Evidence map›Paper›PMID 32472385›Full record

ArticleNeurology and therapy2020

Real-World Safety and Effectiveness of Dimethyl Fumarate in Hispanic or Latino Patients with Multiple Sclerosis: 3-Year Results from ESTEEM.

Angel Chinea, Lilyana Amezcua, Wendy Vargas, Annette Okai, Mitzi J Williams, Ray Su, Becky Parks, Jason P Mendoza, James B Lewin, Cynthia C Jones

Registry-linked trialAbstract read
In one paragraph

Article in Neurology and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06385197 (Improving the Effect of Dimethyl Fumarate and Diroximel Fumarate), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
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.

NCT06385197 nacompletednot on this mapstarted 2022, after this paper: background citation

Improving the Effect of Dimethyl Fumarate and Diroximel Fumarate (DRF) for Patients With Multiple Sclerosis by Chronobiology

TypeinterventionalSponsorHadassah Medical OrganizationRan2022 to 2023Enrolled8ConditionsMultiple SclerosisArmsApp randomizing dosing regimen
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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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

10 authors.

Angel ChineaFrom the San Juan Multiple Sclerosis Center, Guaynabo, Puerto Rico.
Lilyana AmezcuaKeck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Wendy VargasColumbia University Medical Center, New York, NY, USA.
Annette OkaiMultiple Sclerosis Treatment Center of Dallas, Dallas, TX, USA.
Mitzi J WilliamsJoi Life Wellness MS Center, Atlanta, GA, USA.
Ray SuBiogen, Cambridge, MA, USA.
Becky ParksBiogen, Cambridge, MA, USA.
Jason P MendozaBiogen, Cambridge, MA, USA.
James B LewinBiogen, Cambridge, MA, USA.
Cynthia C JonesBiogen, Cambridge, MA, USA. cynthia.jones@biogen.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCompared with the non-Hispanic/non-Latino population, Hispanic/Latino patients with multiple sclerosis (MS) are reported to exhibit greater disease severity. Geographical location and genetics play a role in differences observed across Hispanic/Latino subpopulations. We evaluated real-world safety and effectiveness of dimethyl fumarate (DMF) on MS disease activity in Hispanic/Latino patients.

methodsESTEEM is an ongoing, 5-year, multinational, prospective study evaluating long-term safety and effectiveness of DMF in patients with MS. This interim analysis included patients newly prescribed DMF in routine practice at 394 sites globally.

resultsOverall, 4986 non-Hispanic/non-Latino and 98 Hispanic/Latino patients were analyzed; median (range) follow-up was 18 (2-37) months. Unadjusted annualized relapse rates (ARRs) for 12 months before DMF initiation versus 36 months post DMF initiation, respectively, were: non-Hispanic/non-Latino patients, 0.82 (95% CI 0.80-0.84) versus 0.10 (95% CI 0.09-0.10), 88% lower ARR (P < 0.0001); Hispanic/Latino patients, 0.80 (95% CI 0.65-1.00) versus 0.09 (95% CI 0.06-0.14), 89% lower ARR (P < 0.0001). In total, 28 (29%) Hispanic/Latino patients reported adverse events leading to treatment discontinuation; gastrointestinal (GI) disorders (n = 10, 10%) were the most common, consistent with the non-Hispanic/non-Latino population (8%). Median lymphocyte counts decreased by approximately 24% in the first year (vs 36% decrease in non-Hispanic/non-Latino patients) then remained stable and above the lower limit of normal in most patients.

conclusionsRelapse rates remained low in Hispanic/Latino patients, consistent with non-Hispanic/non-Latino patients. The safety profile of DMF in Hispanic/Latino patients was consistent with safety findings from the non-Hispanic/non-Latino ESTEEM population, demonstrating the real-world treatment benefit of DMF in the Hispanic/Latino patient cohort.

Indexed as

Dimethyl fumarateMultiple sclerosisSafety and effectiveness

Identifiers

PMID32472385
PMCPMC7606387

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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.