Intestinal Research

Original Articles

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

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

Citations to this article as recorded by

Long-term real-world data of ustekinumab in Crohn’s disease: the Stockholm ustekinumab study
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
Approach to loss of response to advanced therapies in inflammatory bowel disease
Nikil Vootukuru, Abhinav Vasudevan
World Journal of Gastroenterology.2024; 30(22): 2902. CrossRef
One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn’s Disease: The K-STAR Study
Chang Kyun Lee, Won Moon, Jaeyoung Chun, Eun Soo Kim, Hyung Wook Kim, Hyuk Yoon, Hyun Soo Kim, Yoo Jin Lee, Chang Hwan Choi, Yunho Jung, Sung Chul Park, Geun Am Song, Jong Hun Lee, Eun Suk Jung, Youngdoe Kim, Su Young Jung, Jong Min Choi, Byong Duk Ye
Inflammatory Bowel Diseases.2024;[Epub] CrossRef
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

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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.

Citations

Citations to this article as recorded by

Systematic Review and Meta-analysis: The Association Between Serum Ustekinumab Trough Concentrations and Treatment Response in Inflammatory Bowel Disease
Abhinav Vasudevan, Vivek Tharayil, Laura H Raffals, David H Bruining, Michelle Becker, Mohammad Hassan Murad, Edward V Loftus
Inflammatory Bowel Diseases.2024; 30(4): 660. CrossRef
Machine learning using clinical data at baseline predicts the medium-term efficacy of ustekinumab in patients with ulcerative colitis
Hiromu Morikubo, Ryuta Tojima, Tsubasa Maeda, Katsuyoshi Matsuoka, Minoru Matsuura, Jun Miyoshi, Satoshi Tamura, Tadakazu Hisamatsu
Scientific Reports.2024;[Epub] CrossRef
Hepatic Steatosis but Not Fibrosis Is Independently Associated with Poor Outcomes in Patients with Inflammatory Bowel Disease
Hye Kyung Hyun, Hye Won Lee, Jihye Park, Soo Jung Park, Jae Jun Park, Tae Il Kim, Jae Seung Lee, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Seung Up Kim, Jae Hee Cheon
Gut and Liver.2024; 18(2): 294. CrossRef
Machine Learning for Predicting Biologic Agent Efficacy in Ulcerative Colitis: An Analysis for Generalizability and Combination with Computational Models
Philippe Pinton
Diagnostics.2024; 14(13): 1324. CrossRef
One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn’s Disease: The K-STAR Study
Chang Kyun Lee, Won Moon, Jaeyoung Chun, Eun Soo Kim, Hyung Wook Kim, Hyuk Yoon, Hyun Soo Kim, Yoo Jin Lee, Chang Hwan Choi, Yunho Jung, Sung Chul Park, Geun Am Song, Jong Hun Lee, Eun Suk Jung, Youngdoe Kim, Su Young Jung, Jong Min Choi, Byong Duk Ye
Inflammatory Bowel Diseases.2024;[Epub] CrossRef
Risks of colorectal cancer and biliary cancer according to accompanied primary sclerosing cholangitis in Korean patients with ulcerative colitis: a nationwide population-based study
Eun Hye Oh, Ye-Jee Kim, Minju Kim, Seung Ha Park, Tae Oh Kim, Sang Hyoung Park
Intestinal Research.2023; 21(2): 252. CrossRef
A critical review of ustekinumab for the treatment of active ulcerative colitis in adults
Sophie Vieujean, Edouard Louis, Silvio Danese, Laurent Peyrin-Biroulet
Expert Review of Gastroenterology & Hepatology.2023; 17(5): 413. CrossRef
Reviewing not Homer’s Iliad, but “Kai Bao Ben Cao”: indigo dye—the past, present, and future
Yusuke Yoshimatsu, Tomohisa Sujino, Takanori Kanai
Intestinal Research.2023; 21(2): 174. CrossRef
Concomitant ankylosing spondylitis can increase the risk of biologics or small molecule therapies to control inflammatory bowel disease
Yu Kyung Jun, Hyuk Yoon, Seong-Joon Koh, A Hyeon Kim, Kwang Woo Kim, Jun Won Park, Hyun Jung Lee, Hyoun Woo Kang, Jong Pil Im, Young Soo Park, Joo Sung Kim
Intestinal Research.2023; 21(2): 244. CrossRef
The Risk of Tuberculosis in Patients With Inflammatory Bowel Disease Treated With Vedolizumab or Ustekinumab in Korea
Myeong Geun Choi, Byong Duk Ye, Suk-Kyun Yang, Tae Sun Shim, Kyung-Wook Jo, Sang Hyoung Park
Journal of Korean Medical Science.2022;[Epub] CrossRef
Japanese pediatric patient with moderately active ulcerative colitis successfully treated with ustekinumab
Toshihiko Kakiuchi, Masato Yoshiura
Medicine.2022; 101(7): e28873. CrossRef
Personalized medicine in inflammatory bowel disease: Perspectives on Asia
Su Hyun Park, Sang Hyoung Park
Journal of Gastroenterology and Hepatology.2022; 37(8): 1434. CrossRef
Antitumor necrosis factor treatment in patients with inflammatory bowel disease does not promote psoriasis development: A meta-analysis
Yu Kyung Jun, Joo Young Park, Seong-Joon Koh, Hyunsun Park, Hyoun Woo Kang, Jong Pil Im, Joo Sung Kim
Medicine.2022; 101(27): e29872. CrossRef
Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef
Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study
Jongwook Yu, Soo Jung Park, Hyung Wook Kim, Yun Jeong Lim, Jihye Park, Jae Myung Cha, Byong Duk Ye, Tae Oh Kim, Hyun-Soo Kim, Hyun Seok Lee, Su Young Jung, Youngdoe Kim, Chang Hwan Choi
Gut and Liver.2022; 16(5): 764. CrossRef
Management of inflammatory bowel disease beyond tumor necrosis factor inhibitors: novel biologics and small-molecule drugs
Soo-Young Na, You Sun Kim
The Korean Journal of Internal Medicine.2022; 37(5): 906. CrossRef
Natural history of inflammatory bowel disease: a comparison between the East and the West
Eun Mi Song, Suk-Kyun Yang
Intestinal Research.2022; 20(4): 418. CrossRef
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Suk-Kyun Yang
Journal of the Korean Medical Association.2021; 64(9): 572. CrossRef

