Evidence map›Paper›PMID 42344149›Full record

ArticleJournal of human immunity2026

Thalidomide for CGD-related inflammatory bowel disease: A randomized, double-blind trial.

Toshinao Kawai, Mayumi Sako, Katsuhiro Arai, Takashi Ishikawa, Tomoko Toma, Taizo Wada, Yutaro Yada, Masataka Ishimura, Takehiko Doi, Satoshi Okada and 6 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of human immunity, 2026. 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.

Toshinao KawaiDivision of Immunology, National Center for Child Health and Development, Tokyo, Japan.ORCID https://orcid.org/0000-0002-4152-9301
Mayumi SakoDepartment of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.ORCID https://orcid.org/0000-0003-0697-081X
Katsuhiro AraiDivision of Gastroenterology, National Center for Child Health and Development, Tokyo, Japan.ORCID https://orcid.org/0000-0002-6440-4640
Takashi IshikawaDivision of Immunology, National Center for Child Health and Development, Tokyo, Japan.ORCID https://orcid.org/0000-0003-0247-7729
Tomoko TomaDepartment of Pediatrics, School of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan.ORCID https://orcid.org/0009-0001-9307-9023
Taizo WadaDepartment of Pediatrics, School of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan.ORCID https://orcid.org/0000-0002-6146-6379
Yutaro YadaDepartment of Pediatrics, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.ORCID https://orcid.org/0000-0001-7519-7336
Masataka IshimuraDepartment of Pediatrics, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-0735-6566
Takehiko DoiDepartment of Pediatrics, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.ORCID https://orcid.org/0000-0002-6093-0598
Satoshi OkadaDepartment of Pediatrics, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.ORCID https://orcid.org/0000-0002-4622-5657
Hiroshi MoritakeDivision of Pediatrics, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.ORCID https://orcid.org/0000-0001-5471-7646
Kazushi IzawaDepartment of Pediatrics, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID https://orcid.org/0000-0003-1080-0936
Masahiro UekiDepartment of Pediatrics, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.ORCID https://orcid.org/0000-0001-7379-4874
Eisuke InoueShowa Medical University Research Administration Center, Showa Medical University, Tokyo, Japan.ORCID https://orcid.org/0000-0002-1652-7769
Hidefumi NakamuraDepartment of Research and Development Supervision, National Center for Child Health and Development, Tokyo, Japan.ORCID https://orcid.org/0000-0003-0191-2450
Masafumi OnoderaDivision of Immunology, National Center for Child Health and Development, Tokyo, Japan.ORCID https://orcid.org/0000-0001-9449-2066

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Chronic granulomatous disease-related inflammatory bowel disease (CGD-IBD) requires effective and safe therapies, as conventional immunosuppressants increase infection risk. Thalidomide, with anti-inflammatory and immunomodulatory effects, may represent a therapeutic option. This study was conducted to explore the preliminary efficacy and safety of thalidomide for CGD-IBD in a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II trial. Patients were randomized to thalidomide or placebo for a 12-wk blinded phase, followed by a 12-wk extension thalidomide phase. The primary endpoint was achievement of remission or a ≥20-point reduction in the Pediatric Ulcerative Colitis Activity Index. Eight male patients were randomized and analyzed. The primary endpoint was achieved by 1/3 of thalidomide patients versus 0/5 in the placebo group during the blinded phase, and by 5/8 in the extension phase. Secondary endpoints and exploratory endoscopy showed improvements. CGD-related infection rates were comparable before and after treatment. Thalidomide met the prespecified efficacy criterion with an acceptable safety profile in CGD-IBD, suggesting a promising therapeutic option that warrants further clinical studies.

Identifiers

PMID42344149
PMCPMC13289576

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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.