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- Real-world data for golimumab treatment in patients with ulcerative colitis in Japan: interim analysis in post-marketing surveillance
- Shiro Nakamura, Teita Asano, Hiroaki Tsuchiya, Kanami Sugimoto, Yuya Imai, Seiji Yokoyama, Yasuo Suzuki
- Intest Res 2022;20(3):329-341. Published online August 4, 2021
- DOI: https://doi.org/10.5217/ir.2021.00032
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Abstract
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Supplementary Material
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ePub - Background/Aims
Golimumab (GLM) is an anti-tumor necrosis factor-α drug approved for treating moderate-to-severe active ulcerative colitis (UC). A 52-week post-marketing surveillance (PMS) was initiated to evaluate its safety and effectiveness in patients with UC in Japan. We present an interim report of the ongoing PMS.
Methods
Patients received 200 mg of subcutaneous GLM at week 0, 100 mg at week 2, and 100 mg 4 weekly thereafter. The safety analysis set included 392 patients with UC, and the effectiveness analysis set 387 patients. Safety and effectiveness were assessed at week 6.
Results
Adverse drug reactions (ADRs) were reported in 8.2% (32/392) and serious ADRs in 4.6% (18/392). The most frequent ADRs were infection and infestation (3.3%), with herpes zoster being the most common. ADRs were significantly higher in patients with concomitant corticosteroid use (odds ratio [OR], 3.45; 95% confidence interval [CI], 1.40–9.68). No significant difference in ADR incidence was observed between patients aged ≥65 and <65 years (OR, 1.23; 95% CI, 0.35–3.47). Six-week effectiveness of GLM was confirmed by a decrease in the partial Mayo score (–2.3; 95% CI, –2.6 to –2.1) and C-reactive protein levels (–0.64; 95% CI, –0.92 to –0.36), including in the biologics-experienced population.
Conclusions
The safety and effectiveness of GLM at week 6 in a real-world setting were demonstrated in patients with UC in Japan. ADR patterns were consistent with previous reports with no new safety signals. Concomitant corticosteroid use may be associated with increased ADR incidence. The final results of the ongoing PMS are necessary for further evaluation. -
Citations
Citations to this article as recorded by
- Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review
Peter M. Irving, Peter Hur, Raju Gautam, Xiang Guo, Severine Vermeire
Journal of Managed Care & Specialty Pharmacy.2024; 30(9): 1026. 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 - Golimumab for Ulcerative Colitis: One More Option to SAVE the Colon
Sang Hyoung Park
Crohn's & Colitis 360.2023;[Epub] CrossRef - Advancements in the Management of Moderate-to-Severe Ulcerative Colitis: A Revised 2023 Korean Treatment Guidelines
Soo-Young Na
The Korean Journal of Medicine.2023; 98(5): 223. CrossRef - Pharmacogenetics-based personalized treatment in patients with inflammatory bowel disease: A review
Ji Young Chang, Jae Hee Cheon
Precision and Future Medicine.2021; 5(4): 151. CrossRef
- Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review
- 5,010 View
- 659 Download
- 3 Web of Science
- 5 Crossref
- 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
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Abstract
PDFSupplementary MaterialPubReaderePub
<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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Citations
Citations to this article as recorded by- Saudi consensus guidance for the diagnosis and management of inflammatory bowel disease in children and adolescents
Omar I. Saadah, Turki AlAmeel, Ahmed Al Sarkhy, Mohammed Hasosah, Abdulrahman Al-Hussaini, Majid A. Almadi, Badr Al-Bawardy, Talal A. Altuwaijri, Mohammed AlEdreesi, Shakir A. Bakkari, Othman R. Alharbi, Nahla A. Azzam, Abdulelah Almutairdi, Khalidah A. A
Saudi Journal of Gastroenterology.2024;[Epub] CrossRef - The treatment of inflammatory bowel disease with monoclonal antibodies in Asia
