Intestinal Research

Case Report

Inflammatory bowel disease in a young female patient with a novel de novo TRAF3 frameshift variant responsive to ustekinumab: a case report: Ichiro Takeuchi, Kosuke Taniguchi, Katsuhiro Arai, Toru Uchiyama, Miho Terao, Asuka Hori, Toshinao Kawai, Takako Yoshioka, Reiko Kyodo, Hirotaka Shimizu, Satoshi Fujita, Kenichiro Motomura, Yuka Okazaki, Takashi Ishikawa, Masao Ogura, Kentaro Hayashi, Kenji Matsumoto, Shuji Takada, Masafumi Onodera, Hideaki Morita, Kenichiro Hata; Received November 15, 2024 Accepted March 4, 2025 Published online April 4, 2025; DOI: https://doi.org/10.5217/ir.2024.00190 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Tumor necrosis factor receptor-associated factor 3 (TRAF3) is an anti-inflammatory molecule that negatively regulates the non-canonical nuclear factor-κB pathway. Although TRAF3 haploinsufficiency (TRAF3 HI) can influence innate and adaptive immune cells, its effect on inflammatory bowel disease (IBD) development remains unclear. Here, we report the first case of severe early-onset IBD with a novel TRAF3 variant leading to HI, successfully treated with ustekinumab. A 6-year-old girl with a recurrent parotitis, otitis media, tonsilitis, and atopic dermatitis developed IBD involving the stomach, small intestine, and colon. At diagnosis, the immunoglobulin (Ig)G and IgA levels were relatively high, and lymphocyte subsets showed increased counts of plasmablasts, class-switch recombination B cells, and circulating T-follicular helper cells. Treatment with azathioprine and infliximab failed to maintain remission marked by several relapses accompanied by erythema nodosum and arthritis; however, ustekinumab, an anti-interleukin (IL)-12/23p40 antibody, led to long-term clinical remission, normalizing the Ig level and reducing abnormal lymphocyte counts. Whole-exome sequencing revealed a novel heterozygous mutation in TRAF3 [p.(Pro487Leufs*8)], resulting in TRAF3 under-expression. Our case may highlight the contribution of TRAF3 HI to the development of IBD and provide insights into IBD pathophysiology, suggesting the involvement of the IL-12/23-T-follicular helper cell pathway affected by genetic mutations.

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Original Articles

Persistence of advanced therapies in patients with inflammatory bowel disease: retrospective cohort study using a large healthcare claims database in Japan: Katsuyoshi Matsuoka, Ko Nakajo, Shiho Kawamura, Yongjing Zhang, Hsingwen Chung, Bryan Wahking, Jin Yu Tan, Hong Qiu; Received July 22, 2024 Accepted October 8, 2024 Published online January 2, 2025; DOI: https://doi.org/10.5217/ir.2024.00118 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
There are few studies that comprehensively report real-world persistence for first-line advanced therapies used to treat inflammatory bowel disease. We aimed to describe persistence of first-line advanced therapies among incident biologic or Janus kinase inhibitor users with inflammatory bowel disease.
Methods
Retrospective cohort study using the Japan Medical Data Center database from January 1, 2010, until September 30, 2022. Patients aged ≥15 years with relevant diagnostic and treatment codes were included. All eligible patients were observed until study end (September 30, 2022), death, or disenrollment, whichever occurred first.
Results
Among 1,115 patients with Crohn’s disease included in the analysis, 41.4% initiated adalimumab, 37.4% infliximab, 18.1% ustekinumab, and 3.0% vedolizumab. Median age was 31.2–34.8 years, 72.8% to 85.9% were male. Persistence at 12 months was 84.7% for adalimumab, 87.7% for infliximab, 91.3% for ustekinumab, and 53.1% for vedolizumab. Persistence at 24 months was 76.3%, 76.8%, 80.4%, and 28.6%, respectively. Among 1,942 patients with ulcerative colitis, 24.8% initiated adalimumab, 33.6% infliximab, 11.2% golimumab, 17.5% vedolizumab, 5.6% ustekinumab, and 7.3% tofacitinib. Mean age was 38.2–40.4 years, 57.4% to 65.8% were male. Persistence at 12 months was 57.6% for adalimumab, 87.7% for infliximab, 54.9% for golimumab, 69.7% for vedolizumab, and 84.0% for ustekinumab. At month 24, persistence for ustekinumab was 75.0%, versus 42.9%–59.4% for other treatments.
Conclusions
Index treatment with ustekinumab resulted in high persistence through 24 months after initiation in patients with Crohn’s disease or ulcerative colitis. Our study provides insights into the real-world usage of advanced treatments for patients with IBD in Japan.

