ArticleJournal of pharmacokinetics and pharmacodynamics2018
A comprehensive evaluation of exposure-response relationships in clinical trials: application to support guselkumab dose selection for patients with psoriasis.
Article in Journal of pharmacokinetics and pharmacodynamics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 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
11 citing papers in PubMed, 20 citations in OpenAlex.
- Application of Beta-Distribution and Combined Uniform and Binomial Methods in Longitudinal Modeling of Bounded Outcome Score Data.The AAPS journal · 2020Trial
- Mapping the global research landscape of risankizumab: a decade (2016-2025) of multi-database bibliometric analysis and emerging frontiers.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Pharmacokinetic-pharmacodynamic modelling of risankizumab using chronic plaque psoriasis real-world data.British journal of clinical pharmacology · 2026Article
- Model-Informed Precision Dosing for Personalized Ustekinumab Treatment in Plaque Psoriasis.Pharmaceutics · 2024Article
- Impact of using time-averaged exposure metrics on binary endpoints in exposure-response analyses.Frontiers in pharmacology · 2024Article
- Latent variable indirect response modeling of clinical efficacy endpoints with combination therapy: application to guselkumab and golimumab in patients with ulcerative colitis.Journal of pharmacokinetics and pharmacodynamics · 2023Article
- Improving categorical endpoint longitudinal exposure-response modeling through the joint modeling with a related endpoint.Journal of pharmacokinetics and pharmacodynamics · 2022Article
- Impact of Pharmacokinetic and Pharmacodynamic Properties of Monoclonal Antibodies in the Management of Psoriasis.Pharmaceutics · 2022Review
- Population pharmacokinetic/pharmacodynamic analysis of AK111, an IL-17A monoclonal antibody, in subjects with moderate-to-severe plaque psoriasis.Frontiers in pharmacology · 2022Article
- Facilitating Longitudinal Exposure-Response Modeling of a Composite Endpoint Using the Joint Modeling of Sparsely and Frequently Collected Subcomponents.The AAPS journal · 2020Article
- Applying Beta Distribution in Analyzing Bounded Outcome Score Data.The AAPS journal · 2020Article
Corrections and comments
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Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Guselkumab, a human IgG1 monoclonal antibody that blocks interleukin-23, has been evaluated in one Phase 2 and two Phase 3 trials in patients with moderate-to-severe psoriasis, in which disease severity was assessed using Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) scores. Through the application of landmark and longitudinal exposure-response (E-R) modeling analyses, we sought to predict the guselkumab dose-response (D-R) relationship using data from 1459 patients who participated in these trials. A recently developed novel latent-variable Type I Indirect Response joint model was applied to PASI75/90/100 and IGA response thresholds, with placebo effect empirically modeled. An effect of body weight on E-R, independent of pharmacokinetics, was identified. Thorough landmark analyses also were implemented using the same dataset. The E-R models were combined with a population pharmacokinetic model to generate D-R predictions. The relative merits of longitudinal and landmark analysis also are discussed. The results provide a comprehensive and robust evaluation of the D-R relationship.
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Registered trials
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.