Intestinal Research

Original Articles

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, Takashi Hisabe, Hisatomi Arima, So Imakiire, Eri Yamauchi, Shinya Ashizuka, Fumihito Hirai; Received June 30, 2025 Accepted September 4, 2025 Published online November 27, 2025; DOI: https://doi.org/10.5217/ir.2025.00118 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
The 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.
Methods
Patients 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.
Results
A 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.
Conclusions
The efficacy and safety of IFX-BS after NMS are high. In addition, its trough concentration is serologically non-inferior to baseline values.

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Miscellaneous

Risk factors for severity of colonic diverticular hemorrhage: Ken Kinjo, Toshiyuki Matsui, Takashi Hisabe, Hiroshi Ishihara, Toshiki Kojima, Kenta Chuman, Shigeyoshi Yasukawa, Tsuyoshi Beppu, Akihiro Koga, Satoshi Ishikawa, Masahiro Kishi, Noritaka Takatsu, Fumihito Hirai, Kenshi Yao, Toshiharu Ueki, Masakazu Washio; Intest Res 2018;16(3):458-466. Published online July 27, 2018; DOI: https://doi.org/10.5217/ir.2018.16.3.458

Abstract PDF PubReader ePub

<b>Background/Aims</b><br/>

Colonic diverticular hemorrhage (DH) was a rare disease until the 1990s, and its incidence has increased rapidly since 2000 in Japan. In recent years, colonic DH has been the most frequent cause of lower gastrointestinal bleeding (LGIB). Nearly all cases of DH are mild, with the bleeding often stopping spontaneously. Some cases, however, require surgery or arterial embolization. In this study, using a cohort at Fukuoka University Chikushi Hospital, we investigated factors associated with severe colonic DH.

Methods

Among patients with LGIB who underwent colonoscopy at our hospital between 1995 and 2013, DH was identified in 273 patients. Among them, 62 patients (22.7%) were defined as having severe colonic DH according to recurrence of bleeding in a short period, and/or the necessity of transfusion, arterial embolization, or surgery. We then evaluated risk factors for severe DH among DH patients in this retrospective cohort.

Results

Among the 273 patients with DH, use of non-steroidal anti-inflammatory drugs (NSAIDs) (odds ratio [OR], 2.801; 95% confidence interval [CI], 1.164–6.742), Charlson Risk Index (CRI) ≥2 (OR, 3.336; 95% CI, 1.154–7.353), right-sided colonic DH (OR, 3.873; 95% CI, 1.554–9.653), and symptoms of cerebral hypoperfusion (such as light-headedness, dizziness, or syncope) (OR, 2.926; 95% CI, 1.310–6.535) showed an increased risk of severe DH even after controlling for other factors.

Conclusions

Severe DH occurred in 23% of DH patients, and NSAID use, CRI ≥2, right-sided colonic DH, and symptoms of cerebral hypoperfusion are suggested to be predictors of severe DH.

Citations

Citations to this article as recorded by

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Intestinal Research.2020; 18(1): 121. CrossRef

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