Evidence map›Paper›PMID 40664796›Full record

Observational studyScientific reports2025

Long-term efficacy of therapeutic drug monitoring-guided optimization of ustekinumab maintenance therapy for Crohn's disease patients.

Haixia Ren, Juan Su, Anning Yin, Xinsheng Gao, Wei Wang, Jiao Li, Jian Kang, Jing Wang, Qian Zhou, Jing An and 6 more

Abstract readObservational StudyMulticenter Study
In one paragraph

Observational study in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Haixia RenDepartment of Gastroenterology, Renmin Hospital of Wuhan University, 99 Zhangzhidong Road, Wuhan, 430060, Hubei, China.
Juan SuDepartment of Gastroenterology, Renmin Hospital of Wuhan University, 99 Zhangzhidong Road, Wuhan, 430060, Hubei, China.
Anning YinDepartment of Gastroenterology, Renmin Hospital of Wuhan University, 99 Zhangzhidong Road, Wuhan, 430060, Hubei, China.
Xinsheng GaoDepartment of Pathology, Renmin Hospital of Wuhan University, Wuhan, China.
Wei WangDepartment of Gastroenterology, First Hospital of Yangtze University, Jingzhou, 434000, Hubei, China.
Jiao LiDepartment of Gastroenterology, Renmin Hospital of Wuhan University, 99 Zhangzhidong Road, Wuhan, 430060, Hubei, China.
Jian KangDepartment of Gastroenterology, Renmin Hospital of Wuhan University, 99 Zhangzhidong Road, Wuhan, 430060, Hubei, China.
Jing WangDepartment of Gastroenterology, Renmin Hospital of Wuhan University, 99 Zhangzhidong Road, Wuhan, 430060, Hubei, China.
Qian ZhouDepartment of Gastroenterology, Renmin Hospital of Wuhan University, 99 Zhangzhidong Road, Wuhan, 430060, Hubei, China.
Jing AnDepartment of Gastroenterology, Renmin Hospital of Wuhan University, 99 Zhangzhidong Road, Wuhan, 430060, Hubei, China.
Zhishun TangSports Rehabilitation, College of Sport Medicine, Wuhan Sports University, Wuhan, 430079, Hubei, China.
Xinxin WangSports Rehabilitation, College of Sport Medicine, Wuhan Sports University, Wuhan, 430079, Hubei, China.
Huipeng WanDepartment of Gastroenterology, Renmin Hospital of Wuhan University, 99 Zhangzhidong Road, Wuhan, 430060, Hubei, China.
Wei ChenDepartment of Gastroenterology, Renmin Hospital of Wuhan University, 99 Zhangzhidong Road, Wuhan, 430060, Hubei, China.
Pengbo WuDepartment of Gastroenterology, Renmin Hospital of Wuhan University, 99 Zhangzhidong Road, Wuhan, 430060, Hubei, China.
Ping AnDepartment of Gastroenterology, Renmin Hospital of Wuhan University, 99 Zhangzhidong Road, Wuhan, 430060, Hubei, China. anping_05@163.com.

Funding

Emergency Scientific Research Project of Wuhan Municipal Health Commission EX20B04National Natural Science Foundation of China 81302131National Natural Science Foundation of China 82200598Teaching and Research Project of Wuhan University School of Medicine 2021033
6 · The paper itself

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.

Indexed as

Crohn DiseaseDrug MonitoringUstekinumabAdolescentAdultFemaleHumansMaintenance ChemotherapyMaleRecurrenceRemission InductionRetrospective StudiesTreatment OutcomeYoung AdultUstekinumab

Identifiers

PMID40664796
PMCPMC12264178

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.