Long-term efficacy of therapeutic drug monitoring-guided optimization of ustekinumab maintenance therapy for Crohn’s disease patients
Abstract Long-term remission in Crohn’s disease (CD) remains challenging. While ustekinumab effectively induces remission, strategies to enhance its maintenance efficacy are urgently needed. This study evaluated therapeutic drug monitoring (TDM)-guided ustekinumab optimization for sustained CD manag...
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Nature Portfolio
2025-07-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-025-09802-5 |
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| author | Haixia Ren Juan Su Anning Yin Xinsheng Gao Wei Wang Jiao Li Jian Kang Jing Wang Qian Zhou Jing An Zhishun Tang Xinxin Wang Huipeng Wan Wei Chen Pengbo Wu Ping An |
| author_facet | Haixia Ren Juan Su Anning Yin Xinsheng Gao Wei Wang Jiao Li Jian Kang Jing Wang Qian Zhou Jing An Zhishun Tang Xinxin Wang Huipeng Wan Wei Chen Pengbo Wu Ping An |
| author_sort | Haixia Ren |
| collection | DOAJ |
| description | Abstract Long-term remission in Crohn’s disease (CD) remains challenging. While ustekinumab effectively induces remission, strategies to enhance its maintenance efficacy are urgently needed. This study evaluated therapeutic drug monitoring (TDM)-guided ustekinumab optimization for sustained CD management. A retrospective observational study was conducted involving 158 patients [TDM: n = 87, age(16 39), male = 64; Non-TDM: n = 71, age(16–40), male = 57] with moderate-to-severe CD who achieved clinical remission following ustekinumab therapy, between October 2020 and November 2024, sourced from three inflammatory bowel disease centers. All patients received 8 weekly ustekinumab maintenance treatment with or without therapeutic drug monitoring (TDM)-guided optimization. The clinical outcomes and disease relapse were evaluated at year 1 and 2. The non-TDM group had a slightly higher endoscopic response and mucosal healing rate at baseline, there were no statistically significant differences between two cohorts at baseline with respect to demographic and clinical characteristics. In this multicenter retrospective study of 158 CD patients in clinical remission, TDM-guided dosing (n = 87) significantly improved 1 year (83.9% vs. 70.4%, p = 0.042) and 2 year remission rates (71.3% vs. 46.5%, p = 0.002) compared to standard therapy (n = 71). Subgroup analyses confirmed benefits in endoscopic responders and mucosal healing cohorts. TDM patients exhibited higher ustekinumab trough levels (3.00 vs. 1.46 μg/mL at year 1, p < 0.001) and lower relapse rates (p = 0.003). Neither the TDM nor the non-TDM cohorts reported any severe adversative events. TDM-guided optimization of ustekinumab maintenance treatment is an efficacious and safe strategy for CD patients with ustekinumab induced clinical remission. |
| format | Article |
| id | doaj-art-c0228f4a5e1f41d5ba1b6147a52f9ce7 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj-art-c0228f4a5e1f41d5ba1b6147a52f9ce72025-08-20T03:45:51ZengNature PortfolioScientific Reports2045-23222025-07-0115111010.1038/s41598-025-09802-5Long-term efficacy of therapeutic drug monitoring-guided optimization of ustekinumab maintenance therapy for Crohn’s disease patientsHaixia Ren0Juan Su1Anning Yin2Xinsheng Gao3Wei Wang4Jiao Li5Jian Kang6Jing Wang7Qian Zhou8Jing An9Zhishun Tang10Xinxin Wang11Huipeng Wan12Wei Chen13Pengbo Wu14Ping An15Department of Gastroenterology, Renmin Hospital of Wuhan UniversityDepartment of Gastroenterology, Renmin Hospital of Wuhan UniversityDepartment of Gastroenterology, Renmin Hospital of Wuhan UniversityDepartment of Pathology, Renmin Hospital of Wuhan UniversityDepartment of Gastroenterology, First Hospital of Yangtze UniversityDepartment of Gastroenterology, Renmin Hospital of Wuhan UniversityDepartment of Gastroenterology, Renmin