Evidence map›Paper›PMID 25038623›Full record

ArticleJournal of pharmacokinetics and pharmacodynamics2014

Latent variable indirect response joint modeling of a continuous and a categorical clinical endpoint.

Chuanpu Hu, Philippe O Szapary, Alan M Mendelsohn, Honghui Zhou

Abstract read
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In one paragraph

Article in Journal of pharmacokinetics and pharmacodynamics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 citing papers in PubMed.

  1. Trial
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  12. Modeling Composite Assessment Data Using Item Response Theory.CPT: pharmacometrics & systems pharmacology · 2018
    Article
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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.

Chuanpu HuPharmacokinetics and Pharmacometrics, Biologics Clinical Pharmacology, Janssen Research and Development, LLC, 1400 McKean Road, PO Box 776, Spring House, PA, 19477, USA, CHu25@its.jnj.com.
Philippe O Szapary
Alan M Mendelsohn
Honghui Zhou

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Informative exposure-response modeling of clinical endpoints is important in drug development. There has been much recent progress in latent variable modeling of ordered categorical endpoints, including the application of indirect response (IDR) models and accounting for residual correlations between multiple categorical endpoints. This manuscript describes a framework of latent-variable-based IDR models that facilitate easy simultaneous modeling of a continuous and a categorical clinical endpoint. The model was applied to data from two phase III clinical trials of subcutaneously administered ustekinumab for the treatment of psoriatic arthritis, where Psoriasis Area and Severity Index scores and 20, 50, and 70 % improvement in the American College of Rheumatology response criteria were used as efficacy endpoints. Visual predictive check and external validation showed reasonable parameter estimation precision and model performance.

Indexed as

Antibodies, Monoclonal, HumanizedArthritis, PsoriaticArthritis, RheumatoidClinical Trials, Phase III as TopicEndpoint DeterminationHumansInjections, SubcutaneousMethotrexateModels, StatisticalMulticenter Studies as TopicPsoriasisRandomized Controlled Trials as TopicReproducibility of ResultsUstekinumabAntibodies, Monoclonal, HumanizedMethotrexateUstekinumab

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.