Evidence map›Paper›PMID 41338661›Full record

ArticleIntestinal research2026

Effectiveness, safety, and pharmacokinetics of the infliximab biosimilar CT-P13 after non-medical switch from the infliximab originator in patients with inflammatory bowel disease.

Ryohei Nomaru, Teruyuki Takeda, Atsushi Takahashi, Hiroyuki Mikumo, Shigeyoshi Yasukawa, Akihiro Koga, Takao Kanemitsu, Yoichiro Ono, Noritaka Takatsu, Masaki Miyaoka and 6 more

Abstract read
In one paragraph

Article in Intestinal research, 2026. 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
–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

1 citing paper in PubMed.

  1. 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

16 authors.

Ryohei Nomaru *Department of Gastroenterology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
Teruyuki Takeda *Inflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Atsushi TakahashiInflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Hiroyuki MikumoInflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Shigeyoshi YasukawaInflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Akihiro KogaInflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Takao KanemitsuDepartment of Endoscopy, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Yoichiro OnoDepartment of Gastroenterology, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Noritaka TakatsuInflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Masaki MiyaokaDepartment of Endoscopy, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Takashi HisabeInflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Hisatomi ArimaDepartment of Preventive Medicine and Public Health, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
So ImakiireDepartment of Gastroenterology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
Eri YamauchiDepartment of Gastroenterology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
Shinya AshizukaDepartment of Gastroenterology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
Fumihito HiraiDepartment of Gastroenterology, Fukuoka University Faculty of Medicine, Fukuoka, Japan. fuhirai@cis.fukuoka-u.ac.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsThe introduction of anti-tumor necrosis factor-α antibodies transformed the landscape of inflammatory bowel disease (IBD) treatment. Because biologics are associated with increased medical costs, the use of biosimilars (BS) is recommended. However, high-quality evidence on the efficacy of BS in Japan remains limited. Therefore, this study aimed to evaluate the efficacy and safety of BS in patients with IBD.

methodsPatients with IBD who underwent a non-medical switch (NMS) from infliximab originator (IFX-O) to IFX-BS at Fukuoka University Chikushi Hospital were prospectively evaluated. The observation period was up to 56 weeks after the NMS, and the rate of continuation, clinical remission at 56 weeks, safety, and changes in trough concentration were analyzed. Moreover, a questionnaire survey regarding BS and NMS was conducted.

resultsA total of 167 patients were included in this study. The continuation rate for IFX-BS therapy after NMS was high (95.6%). The remission maintenance rate at 56 weeks was 85.7% for patients with Crohn's disease and 77.8% for patients with ulcerative colitis. Adverse events were observed in 22.8% of patients. However, only 2 severe adverse events were recorded. The ratios of trough concentrations at 8, 24, and 56 weeks to that at week 0 were 115.6%, 101.2%, and 123.5%, respectively, indicating statistical non-inferiority. In a questionnaire survey, only 6.2% of the patients were aware of BS, however, more than half of them agreed with the NMS recommendation.

conclusionsThe efficacy and safety of IFX-BS after NMS are high. In addition, its trough concentration is serologically non-inferior to baseline values.

Indexed as

BiosimilarBio-switchInflammatory bowel diseasesNon-medical switch

Identifiers

PMID41338661
PMCPMC13434528

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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.