Dimethyl fumarate transfer into human milk

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Abstract

Dimethyl fumarate (DMF) is approved for the treatment of relapsing-remitting multiple sclerosis. It is unknown whether DMF or its primary metabolite monomethyl fumarate (MMF) are excreted into human milk. We present two cases of lactating patients who donated milk samples to study the transfer of MMF into human milk following a week of 2 × 240 mg daily oral dose. Samples were analyzed using liquid chromatography mass spectrometry. The calculated relative infant dose was 0.019% and 0.007%. This is the first study to demonstrate that MMF is transferred into human milk, with only limited exposure to an infant.

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Most cited references 9

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Insight into the mechanism of action of dimethyl fumarate in multiple sclerosis

Sudhir Yadav, Devika Soin, Kouichi Ito … (2019)

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Treatment of severe psoriasis with fumaric acid esters: scientific background and guidelines for therapeutic use. The German Fumaric Acid Ester Consensus Conference.

P Altmeyer, E Christophers, U. Mrowietz (1999)

Fumaric acid ester (FAE) therapy has proved to be safe and effective in patients with severe psoriasis vulgaris. This treatment was introduced nearly 30 years ago, but is only now gaining renewed interest among dermatologists. FAE therapy is licensed in Germany and registration is pending in many European countries. Multicentre trials have confirmed the beneficial effect of FAE in psoriasis and have defined the spectrum of its adverse effects. Although the mode of action of FAEs in the treatment of psoriasis is not fully understood, recent experimental data point towards a skewing of the Th1-dominated T-cell response in psoriasis to a Th2-like pattern, and inhibition of proliferation of keratinocytes. This article reviews the experimental and clinical information on FAEs in psoriasis and provides guidelines for the clinical use of FAEs derived from a consensus meeting of leading experts.

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Dimethyl fumarate: a review of its use in patients with relapsing-remitting multiple sclerosis.

Emma D Deeks, C E Burness (2014)

Dimethyl fumarate (Tecfidera®) is a novel oral therapy that has recently been approved for the treatment of relapsing forms of multiple sclerosis (MS) and relapsing-remitting MS (RRMS). In preclinical studies, dimethyl fumarate exhibited anti-inflammatory and cytoprotective properties that are generally thought to be mediated via activation of the nuclear factor (erythroid-derived 2)-like 2 transcriptional pathway, which is involved in the cellular response to oxidative stress. In the large, double-blind, multinational, 2-year DEFINE and CONFIRM trials conducted in over 2,600 adult patients with RRMS, twice-daily oral dimethyl fumarate 240 mg was effective in reducing the proportion of patients with MS relapse at 2 years (primary endpoint of DEFINE) and the annualized relapse rate (primary endpoint of CONFIRM) compared with placebo, with reduced disability progression also observed with the drug versus placebo in DEFINE. Dimethyl fumarate also reduced disease activity measures relative to placebo in these trials, as assessed by magnetic resonance imaging. Dimethyl fumarate was generally well tolerated in patients with RRMS; adverse events that occurred more frequently in dimethyl fumarate than in placebo recipients included flushing and gastrointestinal events. The long-term efficacy and tolerability of dimethyl fumarate is currently being investigated in the ENDORSE trial, with interim results demonstrating that dimethyl fumarate was associated with continued efficacy for up to 4 years of treatment, with no new tolerability concerns. In conclusion, although more comparative data are needed to fully establish the relative efficacy and tolerability of dimethyl fumarate compared with other therapies, oral dimethyl fumarate is an important addition to the therapeutic options available for RRMS.

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Author and article information

Contributors

Andrea I. Ciplea

Palika Datta

Kathleen Rewers-Felkins

Teresa Baker

Ralf Gold

Thomas W. Hale

Kerstin Hellwig:

ORCID: https://orcid.org/0000-0003-4467-9011

Journal

Journal ID (nlm-ta): Ther Adv Neurol Disord

Journal ID (iso-abbrev): Ther Adv Neurol Disord

Journal ID (publisher-id): TAN

Journal ID (hwp): sptan

Title: Therapeutic Advances in Neurological Disorders

Publisher: SAGE Publications (Sage UK: London, England )

ISSN (Print): 1756-2856

ISSN (Electronic): 1756-2864

Publication date (Electronic): 31 October 2020

Publication date Collection: 2020

Volume: 13

Electronic Location Identifier: 1756286420968414

Affiliations

[1-1756286420968414]Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Germany

[2-1756286420968414]Department of Pediatrics, Texas Tech University Health Sciences Center, Amarillo, TX, USA

[3-1756286420968414]Department of Pediatrics, Texas Tech University Health Sciences Center, Amarillo, TX, USA

[4-1756286420968414]Department of Obstetrics and Gynecology, Texas Tech University Health Sciences Center, Amarillo, TX, USA

[5-1756286420968414]Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Germany

[6-1756286420968414]Department of Pediatrics, Texas Tech University Health Sciences Center, Amarillo, TX, USA

[7-1756286420968414]Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Gudrunstrasse 56, Bochum, 44791, Germany

Author notes

[*] k.hellwig@ 123456klinikum-bochum.de

[*]

Shared senior authorship.

Author information

Kerstin Hellwig https://orcid.org/0000-0003-4467-9011

Article

Publisher ID: 10.1177_1756286420968414

DOI: 10.1177/1756286420968414

PMC ID: 7607748

PubMed ID: 33193814

SO-VID: 1989e77b-9d73-4946-aa5a-44373007155b

License:

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

History

Date received : 6 August 2020

Date accepted : 28 September 2020

Custom metadata

cover-date January-December 2020

typesetter ts1

Keywords: multiple sclerosis,tecfidera,dimethyl fumarate,lactation,human milk

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Keywords: multiple sclerosis, tecfidera, dimethyl fumarate, lactation, human milk

Dimethyl fumarate transfer into human milk

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Karger: Neurology and Neuroscience

Most cited references 9

Insight into the mechanism of action of dimethyl fumarate in multiple sclerosis

Treatment of severe psoriasis with fumaric acid esters: scientific background and guidelines for therapeutic use. The German Fumaric Acid Ester Consensus Conference.

Dimethyl fumarate: a review of its use in patients with relapsing-remitting multiple sclerosis.

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