Abstract
The exposure-response relationship between vedolizumab (VDZ) trough levels (VTLs) and efficacy outcomes has been extensively studied, but data on early VTLs in Asian populations are limited. We assessed clinical outcomes and biochemical response using fecal calprotectin (BioRES[FC]) or C-reactive protein (BioRES[CRP]) at week 14 (W14) and W54, endoscopic healing (EH) at available follow-up time points, and the need for drug optimization during maintenance therapy among 67 patients treated with VDZ (39 Crohn’s disease [CD], and 28 ulcerative colitis [UC]). Associations between early VTLs and outcomes were assessed, with VTL cut-offs proposed using the area under the receiver operating curve (AUC). CD patients achieving W14 BioRES[CRP] had higher VTLs at W6 and W14. W54 BioRES[FC] responders and those not requiring drug optimization had higher W14 VTLs (11.2 vs. 3.8 µg/mL, P = 0.036; 2.2 vs. 5.8 µg/mL, P = 0.004). Proposed W14 VTL cut-offs were 5.3 µg/mL (AUC 0.859) for BioRES[FC] and 4.6 µg/mL (AUC 0.765) for drug optimization. In UC patients, higher early VTLs were noted in those achieving W14 corticosteroid-free clinical remission, W14 BioRES[FC], and W14 EH, but not consistently linked to W54 results. This real-life study suggests higher early VTLs correlated with better outcomes, with W14 VTLs potentially predicting long-term outcomes in CD patients. Future studies are needed to confirm these findings and guide VDZ therapy.
Data availability
The data underlying this article are available from the corresponding author upon reasonable request.
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Acknowledgements
We would like to thank all the patients who provided clinical information for this study. Additionally, we thank Dr. Joon Seo Lim from the Scientific Publications Team at Asan Medical Center for his editorial assistance in preparing this article.
Funding
This work was supported by the National Research Foundation of Korea grant (2021R1A2C2095096), funded by the Ministry of Science and ICT to BDY.
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All authors have made substantial contributions as follows and have approved the final version of the manuscript. KK, ARY, BDY : Conceptualization, KK, ARY, KO, HSH, JYL : Data curation and Investigation, KO, HSH, JYL : Formal analysis, KK, ARY, SWHo, BDY : Writing-original draft, KK, ARY, SWHw, SJM, BDY : Writing-review and editing, SHP, DHY, JSB, SJM : Data interpretation, BDY : Supervision.
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BDY reports consulting fees from AbbVie Korea, BMS Pharmaceutical Korea Ltd., Celltrion, Chong Kun Dang Pharm, CJ Red BIO, Curacle, Daewoong Pharm, Dong-A ST, Ferring Korea, Hanmi Pharmaceutical, Imscout, IQVIA, Johnson & Johnson, Johnson & Johnson Korea, Jeil Pharmaceutical Co., Kangstem Biotech, Korea Otsuka Pharm, Korea United Pharm, Lilly Korea, Medtronic Korea, NanoEntek, ORGANOIDSCIENCES Ltd., Pfizer Korea, Samsung Bioepis, Takeda, Takeda Korea and Yuhan; speaker fees from AbbVie Korea, BMS Pharmaceutical Korea Ltd., Celltrion, Cornerstones Health, Curacle, Daewoong Pharm, Eisai Korea, Ferring Korea, IQVIA, Johnson & Johnson Korea, Pfizer Korea, Samsung Bioepis, and Takeda Korea; and research support from Celltrion and Pfizer Korea. None of these is relevant to this article. The other authors declare no competing interest.
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Kim, K., Yoon, AR., Oh, K. et al. Association of early vedolizumab trough levels with clinical, biochemical, endoscopic response and drug optimization during maintenance therapy in patients with inflammatory bowel diseases. Sci Rep (2026). https://doi.org/10.1038/s41598-026-39413-7
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DOI: https://doi.org/10.1038/s41598-026-39413-7