Yu Chen, Guolin Zhang, Yuewen Yang, Shuangshuang Zhang, Haozheng Jiang, Kang Tian, Arenbaoligao, Dapeng Chen
Biomedicine & Pharmacotherapy.2023; 157: 114081. CrossRef - A Retrospective Cohort Study of Clinical Features and Treatment Patterns With Ustekinumab in Patients With Crohn Disease Utilizing a Health Care Database in Japan
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 - 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 - Feasibility of a Clinical Decision Support Tool for Ustekinumab to Predict Clinical Remission and Relapse in Patients With Crohn’s Disease: A Multicenter Observational Study
Jihye Park, Jaeyoung Chun, Hyuk Yoon, Jae Hee Cheon
Inflammatory Bowel Diseases.2022;[Epub] 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 - Association of Anti–Tumor Necrosis Factor Therapy With Mortality Among Veterans With Inflammatory Bowel Disease
Shirley Cohen-Mekelburg, Beth I. Wallace, Tony Van, Wyndy L. Wiitala, Shail M. Govani, Jennifer Burns, Rachel Lipson, Huifeng Yun, Jason Hou, James D. Lewis, Jason A. Dominitz, Akbar K. Waljee
JAMA Network Open.2021; 4(3): e210313. CrossRef - Evidence-based clinical practice guidelines for inflammatory bowel disease 2020
Hiroshi Nakase, Motoi Uchino, Shinichiro Shinzaki, Minoru Matsuura, Katsuyoshi Matsuoka, Taku Kobayashi, Masayuki Saruta, Fumihito Hirai, Keisuke Hata, Sakiko Hiraoka, Motohiro Esaki, Ken Sugimoto, Toshimitsu Fuji, Kenji Watanabe, Shiro Nakamura, Nagamu I
Journal of Gastroenterology.2021; 56(6): 489. CrossRef - Safety and effectiveness of ustekinumab in Crohn's disease: Interim results of post‐marketing surveillance in Japan
Seiji Yokoyama, Teita Asano, Katsumasa Nagano, Hiroaki Tsuchiya, Masayuki Takagishi, Shigeharu Tsujioka, Naomi Miura, Takayuki Matsumoto
Journal of Gastroenterology and Hepatology.2021; 36(11): 3069. CrossRef - Translating Treg Therapy for Inflammatory Bowel Disease in Humanized Mice
Sushmita Negi, Sheetal Saini, Nikunj Tandel, Kiran Sahu, Ravi P.N. Mishra, Rajeev K. Tyagi
Cells.2021; 10(8): 1847. CrossRef - 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
Intestinal Research.2021; 19(4): 386. CrossRef - Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis
Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi
Intestinal Research.2021; 19(4): 448. CrossRef - Interleukin 23 and autoimmune diseases: current and possible future therapies
Ahmad Ismail Khaled Abdo, Gee Jun Tye
Inflammation Research.2020; 69(5): 463. CrossRef - Long-Term Clinical Effectiveness of Ustekinumab in Patients With Crohn’s Disease: A Retrospective Cohort Study
Takahiro Ito, Atsuo Maemoto, Takehiko Katsurada, Hiroki Tanaka, Satoshi Motoya, Nobuhiro Ueno, Mikihiro Fujiya, Toshifumi Ashida, Daisuke Hirayama, Hiroshi Nakase
Crohn's & Colitis 360.2020;[Epub] CrossRef - Novel drug delivery systems of Chinese medicine for the treatment of inflammatory bowel disease
Caifang Gao, Lijuan Liu, Yangyang Zhou, Zhaoxiang Bian, Shengpeng Wang, Yitao Wang
Chinese Medicine.2019;[Epub] CrossRef - 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
Intestinal Research.2019; 17(3): 340. CrossRef - Perspectives on Current and Novel Treatments for Inflammatory Bowel Disease
Soo-Young Na, Won Moon
Gut and Liver.2019; 13(6): 604. CrossRef - Anti-IL-12/23p40 antibodies for maintenance of remission in Crohn's disease
Sarah C Davies, Tran M Nguyen, Claire E Parker, John K MacDonald, Vipul Jairath, Reena Khanna
Cochrane Database of Systematic Reviews.2019;[Epub] CrossRef - Novel treatments for inflammatory bowel disease
Hyo Sun Lee, Soo-Kyung Park, Dong Il Park
The Korean Journal of Internal Medicine.2018; 33(1): 20. CrossRef - Emerging Therapies: What Are Promising in the Near Future?
Geom Seog Seo, Sung Hee Lee
The Korean Journal of Gastroenterology.2018; 71(2): 81. CrossRef
- Saudi consensus guidance for the diagnosis and management of inflammatory bowel disease in children and adolescents
- 6,439 View
- 141 Download
- 18 Web of Science
- 21 Crossref
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