Evidence map›Paper›PMID 35072287›Full record

Trial reportBritish journal of clinical pharmacology2022

Exposure-response relationships for the efficacy and safety of filgotinib and its metabolite GS-829845 in subjects with rheumatoid arthritis based on phase 2 and phase 3 studies.

Amy Meng, Kacey Anderson, Cara Nelson, Liyun Ni, Shu-Min Chuang, Francesco Bellanti, Peter Chang, Craig Comisar, Brian P Kearney, Beatrix Bartok and 1 more

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 22% 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, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
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  3. Trial
  4. Trial
  5. Review
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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

11 authors at 2 institutions in 1 country.

Amy MengGilead Sciences Inc, Foster City, CA, USA.ORCID 0000-0003-2583-2455
Kacey AndersonGilead Sciences Inc, Foster City, CA, USA.
Cara NelsonGilead Sciences Inc, Foster City, CA, USA.
Liyun NiGilead Sciences Inc, Foster City, CA, USA.
Shu-Min ChuangGilead Sciences Inc, Foster City, CA, USA.
Francesco BellantiCertara Inc, Princeton, NJ, USA.
Peter ChangCertara Inc, Princeton, NJ, USA.
Craig ComisarCertara Inc, Princeton, NJ, USA.
Brian P KearneyGilead Sciences Inc, Foster City, CA, USA.
Beatrix BartokGilead Sciences Inc, Foster City, CA, USA.
Anita MathiasGilead Sciences Inc, Foster City, CA, USA.
Gilead Sciences (United States) · USPrinceton University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsFilgotinib is a potent, oral, JAK1-preferential inhibitor for the treatment of rheumatoid arthritis (RA). This report describes exposure-response (ER) analyses of filgotinib for dose confirmation based on three phase 3 and two phase 2 studies in moderate to severe RA patients.

methodsThe pharmacokinetic exposures used in ER analyses were derived from population pharmacokinetic analysis. The exposure-efficacy relationships were assessed for efficacy endpoints (ACR20/50/70 and DAS28) over effective area under curve (AUC

resultsThe nonlinear logistic regression showed increasing response with increasing exposure, with exposures at 200 mg dose primarily residing on the curve plateau. Also, AUC

conclusionsER analyses confirmed that filgotinib produced more robust therapeutic effects across the exposure range observed at 200 mg once daily compared to lower doses, and collectively with the lack of exposure-safety relationship, the 200 mg once daily dose was supported for commercialization.

Indexed as

Arthritis, RheumatoidPyridinesTriazolesAntirheumatic AgentsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicHumansJanus Kinase InhibitorsTreatment OutcomeAntirheumatic AgentsGLPG0634Janus Kinase InhibitorsPyridinesTriazolesdrug safetyPK-PDrandomized controlled trialrheumatoid arthritisSpecialties: filgotinib, JAK inhibitors, exposure-responsetherapeutics

Identifiers

PMID35072287
PMCPMC9305466
OpenAlexW4207058417

What OpenQuestion holds

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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.