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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.

Citations

Citations to this article as recorded by

Comparative effectiveness and safety of ustekinumab at different intervals of maintenance phase in inflammatory bowel disease: a systematic review and meta-analysis
Yaqing Bai, Yinghao Sun, Qi He, Xiaoyin Bai, Hong Yang
European Journal of Gastroenterology & Hepatology.2024; 36(4): 359. CrossRef
Long-term real-world data of ustekinumab in Crohn’s disease: the Stockholm ustekinumab study
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
Effectiveness and Safety of Ustekinumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis
Sailish Honap, Susanna Meade, Hajir Ibraheim, Peter M. Irving, Michael P. Jones, Mark A. Samaan
Digestive Diseases and Sciences.2022; 67(3): 1018. CrossRef
Systematic review with meta‐analysis: loss of response and requirement of ustekinumab dose escalation in inflammatory bowel diseases
Hongsheng Yang, Bingyang Li, Qin Guo, Jian Tang, Bo Peng, Ni Ding, Miao Li, Qingfang Yang, Zicheng Huang, Na Diao, Xia Zhu, Jun Deng, Huili Guo, Pinjin Hu, Kang Chao, Xiang Gao
Alimentary Pharmacology & Therapeutics.2022; 55(7): 764. CrossRef
Clinically reversible ustekinumab-induced encephalopathy: case report and review of the literature
Jordi Sarto, Berta Caballol, Joan Berenguer, Iban Aldecoa, Álvaro Carbayo, Daniel Santana, Ivan Archilla, Carles Gaig, Francesc Graus, Julián Panés, Albert Saiz
Therapeutic Advances in Neurological Disorders.2022; 15: 175628642210796. CrossRef
Safety and Efficacy of Ustekinumab in the Treatment of Crohn Disease: A Systematic Review and Meta-analysis
Mohammed Assem Khorshid, Ahmed Cordie, Sherief Abd-Elsalam
Journal of Coloproctology.2022; 42(02): 178. CrossRef
Real-World Evidence of the Effectiveness and Safety of Ustekinumab for the Treatment of Crohn’s Disease: Systematic Review and Meta-Analysis of Observational Studies
Cristina Rubín de Célix, María Chaparro, Javier P. Gisbert
Journal of Clinical Medicine.2022; 11(14): 4202. CrossRef
Management of inflammatory bowel disease beyond tumor necrosis factor inhibitors: novel biologics and small-molecule drugs
Soo-Young Na, You Sun Kim
The Korean Journal of Internal Medicine.2022; 37(5): 906. CrossRef
Prospective observational study on Stelara (ustekinumab) assessing effectiveness in Crohn’s disease (PROSE): a 16-week follow-up
Anders Forss, Mark Clements, Pär Myrelid, Hans Strid, Charlotte Söderman, Agnieszka Wagner, David Andersson, Fredrik Hjelm, Ola Olén, Jonas F. Ludvigsson, Jonas Halfvarson
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Seungwon Yang, Siyoung Yang, Young Kwon Jo, Seungyeon Kim, Min Jung Chang, Junjeong Choi, Jae Hee Cheon, Yun Mi Yu
Therapeutic Advances in Chronic Disease.2021;[Epub] CrossRef
Treatment of inflammatory bowel diseases: focusing on biologic agents and new therapies
Hyo Yeop Song, Geom Seog Seo
Journal of the Korean Medical Association.2021; 64(9): 605. CrossRef
Eficacia y seguridad de ustekinumab en la práctica clínica real. Estudio multicéntrico retrospectivo. Cohorte ARAINF
Diego Casas Deza, Santiago García López, Miguel Lafuente Blasco, Raquel Vicente Lidón, Juan Nerín de la Puerta, Elena Peña Gonzalez, Yolanda Ber Nieto, Mara Charro Calvillo, María José Alcalá Escriche, Fernando Gomollón García, Maite Arroyo Villarino
