预约演示
更新于：2025-11-14
Ustekinumab
乌司奴单抗
更新于：2025-11-14
概要
基本信息
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、临床急需境外新药 (中国)、孤儿药 (日本) |
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结构/序列
Sequence Code 143665H
来源: *****
Sequence Code 143874L
来源: *****
关联
175
项与 乌司奴单抗 相关的临床试验NCT06807593
Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
NCT07138898
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
NCT06788340
MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - An Independent Randomized Controlled Trial
100 项与 乌司奴单抗 相关的临床结果
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100 项与 乌司奴单抗 相关的转化医学
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100 项与 乌司奴单抗 相关的专利（医药）
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3,434
项与 乌司奴单抗 相关的文献（医药）2025-12-31JOURNAL OF MEDICAL ECONOMICS
Cost per remission for mirikizumab versus ustekinumab for moderately to severely active ulcerative colitis treatment from the United States commercial payer perspective
Article
作者: Upadhyay, Navneet ; Creveling, Thomas ; Fisher, Deborah A. ; Mittal, Neha ; Bires, Nicholas ; Chanan, Neha ; Kane, Sunanda ; Gulati, Ankit ; Koushik, Amit Kumar
INTRODUCTION:
Mirikizumab, approved for the treatment of moderately to severely active ulcerative colitis (UC), may be prescribed in a similar placement to ustekinumab in second-line settings. Payers may compare the economic value when making formulary decisions. This study estimated and compared the cost per remission of the second-line therapies mirikizumab versus ustekinumab in patients with UC.
METHODS:
An Excel-based analytic model was developed to estimate the cost per additional patient achieving clinical remission at the end of one year in biologic/Janus kinase inhibitor (JAKi)-experienced patients (second-line therapy) with UC from a United States commercial payer perspective. A network meta-analysis of published pivotal randomized clinical trials was used to derive the number needed to treat (NNT) for clinical response, clinical remission, and endoscopic remission/endoscopic improvement/mucosal healing for ustekinumab and mirikizumab in the study population. The model included the treatment cost (wholesale acquisition costs [WAC] and treatment administration costs) during the induction and maintenance phases. A scenario involving the availability of a ustekinumab biosimilar was also evaluated, assuming the NNT remained the same as ustekinumab but with a WAC set at 50% lower than its current WAC.
RESULTS:
The costs per patient achieving clinical remission for mirikizumab vs. ustekinumab as a second-line therapy were $461,096 vs. $67,273 during induction and $501,456 vs. $1,079,189 during maintenance. The cost per clinical remission in case of dose escalation during maintenance was lower for mirikizumab vs. ustekinumab ($501,456 vs. $1,569,127). Considering the ustekinumab 130 mg IV biosimilar, the scenario resulted in a lower cost per clinical remission for mirikizumab vs. a ustekinumab biosimilar during the maintenance phase ($501,456 vs. $539,594).
CONCLUSION:
Mirikizumab is projected to have a lower cost per remission during maintenance therapy than ustekinumab. Given the need for long-term treatment for this chronic condition, mirikizumab appears to be a cost-efficient treatment option.
2025-12-01Current gastroenterology reports
Interleukin-23 Inhibitors for Inflammatory Bowel Disease: Pivotal Trials and Practical Considerations
Review
作者: Jennings, William ; Fudman, David ; Rotondo-Trivette, Sarah
PURPOSE OF REVIEW:
This review summarizes the literature on IL-23 inhibitors for inflammatory bowel disease and the role of these agents in clinical practice.
RECENT FINDINGS:
The last decade has seen several pivotal trials investigating IL-23 inhibitors. These agents are effective in inducing and maintaining remission of moderate-to-severe inflammatory bowel disease, including among those with prior biologic failure, and have low adverse events. IL-23 inhibitors are safe and effective for treatment of moderate-to-severe inflammatory bowel disease and appear more effective than ustekinumab for Crohn's disease. The currently available IL-23 inhibitors likely have similar efficacy, but practical considerations may influence preferences.
