Evidence map›Paper›PMID 32472386›Full record

ArticleNeurology and therapy2020

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

Mitzi J Williams, Lilyana Amezcua, Annette Okai, Darin T Okuda, Stanley Cohan, Ray Su, Becky Parks, Jason P Mendoza, James B Lewin, Cynthia C Jones

Abstract 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. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 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.

Mitzi J WilliamsJoi Life Wellness MS Center, Atlanta, GA, USA.
Lilyana AmezcuaKeck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Annette OkaiMultiple Sclerosis Treatment Center of Dallas, Dallas, TX, USA.
Darin T OkudaNeuroinnovation Program, UT Southwestern Medical Center, Dallas, TX, USA.
Stanley CohanProvidence Multiple Sclerosis Center, Providence Brain and Spine Institute, Portland, OR, 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

introductionBlack or African American (black/AA) patients with multiple sclerosis (MS) are reported to exhibit greater disease severity compared with non-black or non-AA patients. Whether differences exist in response to MS disease-modifying therapies remains uncertain, as MS clinical trials have included low numbers of non-white patients. We evaluated real-world safety and effectiveness of dimethyl fumarate (DMF) on MS disease activity in black/AA 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, 4897 non-black/non-AA and 187 black/AA patients were analyzed; median (range) follow-up 18 (2-37) months. Unadjusted annualized relapse rates (ARRs) for 12 months before DMF initiation versus 36 months post DMF initiation, respectively, were: non-black/non-AA patients, 0.83 (95% CI 0.80-0.85) versus 0.10 (95% CI 0.09-0.10), 88% lower ARR (P < 0.0001); black/AA patients, 0.68 (95% CI 0.58-0.80) versus 0.07 (95% CI 0.05-0.10), 90% lower ARR (P < 0.0001). In total, 35 (19%) black/AA patients reported adverse events leading to treatment discontinuation; gastrointestinal disorders were most common (7%), consistent with non-black/non-AA patients (8%). Median lymphocyte counts decreased by 22% in the first year (vs 36% in non-black/non-AA patients), then remained stable and above lower limit of normal in most patients.

conclusionsRelapse rates remained low in black/AA patients, consistent with non-black/non-AA patients. The safety profile of DMF in black/AA patients was consistent with that in the non-black/non-AA ESTEEM population, although lymphocyte decrease was less pronounced in black/AA patients.

Indexed as

Dimethyl fumarateMultiple sclerosisSafety and effectiveness

Identifiers

PMID32472386
PMCPMC7606389

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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.