Evidence map›Paper›PMID 27015245›Full record

ArticleTherapeutic drug monitoring2016

Dried Blood Spot Methodology in Combination With Liquid Chromatography/Tandem Mass Spectrometry Facilitates the Monitoring of Teriflunomide.

Aziz Filali-Ansary, Catherine Lunven, Sandrine Turpault, Yann-Joel Beyer, Amy OʼBrien, Astrid Delfolie, Neli Boyanova, Ger-Jan Sanderink, Francesca Baldinetti

Open access · hybridAbstract read
In one paragraph

Article in Therapeutic drug monitoring, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 31% 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

6 citing papers in PubMed, 17 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

9 authors at 2 institutions in 2 countries.

Aziz Filali-Ansary*Sanofi R&D, Alfortville, France; †Sanofi R&D, Chilly-Mazarin, France; ‡Sanofi R&D, Bridgewater, NJ; and §Sanofi Genzyme, Cambridge, MA.
Catherine Lunven
Sandrine Turpault
Yann-Joel Beyer
Amy OʼBrien
Astrid Delfolie
Neli Boyanova
Ger-Jan Sanderink
Francesca Baldinetti
Sanofi (France) · FRSanofi (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTeriflunomide, a once-daily oral immunomodulator approved for treatment of relapsing-remitting multiple sclerosis, is eliminated slowly from plasma. If necessary to rapidly lower plasma concentrations of teriflunomide, an accelerated elimination procedure using cholestyramine or activated charcoal may be used. The current bioanalytical assay for determination of plasma teriflunomide concentration requires laboratory facilities for blood centrifugation and plasma storage. An alternative method, with potential for greater convenience, is dried blood spot (DBS) methodology. Analytical and clinical validations are required to switch from plasma to DBS (finger-prick sampling) methodology.

methodsUsing blood samples from healthy subjects, an LC-MS/MS assay method for quantification of teriflunomide in DBS over a range of 0.01-10 mcg/mL was developed and validated for specificity, selectivity, accuracy, precision, reproducibility, and stability. Results were compared with those from the current plasma assay for determination of plasma teriflunomide concentration.

resultsMethod was specific and selective relative to endogenous compounds, with process efficiency ∼88%, and no matrix effect. Inaccuracy and imprecision for intraday and interday analyses were <15% at all concentrations tested. Quantification of teriflunomide in DBS assay was not affected by blood deposit volume and punch position within spot, and hematocrit level had a limited but acceptable effect on measurement accuracy. Teriflunomide was stable for at least 4 months at room temperature, and for at least 24 hours at 37°C with and without 95% relative humidity, to cover sampling, drying, and shipment conditions in the field. The correlation between DBS and plasma concentrations (R = 0.97), with an average blood to plasma ratio of 0.59, was concentration independent and constant over time.

conclusionsDBS sampling is a simple and practical method for monitoring teriflunomide concentrations.

Indexed as

Blood Specimen CollectionChromatography, LiquidCrotonatesDried Blood Spot TestingDrug StabilityHematocritHumansHydroxybutyratesNitrilesPlasmaReproducibility of ResultsSensitivity and SpecificityTandem Mass SpectrometryToluidinesCrotonatesHydroxybutyratesNitrilesteriflunomideToluidines

Identifiers

PMID27015245
PMCPMC4949010
OpenAlexW2318326814

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.