2025-12-01IMMUNOLOGIC RESEARCH
A patient with CVID-enteropathy successfully treated with ustekinumab
Article
作者: Grammatikos, Alexandros ; Marley, Fenella ; Lockett, Melanie ; Gompels, Mark
CVID (common variable immunodeficiency) is associated with a variety of gastrointestinal disorders including those mimicking Crohn's disease and ulcerative colitis. At present there is no clear trial data for the treatment of CVID enteropathy. There are no specific recommendations for treatment; however, it is commonly treated in a similar manner to inflammatory bowel disease, with corticosteroids, 5-aminosalicylates (5-ASA), azathioprine and anti-TNF therapy all being used. We describe the case of a 54-year-old with CVID-enteropathy presenting with diarrhoea and evidence of granulomatous inflammation on colonic biopsies. He was successfully treated with ustekinumab following failure/intolerance of prednisolone, 5-ASA and azathioprine. Features of CVID-enteropathy improved both clinically and histologically, with no evidence of serious treatment-related side effects.
100 项与 乌司奴单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 溃疡性结肠炎 | 澳大利亚 | 2009-07-28 | |
| 克罗恩病 | 澳大利亚 | 2009-07-28 | |
| 银屑病关节炎 | 欧盟 | 2009-01-15 | |
| 银屑病关节炎 | 冰岛 | 2009-01-15 | |
| 银屑病关节炎 | 列支敦士登 | 2009-01-15 | |
| 银屑病关节炎 | 挪威 | 2009-01-15 | |
| 活动性中度克罗恩病 | 欧盟 | 2009-01-15 | |
| 活动性中度克罗恩病 | 冰岛 | 2009-01-15 | |
| 活动性中度克罗恩病 | 列支敦士登 | 2009-01-15 | |
| 活动性中度克罗恩病 | 挪威 | 2009-01-15 | |
| 活动性重度克罗恩病 | 欧盟 | 2009-01-15 | |
| 活动性重度克罗恩病 | 冰岛 | 2009-01-15 | |
| 活动性重度克罗恩病 | 列支敦士登 | 2009-01-15 | |
| 活动性重度克罗恩病 | 挪威 | 2009-01-15 | |
| 斑块状银屑病 | 欧盟 | 2009-01-15 | |
| 斑块状银屑病 | 冰岛 | 2009-01-15 | |
| 斑块状银屑病 | 列支敦士登 | 2009-01-15 | |
| 斑块状银屑病 | 挪威 | 2009-01-15 | |
| 活动性中度溃疡性结肠炎 | 欧盟 | 2009-01-15 | |
| 活动性中度溃疡性结肠炎 | 冰岛 | 2009-01-15 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 幼年特发性关节炎 | 临床3期 | 美国 | 2022-08-30 | |
| 幼年特发性关节炎 | 临床3期 | 阿根廷 | 2022-08-30 | |
| 幼年特发性关节炎 | 临床3期 | 丹麦 | 2022-08-30 | |
| 幼年特发性关节炎 | 临床3期 | 法国 | 2022-08-30 | |
| 幼年特发性关节炎 | 临床3期 | 德国 | 2022-08-30 | |
| 幼年特发性关节炎 | 临床3期 | 意大利 | 2022-08-30 | |
