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ArticleInflammatory bowel diseases2025

One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn's Disease: The K-STAR Study.

Chang Kyun Lee, Won Moon, Jaeyoung Chun, Eun Soo Kim, Hyung Wook Kim, Hyuk Yoon, Hyun Soo Kim, Yoo Jin Lee, Chang Hwan Choi, Yunho Jung and 8 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Inflammatory bowel diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03942120 (Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03942120 completednot on this map

Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA

TypeobservationalSponsorJanssen Korea, Ltd., KoreaRan2019 to 2022Enrolled685ConditionsCrohn DiseaseArmsUstekinumab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
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

18 authors.

Chang Kyun LeeDepartment of Gastroenterology, Center for Crohn's and Colitis, Kyung Hee University Hospital, Kyung Hee University College of Medicine, Seoul, Korea.
Won MoonDepartment of Internal Medicine, Kosin University College of Medicine, Busan, Korea.
Jaeyoung ChunDepartment of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Eun Soo KimDepartment of Internal Medicine, School of Medicine, Kyungpook National University, Korea.
Hyung Wook KimDepartment of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea.
Hyuk YoonDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Hyun Soo KimDepartment of Internal Medicine, Chonnam University Medical School, Gwangju, Korea.
Yoo Jin LeeDepartment of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
Chang Hwan ChoiDepartment of Internal Medicine, College of Medicine, Chung-Ang University, Seoul, Korea.
Yunho JungDepartment of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.
Sung Chul ParkDepartment of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, Korea.
Geun Am SongDepartment of Internal Medicine, Pusan National University College of Medicine, Busan, Korea.
Jong Hun LeeDepartment of Internal Medicine, Dong-A University Medical Center, Busan, Korea.
Eun Suk JungMedical Affairs, Janssen Korea Ltd., Seoul, Korea.
Youngdoe KimMedical Affairs, Janssen Korea Ltd., Seoul, Korea.
Su Young JungMedical Affairs, Janssen Korea Ltd., Seoul, Korea.
Jong Min ChoiMedical Affairs, Janssen Korea Ltd., Seoul, Korea.
Byong Duk YeDepartment of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.ORCID 0000-0001-6647-6325

Funding

Janssen Korea Ltd
6 · The paper itself

Abstract

backgroundThis study investigated the safety and effectiveness of ustekinumab (UST) in Korean patients with Crohn's disease (CD).

methodsAdult patients with CD treated with UST were prospectively enrolled in the K-STAR (Post-MarKeting Surveillance for Crohn's Disease patients treated with STelARa) study between April 2018 and April 2022. Both the clinical effectiveness and adverse effects of UST therapy were analyzed. Missing data were handled using nonresponder imputation (ClinicalTrials.gov Identifier: NCT03942120).

resultsOf the 464 patients enrolled from 44 hospitals across Korea, 457 and 428 patients (Crohn's disease activity index ≥150) were included in the safety analysis and effectiveness analysis sets, respectively. At weeks 16 to 20 after initiating UST, clinical response, clinical remission, and corticosteroid-free remission rates were 75.0% (321 of 428), 64.0% (274 of 428), and 61.9% (265 of 428), respectively. At week 52 to 66, clinical response, clinical remission, and corticosteroid-free remission rates were 62.4% (267 of 428), 52.6% (225 of 428), and 50.0% (214 of 428), respectively. Combined effectiveness (clinical response + biochemical response) was achieved in 40.0% (171 of 428) and 41.6% (178 of 428) at week 16 to 20 and week 52 to 66, respectively. Biologic-naïve patients exhibited significantly higher rates of combined effectiveness than biologic-experienced patients (50.3% vs 30.7% at week 16-20, P < .001; 47.7% vs 36.0% at week 52-66, P = .014). No additional benefits were observed with the concomitant use of immunomodulators. Ileal location was independently associated with a higher probability of clinical remission compared with colonic or ileocolonic location at week 52 to 66. Adverse and serious adverse events were observed in 28.2% (129 of 457) and 12.7% (58 of 457), respectively, with no new safety signal associated with UST treatment.

conclusionsUstekinumab was well-tolerated, effective, and safe as induction and maintenance therapy for CD in Korea.

Indexed as

Crohn DiseaseUstekinumabAdultFemaleFollow-Up StudiesHumansMaleMiddle AgedProduct Surveillance, PostmarketingProspective StudiesRemission InductionRepublic of KoreaTreatment OutcomeYoung AdultUstekinumabCrohn’s diseaseeffectivenessKoreasafetyustekinumab

Identifiers

PMID39096895
PMCPMC12069984

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Registered trials

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.