Ulcerative colitis reporting across medications: FAERS analysis and cross-species transcriptomic triangulation.

Authors

Huan Long, Caihua Duan, Jiusi Liu, Nanxi Xiao, Jiang Huang, Huilei Zeng, Zhenling Gao, Yao Chen

Published in

Frontiers in immunology. Volume 17. Pages 1827266. Epub Oct 09, 2026.

Abstract

Ulcerative colitis (UC) is reported with medications from different therapeutic classes. We examined these reporting associations together with recorded clinical context and tested whether experimental cytokine-blockade signatures align with human UC mucosal expression.
FAERS reports from 2004Q1-2024Q4 were restricted to health professionals and primary-suspect medications. Ten previously identified candidates were evaluated using unique report-generic counts, reporting odds ratios (RORs), proportional reporting ratios, and a supportive Bayesian information component. Sensitivity analysis excluded complete reports recording UC as an indication. Directional signatures from five antibody-versus-isotype contrasts in a 42-sample mouse colitis study were scored in two external human cohorts (87 UC/21 controls and 74 active UC/11 controls), using 12,109 common one-to-one orthologs. Ten primary score comparisons underwent joint Benjamini-Hochberg correction.
Among 7,300,798 eligible FAERS reports, 11,352 included UC. Eight candidates met the specified reporting criteria; seven retained support after UC-indication exclusion. Secukinumab and isotretinoin had 204 and 130 UC reports, with RORs of 4.49 (95% CI 3.90-5.16) and 3.79 (3.19-4.51). Valganciclovir decreased from nine to three reports after exclusion and became imprecise. In human mucosa, experiment-2 IL-17A and IL-17RA blockade signatures scored lower in UC in both cohorts; experiment-1 IL-17RA showed a positive difference in only one cohort. IL-23p19 and IL-12/23p40 blockade signatures scored lower in UC in both cohorts. These patterns persisted across the planned signature-size sensitivity analysis.
Event-centered analysis differentiated reporting associations by their indication context. External experimental and patient data did not support a uniform UC-like transcriptional pattern following IL-17 blockade, refining the mechanistic interpretation of the reporting signals. The findings identify priorities for drug-specific clinical investigation without estimating incidence or establishing causality.

PMID:
42920620
Bibliographic data and abstract were imported from PubMed on 24 Oct 2026.

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