Real-life persistence and tolerability with dimethyl fumarate

Tobias Sejbaek, Mads Nybo, Thor Petersen, Zsolt Illes

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Abstract

Background: Dimethyl fumarate (DMF) has been registered for the treatment of relapsing-remitting multiple sclerosis (RRMS). Differences in tolerability between multiple sclerosis clinics in patients treated with DMF has not been examined. Aim: We examined real-world tolerability to DMF, and also compared adherence data between two MS clinics. Methods: Adverse events (AE), discontinuation rates, and causes of discontinuation were investigated. Results: 253 patients participated in this retrospective study. In the total cohort, 27.7% of the patients discontinued DMF. Higher rate of discontinuation was associated with higher number of previous disease modifying treatments (p < 0.001). Reasons for discontinuation were primarily flushing (15%) and gastrointestinal AEs (51%). Grade III lymphopenia was detected only in 6 cases (2.4%). We observed differences between the two clinics: discontinuation because of AEs was different (Odds ratio 6.13, 95% CI: 3.0–12.7, p < 0.001), the mean treatment duration also differed (305.3 ± 186.3 vs 140.5 ± 114.4 days, p < 0.001), and dissimilarities in adherence were mainly related to flushing, gastrointestinal AEs, and consideration of lymphopenia (p < 0.0001). Better adherence was associated with prospectively planned management of gastrointestinal AEs and flushing. Conclusion: Adherence in real-life was similar to pivotal trials. Differences in discontinuation rates at two MS clinics underline importance of AE management.

Original languageEnglish
JournalMultiple Sclerosis and Related Disorders
Volume24
Pages (from-to)42-46
ISSN2211-0348
DOIs
Publication statusPublished - 1. Aug 2018

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Lymphopenia
Relapsing-Remitting Multiple Sclerosis
Retrospective Studies
Odds Ratio
Dimethyl Fumarate

Keywords

  • Adherence
  • Dimethyl fumarate
  • Lymphopenia
  • Management
  • Monitoring
  • Multiple sclerosis
  • Tolerability
  • Humans
  • Male
  • Dimethyl Fumarate/adverse effects
  • Multiple Sclerosis, Relapsing-Remitting/drug therapy
  • Patient Acceptance of Health Care
  • Immunosuppressive Agents/adverse effects
  • Adult
  • Female
  • Retrospective Studies

Cite this

@article{d710027bf19e40d3bfa7134e74b85722,
title = "Real-life persistence and tolerability with dimethyl fumarate",
abstract = "Background: Dimethyl fumarate (DMF) has been registered for the treatment of relapsing-remitting multiple sclerosis (RRMS). Differences in tolerability between multiple sclerosis clinics in patients treated with DMF has not been examined. Aim: We examined real-world tolerability to DMF, and also compared adherence data between two MS clinics. Methods: Adverse events (AE), discontinuation rates, and causes of discontinuation were investigated. Results: 253 patients participated in this retrospective study. In the total cohort, 27.7{\%} of the patients discontinued DMF. Higher rate of discontinuation was associated with higher number of previous disease modifying treatments (p < 0.001). Reasons for discontinuation were primarily flushing (15{\%}) and gastrointestinal AEs (51{\%}). Grade III lymphopenia was detected only in 6 cases (2.4{\%}). We observed differences between the two clinics: discontinuation because of AEs was different (Odds ratio 6.13, 95{\%} CI: 3.0–12.7, p < 0.001), the mean treatment duration also differed (305.3 ± 186.3 vs 140.5 ± 114.4 days, p < 0.001), and dissimilarities in adherence were mainly related to flushing, gastrointestinal AEs, and consideration of lymphopenia (p < 0.0001). Better adherence was associated with prospectively planned management of gastrointestinal AEs and flushing. Conclusion: Adherence in real-life was similar to pivotal trials. Differences in discontinuation rates at two MS clinics underline importance of AE management.",
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author = "Tobias Sejbaek and Mads Nybo and Thor Petersen and Zsolt Illes",
note = "Copyright {\circledC} 2018. Published by Elsevier B.V.",
year = "2018",
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Real-life persistence and tolerability with dimethyl fumarate. / Sejbaek, Tobias; Nybo, Mads; Petersen, Thor; Illes, Zsolt.

