and promote compliance. Keywords: Dimethyl fumarate, multiple sclerosis, drug safety, patient adherence.",
author = "Bhavya Narapureddy and Divyanshu Dubey",
year = "2019",
month = "1",
day = "1",
doi = "10.2147/PPA.S187529",
language = "English (US)",
volume = "13",
pages = "1655--1666",
journal = "Patient Preference and Adherence",
issn = "1177-889X",
publisher = "Dove Medical Press Ltd.",

}

TY - JOUR

T1 - Clinical evaluation of dimethyl fumarate for the treatment of relapsing-remitting multiple sclerosis

T2 - Efficacy, safety, patient experience and adherence

AU - Narapureddy, Bhavya

AU - Dubey, Divyanshu

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Dimethyl fumarate (DMF) is an oral disease-modifying therapy approved for management of relapsing-remitting multiple sclerosis patients. Results from phase 3 clinical trials (DEFINE, CONFIRM) and follow-up study (ENDORSE) have provided good evidence for its efficacy and safety profile. Patient-reported outcomes (PROs) assessment revealed stabilization or boost in health-related quality of life and work productivity of patients treated with DMF compared to placebo reflecting a higher patient satisfaction to therapy. Being an oral agent with relatively favorable risk versus benefit profile DMF is commonly prescribed first-line agent. However, literature suggests that intolerance to side effects, especially gastrointestinal adverse effects and flushing is one of the major causes to compromised therapeutic compliance. An increase in the real-world incidence of progressive multifocal leukoencephalopathy and liver abnormality cases is also concerning. Several prevention and mitigation strategies like patient counseling, dose up-titration, pretreatment with aspirin, use of symptomatic therapy and frequent blood monitoring have demonstrated to be effective in tackling these adverse effects and promoting adherence to DMF. In this article, we review the efficacy, safety, PROs and patient adhere data, along with various measures to manage adverse events and promote compliance. Keywords: Dimethyl fumarate, multiple sclerosis, drug safety, patient adherence.

AB - Dimethyl fumarate (DMF) is an oral disease-modifying therapy approved for management of relapsing-remitting multiple sclerosis patients. Results from phase 3 clinical trials (DEFINE, CONFIRM) and follow-up study (ENDORSE) have provided good evidence for its efficacy and safety profile. Patient-reported outcomes (PROs) assessment revealed stabilization or boost in health-related quality of life and work productivity of patients treated with DMF compared to placebo reflecting a higher patient satisfaction to therapy. Being an oral agent with relatively favorable risk versus benefit profile DMF is commonly prescribed first-line agent. However, literature suggests that intolerance to side effects, especially gastrointestinal adverse effects and flushing is one of the major causes to compromised therapeutic compliance. An increase in the real-world incidence of progressive multifocal leukoencephalopathy and liver abnormality cases is also concerning. Several prevention and mitigation strategies like patient counseling, dose up-titration, pretreatment with aspirin, use of symptomatic therapy and frequent blood monitoring have demonstrated to be effective in tackling these adverse effects and promoting adherence to DMF. In this article, we review the efficacy, safety, PROs and patient adhere data, along with various measures to manage adverse events and promote compliance. Keywords: Dimethyl fumarate, multiple sclerosis, drug safety, patient adherence.

UR - http://www.scopus.com/inward/record.url?scp=85073408481&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85073408481&partnerID=8YFLogxK

U2 - 10.2147/PPA.S187529

DO - 10.2147/PPA.S187529

M3 - Article

AN - SCOPUS:85073408481

VL - 13

SP - 1655

EP - 1666

JO - Patient Preference and Adherence

JF - Patient Preference and Adherence

SN - 1177-889X

ER -