Trial reportJournal of pharmacokinetics and pharmacodynamics2026
A Longitudinal Disease Progression Model Characterizing Endoscopic Response and Remission in Crohn's Disease.
Trial report in Journal of pharmacokinetics and pharmacodynamics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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.
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Crohn's disease (CD) is a heterogeneous, progressive inflammatory bowel disease in which substantial placebo effects often confound assessment of therapeutic efficacy. A placebo-based disease model was developed using Simple Endoscopic Score for Crohn's Disease (SES-CD) within an item-level response theory-bounded integer (IRT-BI) and full random effects models (FREM) framework. Longitudinal SES-CD data from 155 placebo-treated patients in the Phase 3 BERGAMOT-trial were analyzed. Each SES-CD subscore, across five intestinal segments, was described by a bounded-integer model and linked through a latent disease variable capturing a mono-exponential placebo trajectory. Endoscopic response (≥50% reduction from baseline SES-CD) and remission (SES-CD 0-2) were defined according to the FDA guidance. IRT-BI model adequately characterized longitudinal trajectories of all SES-CD subscores and accurately predicted individual patient endoscopic response and remission, with predictive accuracy exceeding 89% for responders and 85% for non-responders. Visual predictive checks showed that observed mean trajectories for all 20 SES-CD subscores were within the 90% confidence intervals across the 66-week trial. Population maximum placebo response (R
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