Evidence map›Paper›PMID 37354276›Full record

ArticleNeurology and therapy2023

Real-World Safety and Effectiveness After 5 Years of Dimethyl Fumarate Treatment in Black and Hispanic Patients with Multiple Sclerosis in ESTEEM.

Mitzi J Williams, Lilyana Amezcua, Angel Chinea, Stanley Cohan, Annette Okai, Darin T Okuda, Wendy Vargas, Nick Belviso, Ivan Božin, Xiaotong Jiang and 5 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02047097 (A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.0field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02047097 completednot on this map

A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM)

Typeobservational_patient_registrySponsorBiogenRan2013 to 2022Enrolled5,487ConditionsMultiple SclerosisArmsdimethyl fumarate
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 6 institutions in 1 country.

Mitzi J WilliamsJoi Life Wellness MS Center, Atlanta, GA, USA.
Lilyana AmezcuaKeck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Angel ChineaSan Juan MS Center, Guaynabo, Puerto Rico.
Stanley CohanProvidence Portland Medical Center, Portland, OR, USA.
Annette OkaiNorth Texas Institute of Neurology and Headache, Plano, TX, USA.
Darin T OkudaNeuroinnovation Program, UT Southwestern Medical Center, Dallas, TX, USA.
Wendy VargasColumbia University Medical Center, New York City, NY, USA.
Nick BelvisoBiogen, Cambridge, MA, USA.
Ivan BožinBiogen, Cambridge, MA, USA.
Xiaotong JiangBiogen, Cambridge, MA, USA.ORCID http://orcid.org/0000-0003-3698-4526
James B LewinBiogen, Cambridge, MA, USA.
Jennifer LyonsBiogen, Cambridge, MA, USA.
Changyu ShenBiogen, Cambridge, MA, USA.
Sarah M EnglandBiogen, Cambridge, MA, USA. sarah.england@biogen.com.ORCID http://orcid.org/0009-0008-0232-278X
Nydjie GrimesBiogen, Cambridge, MA, USA.
Biogen (United States) · USColumbia University Irving Medical Center · USProvidence Portland Medical Center · USSouthwestern Medical CenterTexas Neurology · USUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMultiple sclerosis (MS) clinical trials have included low numbers of patients from racial and ethnic minority populations; therefore, it is uncertain whether differences exist in response to disease-modifying therapies. We evaluated the real-world safety and effectiveness of dimethyl fumarate (DMF) treatment over 5 years in four patient cohorts: Black, non-Black, Hispanic, and non-Hispanic people with relapsing-remitting MS.

methodsESTEEM is an ongoing, 5-year, multinational, prospective study evaluating the long-term safety and effectiveness of DMF in people with MS. The analysis included patients newly prescribed DMF in routine practice at 393 sites globally.

resultsOverall, 5251 patients were analyzed (220 Black, 5031 non-Black; 105 Hispanic, 5146 non-Hispanic). Median (min-max) months of follow-up was 32 (0-72) for Black, 29 (1-77) for Hispanic, and 41 (0-85) for both the non-Black and non-Hispanic populations. In total, 39 (18%) Black and 29 (28%) Hispanic patients reported adverse events leading to treatment discontinuation versus 1126 (22%) non-Black and 1136 (22%) non-Hispanic patients; gastrointestinal disorders were the most common in all subgroups. Median lymphocyte counts decreased by 37% in Black, 40% in non-Black, 10% in Hispanic, and 39% in non-Hispanic patients in the first year, then remained stable and above the lower limit of normal in most patients. Annualized relapse rates (ARRs) (95% confidence intervals) up to 5 years were 0.054 (0.038-0.078) for Black, 0.077 (0.072-0.081) for non-Black, 0.069 (0.043-0.112) for Hispanic, and 0.076 (0.072-0.081) for non-Hispanic populations, representing reductions of 91-92% compared with ARR 12 months before study entry (all p < 0.0001).

conclusionThe safety profile of DMF in these subgroups was consistent with the overall ESTEEM population. Relapse rates remained low in Black and Hispanic patients, and consistent with non-Black and non-Hispanic patients. These data demonstrate a comparable real-world treatment benefit of DMF in Black and Hispanic patients.

trial registrationClinicalTrials.gov identifier NCT02047097.

Indexed as

Dimethyl fumarateMinority populationsMultiple sclerosisSafety and effectiveness

Identifiers

PMID37354276
PMCPMC10444730
OpenAlexW4381855659

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.