Evidence map›Paper›PMID 38664814›Full record

ArticleInflammation and regeneration2024

Add-on multiple submucosal injections of the RNA oligonucleotide GUT-1 to anti-TNF antibody treatment in patients with moderate-to-severe ulcerative colitis: an open-label, proof-of concept study.

Kenji Suzuki, Yukinori Sameshima, Junji Yokoyama, Shuji Terai, Hiroyuki Yoneyama, Raja Atreya, Markus F Neurath, Toshifumi Hibi, Hitoshi Asakura

Open access · goldAbstract read
In one paragraph

Article in Inflammation and regeneration, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.1field-weighted citation impact, top 21% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Identification of Ferro-Aging-Related Biomarkers for Ulcerative Colitis Through Integrated Machine Learning, Single-Cell Analysis, and Spatial Transcriptomics.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    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

9 authors at 3 institutions in 2 countries.

Kenji SuzukiDepartment of Gastroenterology, Niigata University Medical and Dental Hospital, 2-746 Asahimach-Dori, Chuo-Ku, Niigata-Shi, Niigata, 951-8518, Japan. kenji-suzuki@nuhw.ac.jp.
Yukinori SameshimaSameshima Hospital, 9-8 Kajiya-Cho, Kagoshima-Shi, Kagoshima, 892-0846, Japan.
Junji YokoyamaDepartment of Gastroenterology, Niigata University Medical and Dental Hospital, 2-746 Asahimach-Dori, Chuo-Ku, Niigata-Shi, Niigata, 951-8518, Japan.
Shuji TeraiDepartment of Gastroenterology, Niigata University Medical and Dental Hospital, 2-746 Asahimach-Dori, Chuo-Ku, Niigata-Shi, Niigata, 951-8518, Japan.
Hiroyuki YoneyamaGUT Inc, 4563-1 Niida, Kochi-Shi, Kochi, 781-0112, Japan.
Raja AtreyaDepartment of Medicine 1, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Ulmenweg 18, 90154, Erlangen, Germany.
Markus F NeurathDepartment of Medicine 1, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Ulmenweg 18, 90154, Erlangen, Germany.
Toshifumi HibiCenter for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, 5-9-1 Shirokane, Minato-Ku, Tokyo, 108-8642, Japan.
Hitoshi AsakuraDepartment of Gastroenterology, Niigata University Medical and Dental Hospital, 2-746 Asahimach-Dori, Chuo-Ku, Niigata-Shi, Niigata, 951-8518, Japan.
Niigata University Medical and Dental Hospital · JPUniversitätsklinikum Erlangen · DEKitasato University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCarbohydrate sulfotransferase 15 (CHST15) is an enzyme biosynthesizing matrix glycosaminoglycan that modulates tissue remodeling. We evaluated the efficacy of add-on submucosal injections of GUT-1, the RNA oligonucleotide inhibitor of CHST15, to ongoing anti-tumor necrosis factor (TNF) antibody treatment in patients with moderate-to-severe ulcerative colitis (UC).

methodsThis was an open-label study of 250 nM of GUT-1 by endoscopic submucosal injections at weeks 0, 2, 4 in five UC patients who lost response during maintenance treatment to anti-TNF antibodies. The primary endpoint was the rate of endoscopic improvement at week 6 and secondary endpoints included the rates of clinical remission by modified Mayo Score (mMS). Patients received follow-up observation with continuous maintenance treatment by the same anti-TNF antibody till the time of clinical recurrence or for overall 52 weeks.

resultsAt week 6, rates of endoscopic improvement and clinical remission were 80% (n = 4/5) and 60% (n = 3/5), respectively. The mean Endoscopy Subscore was reduced from 2.4 (95%CI: 1.7 to 3.1) at baseline, to 1.0 (95%CI: 0.1 to 1.9) at week 6. The mean mMS was reduced from 7.8 (95%CI: 6.2 to 9.4) to 1.3 (95%CI: 2.9 to 4.3). GUT-1 was well tolerated. Three patients did not show clinical recurrence for 52 weeks. All three corticosteroid-dependent patients showed no corticosteroid exposure for at least 24 weeks after achieving clinical remission. Multiple dosing was also well tolerated.

conclusionsAdd-on multiple injections of GUT-1 to ongoing anti-TNF antibody was able to induce rapid and durable clinical responses in UC patients who lost response to anti-TNF therapy.

trial registrationClinical trial Registration Number (Japan): UMIN000020900.

Indexed as

CHST15Clinical remissionEndoscopic improvementTNF antibodyUlcerative colitis

Identifiers

PMID38664814
PMCPMC11044299
OpenAlexW4395457741

What OpenQuestion holds

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LicenceCC BY
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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.