Evidence map›Paper›PMID 35459973›Full record

ArticleDigestive diseases and sciences2023

Ustekinumab Is Associated with Real-World Long-Term Effectiveness and Improved Health-Related Quality of Life in Crohn's Disease.

Anders Forss, Mark Clements, Pär Myrelid, Hans Strid, Charlotte Söderman, Agnieszka Wagner, David Andersson, Fredrik Hjelm, PROSE SWIBREG study group, Ola Olén and 2 more

Open access · hybridAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Digestive diseases and sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 5% of its field
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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
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  5. Advances in Crohn's Disease: A Comprehensive Review of Pathophysiology, Diagnosis, and Emerging Therapeutics.JGH open : an open access journal of gastroenterology and hepatology · 2026
    Review
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  18. Can we change the natural course of inflammatory bowel disease?Therapeutic advances in gastroenterology · 2023
    Review
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

12 authors at 7 institutions in 2 countries.

Anders ForssDepartment of Medical Epidemiology and Biostatistics, Karolinska Institutet, Box 281, 171 77, Stockholm, Sweden. anders.forss@ki.se.ORCID 0000-0002-1906-4982
Mark ClementsDepartment of Medical Epidemiology and Biostatistics, Karolinska Institutet, Box 281, 171 77, Stockholm, Sweden.
Pär MyrelidDepartment of Biomedical and Clinical Sciences, Division of Surgery, Linköping University Hospital, Linköping University, Linköping, Sweden.
Hans StridDepartment of Internal Medicine, Södra Älvsborg Hospital, Borås, Sweden.
Charlotte SödermanMedical Department, Capio St Göran Hospital, Stockholm, Sweden.
Agnieszka WagnerDepartment of Internal Medicine, Blekinge Hospital, Karlskrona, Sweden.
David AnderssonDepartment of Internal Medicine, Danderyd University Hospital, Stockholm, Sweden.
Fredrik HjelmJanssen Cilag AB, Solna, Sweden.
PROSE SWIBREG study group
Ola OlénClinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Jonas Halfvarson *Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Jonas F Ludvigsson *Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Box 281, 171 77, Stockholm, Sweden.
Karolinska Institutet · SEÖrebro University · SEDanderyds sjukhus · SELinköping University Hospital · SESaint Göran Hospital · SEScience for Life Laboratory · SESödra Älvsborg Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProspectively and systematically collected long-term real-world clinical data on ustekinumab (anti-interleukin-12/23) are still scarce.

aimsTo assess the long-term effectiveness of ustekinumab in patients with active Crohn's disease (CD).

methodsThis is a prospective multicenter study of adult patients with CD initiating ustekinumab according to recommended doses at 20 Swedish hospitals. The primary outcome was clinical remission (Harvey-Bradshaw Index (HBI) ≤ 4 points) at weeks 52 and 104. Secondary outcomes included clinical response (≥ 3-point-decrease in HBI among patients with initial HBI ≥ 5 points), treatment retention, and biomarkers (C-reactive protein (CRP), hemoglobin, fecal-calprotectin) at weeks 52 and 104 compared to baseline. We also reported Health-related Quality of Life (HRQoL) measures.

resultsOf 114 included patients, 107 (94%) had previously failed ≥ 1 and 58 (51%) ≥ 2 anti-tumor necrosis factor agents. Forty (35%) had failed anti-integrin agents. Ustekinumab retention rates at weeks 52 and 104 were 70% (n = 80/114) and 61% (n = 69/114), respectively. Clinical response was seen in 36% (n = 25/69) and 29% (n = 20/69) of the patients, and remission was achieved in 32% (n = 31/96) and 29% (n = 28/96) at weeks 52 and 104, respectively. Median HBI and CRP levels decreased significantly at both timepoints as compared to baseline. Significant improvements were also observed in HRQoL. Adverse events were reported in 11% (n = 13/114) of the patients, including five cases of severe adverse events. No malignancies were observed.

conclusionsIn this nationwide prospective real-world 104-week-follow-up study of adult patients with active CD, ustekinumab was associated with long-term clinical effectiveness and improvement in HRQoL measures when used in routine clinical care.

Indexed as

Crohn DiseaseUstekinumabAdultFollow-Up StudiesHumansInterleukin-23Prospective StudiesQuality of LifeRemission InductionTreatment OutcomeInterleukin-23UstekinumabCrohn’s diseaseInflammatory bowel diseaseObservational studyUstekinumab

Identifiers

PMID35459973
PMCPMC9883312
OpenAlexW4224281826

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

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.