In: Multiple Sclerosis and Related Disorders, Vol. 24, 01.08.2018, p. 42-46.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Real-life persistence and tolerability with dimethyl fumarate

AU - Sejbaek, Tobias

AU - Nybo, Mads

AU - Petersen, Thor

AU - Illes, Zsolt

N1 - Copyright © 2018. Published by Elsevier B.V.

PY - 2018/8/1

Y1 - 2018/8/1

N2 - Background: Dimethyl fumarate (DMF) has been registered for the treatment of relapsing-remitting multiple sclerosis (RRMS). Differences in tolerability between multiple sclerosis clinics in patients treated with DMF has not been examined. Aim: We examined real-world tolerability to DMF, and also compared adherence data between two MS clinics. Methods: Adverse events (AE), discontinuation rates, and causes of discontinuation were investigated. Results: 253 patients participated in this retrospective study. In the total cohort, 27.7% of the patients discontinued DMF. Higher rate of discontinuation was associated with higher number of previous disease modifying treatments (p < 0.001). Reasons for discontinuation were primarily flushing (15%) and gastrointestinal AEs (51%). Grade III lymphopenia was detected only in 6 cases (2.4%). We observed differences between the two clinics: discontinuation because of AEs was different (Odds ratio 6.13, 95% CI: 3.0–12.7, p < 0.001), the mean treatment duration also differed (305.3 ± 186.3 vs 140.5 ± 114.4 days, p < 0.001), and dissimilarities in adherence were mainly related to flushing, gastrointestinal AEs, and consideration of lymphopenia (p < 0.0001). Better adherence was associated with prospectively planned management of gastrointestinal AEs and flushing. Conclusion: Adherence in real-life was similar to pivotal trials. Differences in discontinuation rates at two MS clinics underline importance of AE management.

AB - Background: Dimethyl fumarate (DMF) has been registered for the treatment of relapsing-remitting multiple sclerosis (RRMS). Differences in tolerability between multiple sclerosis clinics in patients treated with DMF has not been examined. Aim: We examined real-world tolerability to DMF, and also compared adherence data between two MS clinics. Methods: Adverse events (AE), discontinuation rates, and causes of discontinuation were investigated. Results: 253 patients participated in this retrospective study. In the total cohort, 27.7% of the patients discontinued DMF. Higher rate of discontinuation was associated with higher number of previous disease modifying treatments (p < 0.001). Reasons for discontinuation were primarily flushing (15%) and gastrointestinal AEs (51%). Grade III lymphopenia was detected only in 6 cases (2.4%). We observed differences between the two clinics: discontinuation because of AEs was different (Odds ratio 6.13, 95% CI: 3.0–12.7, p < 0.001), the mean treatment duration also differed (305.3 ± 186.3 vs 140.5 ± 114.4 days, p < 0.001), and dissimilarities in adherence were mainly related to flushing, gastrointestinal AEs, and consideration of lymphopenia (p < 0.0001). Better adherence was associated with prospectively planned management of gastrointestinal AEs and flushing. Conclusion: Adherence in real-life was similar to pivotal trials. Differences in discontinuation rates at two MS clinics underline importance of AE management.

KW - Adherence

KW - Dimethyl fumarate

KW - Lymphopenia

KW - Management

KW - Monitoring

KW - Multiple sclerosis

KW - Tolerability

KW - Humans

KW - Male

KW - Dimethyl Fumarate/adverse effects

KW - Multiple Sclerosis, Relapsing-Remitting/drug therapy

KW - Patient Acceptance of Health Care

KW - Immunosuppressive Agents/adverse effects

KW - Adult

KW - Female

KW - Retrospective Studies

U2 - 10.1016/j.msard.2018.05.007

DO - 10.1016/j.msard.2018.05.007

M3 - Journal article

C2 - 29906666

VL - 24

SP - 42

EP - 46

JO - Multiple Sclerosis and Related Disorders

JF - Multiple Sclerosis and Related Disorders

SN - 2211-0348

ER -