Evidence map›Paper›PMID 31194885›Full record

Trial reportClinical pharmacology and therapeutics2019

Exposure-Response Analyses of Upadacitinib Efficacy in Phase II Trials in Rheumatoid Arthritis and Basis for Phase III Dose Selection.

Mohamed-Eslam F Mohamed, Ben Klünder, Heidi S Camp, Ahmed A Othman

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

14 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

4 authors.

Mohamed-Eslam F MohamedClinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, Illinois, USA.
Ben KlünderClinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.
Heidi S CampImmunology Clinical Development, AbbVie, North Chicago, Illinois, USA.
Ahmed A OthmanClinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, Illinois, USA.ORCID 0000-0002-4937-2775

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The relationships between upadacitinib, an oral selective Janus kinase 1 inhibitor, plasma exposures, and its efficacy (assessed by the American College of Rheumatology 20%/50%/70% responses over time) in moderate-to-severe active rheumatoid arthritis (RA) were characterized using data from 574 patients, on background methotrexate and inadequate response to methotrexate or anti-TNF therapy, from two phase II trials conducted with twice-daily dosing of an immediate-release formulation. The developed time-continuous Markov models were used to simulate efficacy of once-daily (q.d.). regimens of upadacitinib extended-release incorporating sources of uncertainty. Upadacitinib plasma concentrations associated with 15 and 30 mg extended-release q.d. doses were predicted to achieve that plateau of response across RA subpopulations. Results from these analyses provided the rationale that supported selection and de-risked evaluation of upadacitinib extended-release doses for the first time in >4,000 patients in five large phase III trials.

Indexed as

AdultAgedAged, 80 and overArthritis, RheumatoidDose-Response Relationship, DrugFemaleHeterocyclic Compounds, 3-RingHumansJanus Kinase InhibitorsMaleMiddle AgedTreatment OutcomeHeterocyclic Compounds, 3-RingJanus Kinase Inhibitorsupadacitinib

Identifiers

PMID31194885
PMCPMC6896251

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.