Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies

Amezcua, Lilyana; Mao-Draayer, Yang; Vargas, Wendy; Farber, Rebecca Straus; Schaefer, Sara; Branco, Filipe; England, Sarah M.; Belviso, Nicholas; Lewin, James B.; Mendoza, Jason P.; Shankar, Sai L

doi:10.1007/s40120-023-00475-8

Cited by 3 publications

(1 citation statement)

References 31 publications

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“…Additional information regarding the safety and efficacy of DMF for MS patients comes from several postmarketing real-world studies and retrospective analyses [37][38][39][46][47][48][49][50][51]. One of these studies, PROTEC, investigated the effectiveness of DMF on disease activity and patient-reported outcomes (PROs) in patients with RRMS [46].…”

Section: Mmf Efficacy and Tolerabilitymentioning

confidence: 99%

The Evolving Role of Monomethyl Fumarate Treatment as Pharmacotherapy for Relapsing-Remitting Multiple Sclerosis

Kaye,

Lacey,

et al. 2024

Cureus

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Multiple sclerosis is the most common autoimmune disease affecting the central nervous system (CNS) worldwide. Multiple sclerosis involves inflammatory demyelination of nerve fibers in the CNS, often presenting with recurrent episodes of focal sensory or motor deficits associated with the region of the CNS affected. The prevalence of this disease has increased rapidly over the last decade. Despite the approval of many new pharmaceutical therapies in the past 20 years, there remains a growing need for alternative therapies to manage the course of this disease. Treatments are separated into two main categories: management of acute flare versus long-term prevention of flares via disease-modifying therapy. Primary drug therapies for acute flare include corticosteroids to limit inflammation and symptomatic management, depending on symptoms. Several different drugs have been recently approved for use in modifying the course of the disease, including a group of medications known as fumarates (e.g., dimethyl fumarate, diroximel fumarate, monomethyl fumarate) that have been shown to be efficacious and relatively safe. In the present investigation, we review available evidence focused on monomethyl fumarate, also known as Bafiertam®, along with bioequivalent fumarates for the long-term treatment of relapsing-remitting multiple sclerosis.

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Section: Mmf Efficacy and Tolerabilitymentioning

confidence: 99%

The Evolving Role of Monomethyl Fumarate Treatment as Pharmacotherapy for Relapsing-Remitting Multiple Sclerosis

Kaye,

Lacey,

et al. 2024

Cureus

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NOX2 deficiency enhances priming and activation of the NLRP3 inflammasome

Monjarret,

Shour,

Benyoucef

et al. 2023

Journal of Allergy and Clinical Immunology

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Race and ethnicity in multiple sclerosis phase 3 clinical trials: A systematic review

Ponzano,

Signori,

Bellavia

et al. 2024

Mult Scler

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Background: Distinctive differences in multiple sclerosis (MS) have been observed by race and ethnicity. We aim to (1) assess how often race and ethnicity were reported in clinical trials registered on ClinicalTrials.gov, (2) evaluate whether the population was diverse enough, and (3) compare with publications. Methods: We included phase 3 clinical trials registered with results on ClinicalTrials.gov between 2007 and 2023. When race and/or ethnicity were reported, we searched for the corresponding publications. Results: Out of the 99 included studies, 56% reported race and/or ethnicity, of which only 26% of those primarily completed before 2017. Studies reporting race or ethnicity contributed to a total of 33,891 participants, mainly enrolled in Eastern Europe. Most were White (93%), and the median percentage of White participants was 93% (interquartile range (IQR) = 86%–98%), compared to 3% for Black (IQR = 1%–12%) and 0.2% for Asian (IQR = 0%–1%). Four trials omitted race and ethnicity in publications and even when information was reported, some discrepancies in terminology were identified and categories with fewer participants were often collapsed. Conclusion: More efforts should be done to improve transparency, accuracy, and representativeness, in publications and at a design phase, by addressing social determinants of health that historically limit the enrollment of underrepresented population.

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Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies

Cited by 3 publications

References 31 publications

The Evolving Role of Monomethyl Fumarate Treatment as Pharmacotherapy for Relapsing-Remitting Multiple Sclerosis

The Evolving Role of Monomethyl Fumarate Treatment as Pharmacotherapy for Relapsing-Remitting Multiple Sclerosis

NOX2 deficiency enhances priming and activation of the NLRP3 inflammasome

Race and ethnicity in multiple sclerosis phase 3 clinical trials: A systematic review

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