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IBD

Real-world effectiveness and safety of ustekinumab induction therapy for Korean patients with Crohn’s disease: a KASID prospective multicenter study: Kyunghwan Oh, Hee Seung Hong, Nam Seok Ham, Jungbok Lee, Sang Hyoung Park, Suk-Kyun Yang, Hyuk Yoon, You Sun Kim, Chang Hwan Choi, Byong Duk Ye, on behalf of the Korean Association for the Study of Intestinal Diseases; Intest Res 2023;21(1):137-147. Published online July 12, 2022; DOI: https://doi.org/10.5217/ir.2021.00173; Correction in: Intest Res 2023;21(2):273

Abstract PDF PubReader ePub

Background/Aims
We investigated the real-world effectiveness and safety of ustekinumab (UST) as induction treatment for Koreans with Crohn’s disease (CD).
Methods
CD patients who started UST were prospectively enrolled from 4 hospitals in Korea. All enrolled patients received intravenous UST infusion at week 0 and subcutaneous UST injection at week 8. Clinical outcomes were assessed using Crohn’s Disease Activity Index (CDAI) scores at weeks 8 and 20 among patients with active disease (CDAI ≥150) at baseline. Clinical remission was defined as a CDAI <150, and clinical response was defined as a reduction in CDAI ≥70 points from baseline. Safety and factors associated with clinical remission at week 20 were also analyzed.
Results
Sixty-five patients were enrolled between January 2019 and December 2020. Among 49 patients with active disease at baseline (CDAI ≥150), clinical remission and clinical response at week 8 were achieved in 26 (53.1%) and 30 (61.2%) patients, respectively. At week 20, 27 (55.1%) and 35 (71.4%) patients achieved clinical remission and clinical response, respectively. Twenty-seven patients (41.5%) experienced adverse events, with serious adverse events in 3 patients (4.6%). One patient (1.5%) stopped UST therapy due to poor response. Underweight (body mass index <18.5 kg/m²) (odds ratio [OR], 0.085; 95% confidence interval [CI], 0.014–0.498; P=0.006) and elevated C-reactive protein at baseline (OR, 0.133; 95% CI, 0.022–0.823; P=0.030) were inversely associated with clinical remission at week 20.
Conclusions
UST was effective and well-tolerated as induction therapy for Korean patients with CD.

Citations

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The Korean Journal of Internal Medicine.2025; 40(2): 243. CrossRef
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Nikil Vootukuru, Abhinav Vasudevan
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Corrigendum: Real-world effectiveness and safety of ustekinumab induction therapy for Korean patients with Crohn’s disease: a KASID prospective multicenter study
Kyunghwan Oh, Hee Seung Hong, Nam Seok Ham, Jungbok Lee, Sang Hyoung Park, Suk-Kyun Yang, Hyuk Yoon, You Sun Kim, Chang Hwan Choi, Byong Duk Ye
Intestinal Research.2023; 21(2): 273. CrossRef

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Inflammatory Bowel Diseases

Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI): Tadakazu Hisamatsu, Hyo Jong Kim, Satoshi Motoya, Yasuo Suzuki, Yoshifumi Ohnishi, Noriyuki Fujii, Nobuko Matsushima, Richuan Zheng, Colleen W. Marano; Intest Res 2021;19(4):386-397. Published online December 1, 2020; DOI: https://doi.org/10.5217/ir.2020.00080

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
We aimed to evaluate the efficacy and safety of ustekinumab (UST) in the East-Asian population with moderate to severely active ulcerative colitis (UC).
Methods
This sub-analysis was conducted on data from East-Asian patients included in the UNIFI program (NCT02407236). UNIFI consisted of two double-blind, placebo-controlled trials: an 8-week induction study and a 44-week randomized withdrawal maintenance study.
Results
Of 133 East-Asian patients (Japanese: 107, Korean: 26) who underwent randomization, 131 completed induction study and 111 entered maintenance study. In the maintenance study, 78 patients were randomized. Patients who received UST 130 mg and UST 6 mg/kg showed numerically higher clinical remission at week 8 in the induction study (5/44 [11.4%] and 5/45 [11.1%], respectively) compared with those who received placebo (0/44, 0%). The proportion of patients achieved clinical remission at week 44 was numerically higher in the UST 90 mg q12w group (10/21, 47.6%), but similar in the UST 90 mg q8w group (5/26, 19.2%) compared to placebo (7/31, 22.6%). Serious adverse events were reported in 1 patient in UST 130 mg group, but no patient in UST 6 mg/kg group through week 8 in the induction study, and 1 patient in UST 90 mg q12w group and 5 patients in the UST 90 mg q8w group in the maintenance study. No deaths were reported in East-Asian patients throughout the study.
Conclusions
UST induction and maintenance treatments were effective in East-Asian patients with moderate to severe UC; the efficacy and safety profiles were consistent with the overall population.

