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.

691 View
99 Download

IBD

Malnutrition and inflammation status in nonobese patients with inflammatory bowel disease are associated with nonalcoholic fatty liver disease: a retrospective study: Takahiro Nagata, Sadahiro Funakoshi, Daisuke Morihara, Satoshi Shakado, Keiji Yokoyama, Kazuhide Takata, Takashi Tanaka, Atsushi Fukunaga, Ryo Yamauchi, Hiromi Fukuda, Hiroki Matsuoka, So Imakiire, Hideto Sakisaka, Satoshi Matsuoka, Nobuaki Kuno, Koichi Abe, Hideki Ishibashi, Shinya Ashizuka, Fumihito Hirai; Intest Res 2023;21(4):471-480. Published online August 11, 2023; DOI: https://doi.org/10.5217/ir.2023.00035

Abstract PDF PubReader ePub

Background/Aims
The frequency and details of nonalcoholic fatty liver disease (NAFLD) complications in patients with inflammatory bowel disease (IBD) remain unclear. This study aimed to clarify characteristics of NAFLD in patients with IBD.
Methods
We retrospectively identified and enrolled patients with IBD diagnosed with or without NAFLD by undergoing abdominal computed tomography (CT) at our institution between 2005 and 2020. The primary endpoint was the complication rate of NAFLD in patients with IBD. Secondary endpoints were the clinical characteristics of nonobese patients with IBD and comorbid NAFLD and their association with nutritional and inflammatory parameters.
Results
Twenty-one (21.9%) of 96 eligible patients with IBD also had NAFLD. In nonobese patients (defined as patients with a body mass index <25 kg/m²), C-reactive protein (CRP; P<0.001) and alanine aminotransferase (P=0.018) levels were higher and the albumin level (P=0.005) and prognostic nutritional index (PNI; P=0.002) values were lower in patients with NAFLD than in those without NAFLD. The PNI value was positively correlated (P<0.001) and the CRP level was negatively correlated (P=0.001) with the hepatosplenic ratio. However, in the NAFLD combined group, PNI (P<0.05) and CRP values (P<0.001) were improved over time after CT imaging by continuing IBD treatment.
Conclusions
Worsening nutritional and inflammatory status in IBD patients is associated with complications of NAFLD. Diagnosis of NAFLD in IBD patients using CT imaging might be useful not only for early detection of NAFLD but also in assessing the need for therapeutic intervention for IBD.

Citations

Citations to this article as recorded by

Elucidating the association between nonalcoholic fatty liver disease and incidence of inflammatory bowel disease: a focus on systemic inflammation
Sihyun Kim, Jong Pil Im
Intestinal Research.2025; 23(1): 3. CrossRef
Metabolic Disorders and Inflammatory Bowel Diseases
Hye Kyung Hyun, Jae Hee Cheon
Gut and Liver.2025; 19(3): 307. CrossRef
Impact of body mass index on clinical outcomes in intestinal Behçet’s disease
Daye Park, Jihye Park, Soo Jung Park, Jae Jun Park, Tae Il Kim, Jae Hee Cheon
The Korean Journal of Internal Medicine.2025; 40(4): 606. CrossRef
Prevalence and Associated Factors of Nonalcoholic Fatty Liver Disease in Patients with Inflammatory Bowel Disease: An Updated Global Systematic Review and Meta-Analysis of over 1.5 Million Individuals
Narsimha Keetha Rao, Shahriar Ghodous, Anoop Gurram, Mehrdad Khorasani, Madhusudhan Ponnala, Arman Habibi, Kwame Agyeman, Parsa Saberian, Pubali Biswas, Negin Letafatkar, Simran Joshi, Yasmin Sahli, Reza Amani-Beni, Bahar Darouei, Yussif Issaka, Kiran San
Inflammatory Bowel Diseases.2025;[Epub] CrossRef

5,602 View
262 Download
4 Web of Science
4 Crossref

First
Prev
Page of 1
Next
Last

Search