Separating prognostic association from treatment-effect modification of a baseline mucosal inflammatory-response score in ulcerative colitis biologic trials - 21/10/26
, Qingxi Meng b, Linghan Xue cHighlights |
• | Randomized interaction estimates were directionally consistent but imprecise. |
• | Higher baseline mucosal inflammation was associated with poorer outcome. |
• | Responders showed a greater baseline-adjusted inflammatory-score decline. |
• | Donor-aware single-cell data localized the programme across three compartments. |
• | Prospective independent validation is required before clinical use. |
Abstract |
Background and Aims |
Baseline mucosal inflammation may be associated with outcome without modifying treatment benefit. We separated these questions for a fixed inflammatory-response score in ulcerative colitis biologic studies.
Methods |
A fixed 200-gene score was calculated with platform-specific probe mapping and accession-level baseline standardization. Treatment-by-score interactions were estimated in three randomized active-versus-placebo datasets. Prognostic associations were synthesized across seven treated cohorts, longitudinal change across six paired cohorts, and cellular localization using donor-aware single-cell summaries.
Results |
The randomized branch included 681 participants. All three interaction odds ratios were below one (0.64, 0.46, and 0.76), but their 95% confidence intervals were wide and crossed one. Among 541 actively treated participants, higher baseline scores were associated with poorer outcome (pooled odds ratio 0.44, 0.33-0.58). Among 154 paired participants, responders had a lower baseline-adjusted follow-up score (-1.07 standardized units, -1.61 to -0.53). Analysis of 212,623 cells localized the programme across epithelial, myeloid, and fibroblast/pericyte compartments. Baseline compartment analyses included only 18-19 donors and did not establish a remission association.
Conclusions |
Across the analysed public datasets, baseline mucosal inflammation showed a consistent adverse prognostic association and response-associated decline. The randomized evidence did not establish treatment-effect modification, and prospective independent validation is required before clinical use.
Le texte complet de cet article est disponible en PDF.Keywords : Ulcerative colitis, Biologic therapy, Mucosal transcriptomics, Prognosis, Treatment interaction, Single-cell RNA sequencing
Plan
Vol 50 - N° 9
Article 102943- novembre 2026 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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