Evidence map›Paper›PMID 31172849›Full record

ArticleMultiple sclerosis (Houndmills, Basingstoke, England)2020

Characterizing lymphocyte counts and infection rates with long-term teriflunomide treatment: Pooled analysis of clinical trials.

Giancarlo Comi, Aaron E Miller, Myriam Benamor, Philippe Truffinet, Elizabeth M Poole, Mark S Freedman

Open access · hybridAbstract read
In one paragraph

Article in Multiple sclerosis (Houndmills, Basingstoke, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.5field-weighted citation impact, top 11% 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.

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

10 citing papers in PubMed, 20 citations in OpenAlex.

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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

6 authors at 5 institutions in 4 countries.

Giancarlo ComiVita-Salute San Raffaele University, Milan, Italy.
Aaron E MillerIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Myriam BenamorSanofi, Chilly-Mazarin, France.
Philippe TruffinetSanofi, Chilly-Mazarin, France.
Elizabeth M PooleSanofi, Cambridge, MA, USA.
Mark S FreedmanUniversity of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Sanofi (France) · FRIcahn School of Medicine at Mount Sinai · USOttawa Hospital · CASanofi (United States) · USVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn Phase 3 studies, teriflunomide reduced relapse rates and disability progression compared with placebo; however, decreases in lymphocyte counts were also observed.

objectiveTo describe the effect of long-term teriflunomide treatment on lymphocyte counts and infection rates among patients in pooled analyses of Phase 3 core and extension studies.

methodsFour randomized trials (TEMSO, TOWER, TENERE, and TOPIC) compared teriflunomide 7 mg or 14 mg treatment with either placebo and/or subcutaneous interferon (IFN) β-1a 44 µg in patients with relapsing forms of multiple sclerosis (MS) (or first clinical episode suggestive of MS in TOPIC).

resultsIn 1895, patients ever exposed to teriflunomide, mean (standard deviation) absolute lymphocyte counts declined from Week 0 (1.89 (0.59)) to Week 24 (1.67 (0.52)) and then remained stable thereafter. In the core plus extension studies (up to 10.7 years), 7.3% and 2.2% experienced Grade 1 and Grade 2 lymphopenia, respectively. Infections were reported in 56.9% of patients without lymphopenia, 60.9% with Grade 1 lymphopenia, and 54.8% with Grade 2 lymphopenia. Serious infections occurred in 3.7%, 4.3%, and 7.1%, respectively.

conclusionLong-term risk of lymphopenia and infections in patients who continue to receive teriflunomide is low, demonstrating a limited impact on adaptive and innate immunity.

Indexed as

CrotonatesHydroxybutyratesImmunosuppressive AgentsMultiple Sclerosis, Relapsing-RemittingNitrilesToluidinesFemaleHumansLymphocyte CountCrotonatesHydroxybutyratesImmunosuppressive AgentsNitrilesteriflunomideToluidinesinfection rateslymphocyte countsmultiple sclerosispooled analysisTeriflunomide

Identifiers

PMID31172849
PMCPMC7412877
OpenAlexW2962487873

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Registered trials

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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.