| 幼年特发性关节炎 | 临床3期 | 波兰 | 2022-08-30 | |
| 幼年特发性关节炎 | 临床3期 | 西班牙 | 2022-08-30 | |
| 幼年特发性关节炎 | 临床3期 | 土耳其 | 2022-08-30 | |
| 幼年特发性关节炎 | 临床3期 | 英国 | 2022-08-30 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 14 | 簾願鹹構蓋餘獵觸鹽鬱(鬱夢鬱蓋蓋獵夢遞鬱顧) = 積醖齋憲顧衊壓築網遞 鑰壓築鬱顧窪夢選醖鹽 (憲願鏇繭憲窪簾窪夢壓, 4.14 ~ NE) | 不佳 | 2025-03-14 | |||
Placebo | 簾願鹹構蓋餘獵觸鹽鬱(鬱夢鬱蓋蓋獵夢遞鬱顧) = 鏇網鹹鹹網鑰顧鑰糧廠 鑰壓築鬱顧窪夢選醖鹽 (憲願鏇繭憲窪簾窪夢壓, 12.14 ~ NE) | ||||||
早期临床1期 | 13 | 鹽衊壓顧鬱艱窪艱糧淵(壓齋壓鹽廠衊夢網積襯) = 築積顧衊網夢顧範膚衊 餘壓膚艱遞鏇膚繭蓋構 (餘鑰選網獵艱製獵鹹艱, 29.9) 更多 | - | 2025-02-12 | |||
临床3期 | 14 | placebo+ustekinumab (Double-blind: Placebo) | 獵遞壓襯鏇觸積窪觸顧(蓋衊觸淵窪築鹽遞艱範) = 鹹醖醖壓鏇繭繭膚鏇製 衊糧夢網觸願積鬱蓋齋 (蓋襯範膚憲積蓋選餘選, 齋選鏇淵繭衊膚鹽鏇蓋 ~ 蓋鑰膚積構繭廠繭艱構) 更多 | - | 2024-12-02 | ||
(Double-blind: Ustekinumab) | 獵遞壓襯鏇觸積窪觸顧(蓋衊觸淵窪築鹽遞艱範) = 範糧壓窪淵積膚膚鹹夢 衊糧夢網觸願積鬱蓋齋 (蓋襯範膚憲積蓋選餘選, 窪繭醖夢廠廠網鏇觸壓 ~ 夢繭夢繭鑰繭鏇築遞夢) 更多 | ||||||
N/A | 137 | 齋餘獵製選網繭膚網膚(窪憲網鬱製鬱鹽構齋壓) = 顧膚製壓獵襯壓選製淵 獵憲鹽淵網選膚積夢獵 (顧醖衊構糧築糧艱願構 ) 更多 | 积极 | 2024-11-10 | |||
临床4期 | 12 | (IV Weight-Based Induction Dose) | 鹹廠積鬱鹹廠衊壓廠鏇(築築簾鏇壓鏇簾選蓋簾) = 醖構醖鑰鹹艱淵夢蓋繭 憲夢遞餘夢醖襯積選顧 (觸鹽獵鹽製憲夢鏇壓範, 64.82) 更多 | - | 2024-11-05 | ||
(Standard Subcutaenous Dose) | 鹹廠積鬱鹹廠衊壓廠鏇(築築簾鏇壓鏇簾選蓋簾) = 鏇齋艱夢鹽憲壓鑰醖淵 憲夢遞餘夢醖襯積選顧 (觸鹽獵鹽製憲夢鏇壓範, 47.14) 更多 | ||||||
N/A | - | 築廠醖蓋艱繭顧鹽獵醖(築鏇選鹹襯膚膚糧衊鏇) = 62 adverse drug reactions were recorded in 36 patients 衊網願築鏇選鹽艱製憲 (製鬱鹽膚鹹壓廠壓觸淵 ) 更多 | - | 2024-10-13 | |||
N/A | - | 17 | 蓋衊願積繭網窪積鏇網(艱淵觸醖網廠築壓壓窪) = 衊醖齋夢遞簾鹽齋顧窪 願夢壓積鏇選遞顧糧鹹 (顧鬱膚廠積繭構襯艱願 ) | 积极 | 2024-10-13 | ||
N/A | - | 構範構襯積築憲齋願醖(鬱鏇餘艱憲願製遞窪鏇) = A total of 176 patients (28%) had at least one adverse event, with infections being the most frequent (11%). No negative impact on extraintestinal manifestations and/or immunomediated diseases was seen. 蓋壓鬱艱願願網衊艱憲 (遞衊餘網淵範製積襯餘 ) | - | 2024-10-13 | |||
N/A | - | Ustekinumab as 1st line biologic treatment | 積遞憲簾壓齋糧糧簾選(鹽鹹窪餘淵鹹構選鑰壓) = 63.9% (108/169) of patients experienced adverse events 簾顧鏇簾網壓遞鏇網壓 (鹽範構壓簾築繭壓網選 ) 更多 | - | 2024-10-13 | ||
Ustekinumab as 2nd line biologic treatment | |||||||
N/A | 27 | 鑰窪醖艱鏇鹽選醖觸鹽(窪糧觸顧鬱醖鬱鬱遞艱) = 廠醖餘艱築憲範鏇廠製 構廠醖遞繭憲齋齋憲獵 (衊獵窪鹽獵衊醖遞壓餘 ) 更多 | 积极 | 2024-10-13 |
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