Trial reportJournal of pharmacokinetics and pharmacodynamics2011
Bounded outcome score modeling: application to treating psoriasis with ustekinumab.
Trial report in Journal of pharmacokinetics and pharmacodynamics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
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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.
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.
Who cites it
19 citing papers in PubMed, 33 citations in OpenAlex.
- Employing zero-inflated beta distribution in an exposure-response analysis of TYK2/JAK1 inhibitor brepocitinib in patients with plaque psoriasis.Journal of pharmacokinetics and pharmacodynamics · 2024Trial
- Baseline-adjusted proportional odds models for the quantification of treatment effects in trials with ordinal sum score outcomes.BMC medical research methodology · 2020Trial
- Joint longitudinal model development: application to exposure-response modeling of ACR and DAS scores in rheumatoid arthritis patients treated with sirukumab.Journal of pharmacokinetics and pharmacodynamics · 2018Trial
- Improvement in latent variable indirect response modeling of multiple categorical clinical endpoints: application to modeling of guselkumab treatment effects in psoriatic patients.Journal of pharmacokinetics and pharmacodynamics · 2017Trial
- Information contributed by meta-analysis in exposure-response modeling: application to phase 2 dose selection of guselkumab in patients with moderate-to-severe psoriasis.Journal of pharmacokinetics and pharmacodynamics · 2014Trial
- Latent variable indirect response modeling of categorical endpoints representing change from baseline.Journal of pharmacokinetics and pharmacodynamics · 2013Trial
- Comparison of the power and type 1 error of total score models for drug effect detection in clinical trials.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- Role of Disease Progression Models in Drug Development.Pharmaceutical research · 2022Review
- Bounded Integer Modeling of Symptom Scales Specific to Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.The AAPS journal · 2021Article
- On the Comparison of Methods in Analyzing Bounded Outcome Score Data.The AAPS journal · 2019Review
- A Bounded Integer Model for Rating and Composite Scale Data.The AAPS journal · 2019Article
- Modeling near-continuous clinical endpoint as categorical: application to longitudinal exposure-response modeling of Mayo scores for golimumab in patients with ulcerative colitis.Journal of pharmacokinetics and pharmacodynamics · 2018Article
- A comprehensive evaluation of exposure-response relationships in clinical trials: application to support guselkumab dose selection for patients with psoriasis.Journal of pharmacokinetics and pharmacodynamics · 2018Article
- Improvement in latent variable indirect response joint modeling of a continuous and a categorical clinical endpoint in rheumatoid arthritis.Journal of pharmacokinetics and pharmacodynamics · 2016Article
- Modeling of bounded outcome scores with data on the boundaries: application to disability assessment for dementia scores in Alzheimer's disease.The AAPS journal · 2014Article
- Latent variable indirect response joint modeling of a continuous and a categorical clinical endpoint.Journal of pharmacokinetics and pharmacodynamics · 2014Article
- Exposure-response modeling of clinical end points using latent variable indirect response models.CPT: pharmacometrics & systems pharmacology · 2014Article
- Mixed-effects beta regression for modeling continuous bounded outcome scores using NONMEM when data are not on the boundaries.Journal of pharmacokinetics and pharmacodynamics · 2013Article
- Development of a placebo effect model combined with a dropout model for bipolar disorder.Journal of pharmacokinetics and pharmacodynamics · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Disease status is often measured with bounded outcome scores (BOS) which report a discrete set of values on a finite range. The distribution of BOS data is often non-standard, e.g., J- or U-shaped, thus making standard analysis methods that assume normality inappropriate. Data transformations aiming to achieve normality with BOS can be much more difficult than with many other types of skewed distributions, and application of methodologies explicitly dealing with this problem has not been previously published in pharmacokinetic/pharmacodynamic modeling literature. In this analysis, a coarsened latent variable (CO) approach is augmented with flexible transformations and applied for the purpose of demonstrating ustekinumab effects on four clinical components (involved body surface area, induration, erythema, and scaling) in patients with moderate to severe psoriasis from two Phase 3 studies. Patients were randomized to receive placebo or ustekinumab 45 or 90 mg, followed by randomized withdrawal and long-term extension periods. The approach was used together with a previously established novel semi-mechanistic, mixed-effect exposure-response model integrated with placebo effect and disease progression, and with potential influence of dropout investigated. An additional transformation further modifying both tails of the standard logit transformation in the original CO approach was shown to be necessary in this application.
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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.