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Inflammatory bowel diseases

Ustekinumab is effective in biological refractory Crohn’s disease patients–regardless of approval study selection criteria: Sadik Saman, Martin Goetz, Judith Wendler, Nisar P. Malek, Jan Wehkamp, Thomas Klag; Intest Res 2019;17(3):340-348. Published online May 31, 2019; DOI: https://doi.org/10.5217/ir.2019.00012

Abstract PDF PubReader ePub

Background/Aims
Ustekinumab is effective in active Crohn’s disease. In a retrospective study we assessed the clinical outcome in nonresponders to anti-tumor necrosis factor therapy, and/or conventional therapy and/or the α4β7-integrin inhibitor vedolizumab. As approval study populations do not always reflect the average “real world” patient cohort, we assessed weather patients who would not have qualified for approval studies show similar outcomes.
Methods
Forty-one patients with mild to severe active Crohn’s disease were treated with ustekinumab (intravenous 6 mg per kg/body weight) followed by subcutaneous ustekinumab (90 mg) at week 8. Depending on the clinical response maintenance therapy was chosen every 8 or 12 weeks. Clinical response was defined by Crohn’s Disease Activity Index (CDAI) decline, decline of stool frequency or clinical improvement. Inclusion criteria for approval studies were assessed.
Results
The 58.5% (24/41) showed clinical response to ustekinumab. The 58.3% of this group (14/24) achieved clinical remission. Clinical response correlated significantly with drop of stool frequency and improvement of CDAI score. The 39 out of 41 patients had no side effects and we observed no serious infections. About a third of our patients would not have met ustekinumab approval study criteria. However, patients who did not meet study criteria showed clinical improvement numerically in the same range compared to patients who would have qualified for approval studies.
Conclusions
Ustekinumab is effective, safe and well tolerated in a highly therapy refractory patient cohort. Even though a reasonable number of patients did not meet ustekinumab approval study criteria, approval study results seem to be representative to the overall patient cohort.

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Yaqing Bai, Yinghao Sun, Qi He, Xiaoyin Bai, Hong Yang
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Francesca Bello, Samer Muhsen, Haider Sabhan, Alexandra Borin, Fredrik Johansson, Charlotte Höög, Ole Forsberg, Christina Wennerström, Charlotte Söderman, Mikael Lördal, Sven Almer
Therapeutic Advances in Gastroenterology.2024;[Epub] CrossRef
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Sailish Honap, Susanna Meade, Hajir Ibraheim, Peter M. Irving, Michael P. Jones, Mark A. Samaan
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Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies: Toshifumi Hibi, Yuya Imai, Yoko Murata, Nobuko Matsushima, Richuan Zheng, Christopher Gasink; Intest Res 2017;15(4):475-486. Published online October 23, 2017; DOI: https://doi.org/10.5217/ir.2017.15.4.475

Abstract PDF Supplementary Material PubReader ePub

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

Efficacy and safety of ustekinumab were evaluated in a Japanese subpopulation with moderately to severely active Crohn's disease (CD) in UNITI-1, UNITI-2 and IM-UNITI studies and results were compared with the overall population.

Methods

Overall, patients in UNITI-1 (Japan, n=56; failed response to tumor necrosis factor antagonist) and UNITI-2 (Japan, n=26; failed response to prior conventional therapy) were randomized to placebo or ustekinumab intravenous induction (130 mg or ~6 mg/kg) at week 0. Responders to ustekinumab induction therapy (Japan, n=21) were randomized to placebo or ustekinumab (90 mg, subcutaneous) maintenance (every 12 weeks [q12w] or 8 weeks [q8w]) in IM-UNITI. The primary endpoint was clinical response at week 6 for induction studies and clinical remission at week 44 for maintenance study.

Results

Percentage of patients achieving clinical response at week 6 was greater in ustekinumab 130 mg and ~6 mg/kg groups than in the placebo group (UNITI-1: 36.8% and 31.6% vs. 27.8%, respectively, for Japanese; 34.3% and 33.7% vs. 21.5%, respectively, for overall; UNITI-2: 37.5% and 55.6% vs. 11.1%, respectively, for Japanese; 51.7% and 55.5% vs. 28.7%, respectively, for overall). Clinical remission rate at week 44 during maintenance was greater in the ustekinumab 90 mg SC q12w and q8w groups than in the placebo group (50.0% and 55.6% vs. 25.0%, respectively, for Japanese; 48.8% and 53.1% vs. 35.9%, respectively, for overall). Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population.

Conclusions

Ustekinumab could be considered as a new therapeutic option for moderately to severely active CD in Japanese patients. Both ustekinumab induction and maintenance treatments were generally well tolerated (Clinical Trial Registration: NCT01369329, NCT01369342, NCT01369355).

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Yanfang Liu, Choo Hua Goh, Hong Qiu, Kuan-Chih Huang, Hsingwen Chung, Carine Saadoun
Annals of Pharmacotherapy.2023; 57(9): 1053. CrossRef
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Kyunghwan Oh, Hee Seung Hong, Nam Seok Ham, Jungbok Lee, Sang Hyoung Park, Suk-Kyun Yang, Hyuk Yoon, You Sun Kim, Chang Hwan Choi, Byong Duk Ye
Intestinal Research.2023; 21(1): 137. CrossRef
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Sophie Vieujean, Edouard Louis, Silvio Danese, Laurent Peyrin-Biroulet
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