Gastroenterología y Hepatología.2020; 43(3): 126. CrossRef
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Fabio Salvatore Macaluso, Marcello Maida, Marco Ventimiglia, Mario Cottone, Ambrogio Orlando
Expert Opinion on Biological Therapy.2020; 20(2): 193. CrossRef
Efficacy and safety of ustekinumab in real clinical practice. Retrospective multicentre study. ARAINF cohort
Diego Casas Deza, Santiago García López, Miguel Lafuente Blasco, Raquel Vicente Lidón, Juan Nerín de la Puerta, Elena Peña Gonzalez, Yolanda Ber Nieto, Mara Charro Calvillo, María José Alcalá Escriche, Fernando Gomollón García, Maite Arroyo Villarino
Gastroenterología y Hepatología (English Edition).2020; 43(3): 126. CrossRef
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Cristina Saldaña Dueñas, María Rullán Iriarte, Alfonso Elosua González, Cristina Rodríguez Gutiérrez, Saioa Rubio Iturria, Óscar Nantes Castillejo
Gastroenterología y Hepatología.2020; 43(9): 497. CrossRef
Real‐world long‐term effectiveness of ustekinumab in Crohn's disease: results from the ENEIDA registry
Marisa Iborra, Belén Beltrán, Agnes Fernández‐Clotet, Eva Iglesias‐Flores, Pablo Navarro, Montserrat Rivero, Ana Gutiérrez, Mónica Sierra‐Ausin, Francisco Mesonero, Rocío Ferreiro‐Iglesias, Joaquín Hinojosa, Xavier Calvet, Beatriz Sicilia, Carlos González
Alimentary Pharmacology & Therapeutics.2020; 52(6): 1017. CrossRef
Objectively assessed disease activity and drug persistence during ustekinumab treatment in a nationwide real-world Crohn’s disease cohort
Clas-Göran af Björkesten, Tuire Ilus, Taru Hallinen, Erkki Soini, Anja Eberl, Kalle Hakala, Mikko Heikura, Airi Jussila, Ritva Koskela, Inka Koskinen, Veikko Moilanen, Christian Nielsen, Urpo Nieminen, Heikki Nuutinen, Markku Heikkinen, Ulla-Maija Suhonen
European Journal of Gastroenterology & Hepatology.2020; 32(12): 1507. CrossRef
Ustekinumab in Crohn's disease: Effectiveness and safety in clinical practice
Cristina Saldaña Dueñas, María Rullán Iriarte, Alfonso Elosua González, Cristina Rodríguez Gutiérrez, Saioa Rubio Iturria, Óscar Nantes Castillejo
Gastroenterología y Hepatología (English Edition).2020; 43(9): 497. CrossRef
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Alimentary Pharmacology & Therapeutics.2019; 50(5): 600. CrossRef

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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).

Citations

Citations to this article as recorded by

Saudi consensus guidance for the diagnosis and management of inflammatory bowel disease in children and adolescents
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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
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(1): 137. CrossRef
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Sophie Vieujean, Edouard Louis, Silvio Danese, Laurent Peyrin-Biroulet
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Safety and effectiveness of ustekinumab in Crohn's disease: Interim results of post‐marketing surveillance in Japan
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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
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