Uveitis in Patients with Inflammatory Bowel Disease: Pharmacovigilance Signal Detection and Nationwide Claims-Based Evaluation
4 affiliations
- 1Department of Ophthalmology, Hanyang University Guri Hospital, Guri 11923, Republic of Korea
- 2Department of Pre-Medicine, College of Medicine, and Biostatistics Laboratory, Medical Research Collaborating Center, Hanyang University, Seoul 04763, Republic of Korea
- 3College of Pharmacy, Hanyang University, Ansan 15588, Republic of Korea
- 4Department of Ophthalmology, Hanyang University Hospital, Hanyang University College of Medicine, Seoul 04763, Republic of Korea
Abstract
Background/Objectives: To evaluate uveitis risk among biologic users with IBD using signal detection and nationwide outcome data. Methods: We performed a disproportionality analysis of the FDA Adverse Event Reporting System and a retrospective nationwide cohort study of 7862 Korean patients with IBD who initiated adalimumab, vedolizumab, or ustekinumab between 2015 and 2024. Incident uveitis, identified by diagnostic codes, was compared before and after biologic initiation in exploratory analyses to calculate incidence rate ratios, with post-exposure divided into 0–90 and beyond 90 days; cumulative incidence and multivariable Cox regression were also assessed. Post-switch uveitis risk was compared between patients switching from adalimumab to vedolizumab or ustekinumab. Results: Disproportionality analysis identified positive signals for adalimumab (reporting odds ratio, 4.97) and vedolizumab (2.80), but not ustekinumab (0.63). No statistically significant increase in uveitis incidence was observed after biologic initiation in the cohort. No events occurred within 90 days of vedolizumab or ustekinumab initiation; beyond 90 days, incidence rate ratios were 1.3 (95% confidence interval [CI], 0.6–2.9) and 0.6 (95% CI, 0.2–1.7). Adjusted cumulative incidence at the end of follow-up was 1.1%, 0.6%, and 0.2% for adalimumab, vedolizumab, and ustekinumab, with no significant differences on Cox regression. Post-switch risk was similar between vedolizumab and ustekinumab (hazard ratio, 0.88; 95% CI, 0.14–5.58). Conclusions: Pharmacovigilance signals for adalimumab and vedolizumab were not reproduced in a nationwide cohort, in which no statistically significant difference in uveitis risk was detected among the three biologics. Given the small number of events and potential selection bias, these descriptive findings do not exclude clinically important differences between treatments.
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BibTeX
@article{hwang2026uveitis,
title = {{Uveitis in Patients with Inflammatory Bowel Disease: Pharmacovigilance Signal Detection and Nationwide Claims-Based Evaluation}},
author = {Sunjin Hwang and Jiyeong Kim and Eun Hee Hong and Jee-Eun Chung and Seong Joon Ahn},
journal = {Journal of Clinical Medicine},
year = {2026},
month = oct,
doi = {10.3390/jcm15218291},
url = {https://www.mdpi.com/2077-0383/15/21/8291},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Uveitis in Patients with Inflammatory Bowel Disease: Pharmacovigilance Signal Detection and Nationwide Claims-Based Evaluation
AU - Sunjin Hwang
AU - Jiyeong Kim
AU - Eun Hee Hong
AU - Jee-Eun Chung
AU - Seong Joon Ahn
PY - 2026
DA - 2026/10/24
JO - Journal of Clinical Medicine
DO - 10.3390/jcm15218291
UR - https://www.mdpi.com/2077-0383/15/21/8291
AB - Background/Objectives: To evaluate uveitis risk among biologic users with IBD using signal detection and nationwide outcome data. Methods: We performed a disproportionality analysis of the FDA Adverse Event Reporting System and a retrospective nationwide cohort study of 7862 Korean patients with IBD who initiated adalimumab, vedolizumab, or ustekinumab between 2015 and 2024. Incident uveitis, identified by diagnostic codes, was compared before and after biologic initiation in exploratory analyses to calculate incidence rate ratios, with post-exposure divided into 0–90 and beyond 90 days; cumulative incidence and multivariable Cox regression were also assessed. Post-switch uveitis risk was compared between patients switching from adalimumab to vedolizumab or ustekinumab. Results: Disproportionality analysis identified positive signals for adalimumab (reporting odds ratio, 4.97) and vedolizumab (2.80), but not ustekinumab (0.63). No statistically significant increase in uveitis incidence was observed after biologic initiation in the cohort. No events occurred within 90 days of vedolizumab or ustekinumab initiation; beyond 90 days, incidence rate ratios were 1.3 (95% confidence interval [CI], 0.6–2.9) and 0.6 (95% CI, 0.2–1.7). Adjusted cumulative incidence at the end of follow-up was 1.1%, 0.6%, and 0.2% for adalimumab, vedolizumab, and ustekinumab, with no significant differences on Cox regression. Post-switch risk was similar between vedolizumab and ustekinumab (hazard ratio, 0.88; 95% CI, 0.14–5.58). Conclusions: Pharmacovigilance signals for adalimumab and vedolizumab were not reproduced in a nationwide cohort, in which no statistically significant difference in uveitis risk was detected among the three biologics. Given the small number of events and potential selection bias, these descriptive findings do not exclude clinically important differences between treatments.
SN - 2077-0383
ER -