Hospital of Wuhan UniversityDepartment of Gastroenterology, Renmin Hospital of Wuhan UniversityDepartment of Gastroenterology, Renmin Hospital of Wuhan UniversityDepartment of Gastroenterology, Renmin Hospital of Wuhan UniversitySports Rehabilitation, College of Sport Medicine, Wuhan Sports UniversitySports Rehabilitation, College of Sport Medicine, Wuhan Sports UniversityDepartment of Gastroenterology, Renmin Hospital of Wuhan UniversityDepartment of Gastroenterology, Renmin Hospital of Wuhan UniversityDepartment of Gastroenterology, Renmin Hospital of Wuhan UniversityDepartment of Gastroenterology, Renmin Hospital of Wuhan UniversityAbstract Long-term remission in Crohn’s disease (CD) remains challenging. While ustekinumab effectively induces remission, strategies to enhance its maintenance efficacy are urgently needed. This study evaluated therapeutic drug monitoring (TDM)-guided ustekinumab optimization for sustained CD management. A retrospective observational study was conducted involving 158 patients [TDM: n = 87, age(16 39), male = 64; Non-TDM: n = 71, age(16–40), male = 57] with moderate-to-severe CD who achieved clinical remission following ustekinumab therapy, between October 2020 and November 2024, sourced from three inflammatory bowel disease centers. All patients received 8 weekly ustekinumab maintenance treatment with or without therapeutic drug monitoring (TDM)-guided optimization. The clinical outcomes and disease relapse were evaluated at year 1 and 2. The non-TDM group had a slightly higher endoscopic response and mucosal healing rate at baseline, there were no statistically significant differences between two cohorts at baseline with respect to demographic and clinical characteristics. In this multicenter retrospective study of 158 CD patients in clinical remission, TDM-guided dosing (n = 87) significantly improved 1 year (83.9% vs. 70.4%, p = 0.042) and 2 year remission rates (71.3% vs. 46.5%, p = 0.002) compared to standard therapy (n = 71). Subgroup analyses confirmed benefits in endoscopic responders and mucosal healing cohorts. TDM patients exhibited higher ustekinumab trough levels (3.00 vs. 1.46 μg/mL at year 1, p < 0.001) and lower relapse rates (p = 0.003). Neither the TDM nor the non-TDM cohorts reported any severe adversative events. TDM-guided optimization of ustekinumab maintenance treatment is an efficacious and safe strategy for CD patients with ustekinumab induced clinical remission.https://doi.org/10.1038/s41598-025-09802-5 |
| spellingShingle | Haixia Ren Juan Su Anning Yin Xinsheng Gao Wei Wang Jiao Li Jian Kang Jing Wang Qian Zhou Jing An Zhishun Tang Xinxin Wang Huipeng Wan Wei Chen Pengbo Wu Ping An Long-term efficacy of therapeutic drug monitoring-guided optimization of ustekinumab maintenance therapy for Crohn’s disease patients Scientific Reports |
| title | Long-term efficacy of therapeutic drug monitoring-guided optimization of ustekinumab maintenance therapy for Crohn’s disease patients |
| title_full | Long-term efficacy of therapeutic drug monitoring-guided optimization of ustekinumab maintenance therapy for Crohn’s disease patients |
| title_fullStr | Long-term efficacy of therapeutic drug monitoring-guided optimization of ustekinumab maintenance therapy for Crohn’s disease patients |
| title_full_unstemmed | Long-term efficacy of therapeutic drug monitoring-guided optimization of ustekinumab maintenance therapy for Crohn’s disease patients |
| title_short | Long-term efficacy of therapeutic drug monitoring-guided optimization of ustekinumab maintenance therapy for Crohn’s disease patients |
| title_sort | long term efficacy of therapeutic drug monitoring guided optimization of ustekinumab maintenance therapy for crohn s disease patients |
| url | https://doi.org/10.1038/s41598-025-09802-5 |
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