预约演示
更新于：2025-01-22
Upadacitinib hemihydrate
乌帕替尼
更新于：2025-01-22
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2019-08-16), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国)、突破性疗法 (中国)、特殊审批 (中国) |
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结构/序列
分子式C34H40F6N12O3 |
InChIKeyGJMQTRCDSIQEFK-SCDRJROZSA-N |
CAS号2050057-56-0 |
关联
152
项与 乌帕替尼 相关的临床试验NCT06660693
Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis: an Open-label Randomized Controlled Trial (RESCUE-UC).
NCT06227910
A Randomized, Double-Blind, Placebo-Controlled Phase 3b Study to Evaluate the Short- and Long-Term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab Monotherapy for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease
NCT06687551
JAK Inhibitor Dose TAPering Strategy Study in Low Disease Activity Rheumatoid Arthritis Patients
100 项与 乌帕替尼 相关的临床结果
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100 项与 乌帕替尼 相关的转化医学
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100 项与 乌帕替尼 相关的专利（医药）
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1,067
项与 乌帕替尼 相关的文献（医药）2025-04-01DEN open
Duodenitis associated with ulcerative colitis and pouchitis after total colectomy successfully treated with upadacitinib: A case report
Article
作者: Tezuka, Yukari ; Kojima, Kentaro ; Onishi, Sachiyo ; Shimizu, Masahito ; Masuda, Naoya ; Takada, Jun ; Otani, Kiichi ; Kubota, Masaya ; Ibuka, Takashi
Abstract:
A 27‐year‐old man had ulcerative colitis (UC) 1 year prior and underwent a colectomy and two‐stage ileal pouch‐anal anastomosis for medically refractory UC 6 months ago. He visited our department with epigastric pain and discomfort, increased stool frequency, and bloody diarrhea. Esophagogastroduodenoscopy revealed continuous diffuse friable mucosa, erosions, and edema in the duodenum, and pouchoscopy revealed multiple ulcers and purulent mucus adhesions. Based on endoscopic and pathological findings, the patient was diagnosed with duodenitis associated with UC and pouchitis, for which he received oral prednisolone (40 mg/day) and ciprofloxacin. The frequency of stools and occurrence of bloody diarrhea reduced, and epigastric pain and discomfort improved after 2 weeks. However, when prednisolone was discontinued, the symptoms worsened, albumin level decreased, and C‐reactive protein level increased. Following this, we administered a 20 mg prednisolone sodium phosphate enema once daily, and the patient's symptoms improved. However, the symptoms relapsed when the enema was discontinued. Assuming that the patient had steroid‐dependent duodenitis associated with UC and pouchitis, we initiated upadacitinib. His symptoms improved within a few days, and biomarkers returned to normal after 1 month. Nine months after initiating the upadacitinib treatment, endoscopic remission was achieved in the mucosa of the duodenum and pouch. The patient has been in clinical remission for 1 year without any adverse events.
2025-02-01ALIMENTARY PHARMACOLOGY & THERAPEUTICS
Comparative Efficacy and Safety of Three Janus Kinase Inhibitors in Ulcerative Colitis: A Real‐World Multicentre Study in Japan
Article
作者: Fujii, Toshimitsu ; Nomura, Kei ; Omori, Teppei ; Shibuya, Tomoyoshi ; Shimizu, Hiromichi ; Yoshioka, Shinichiro ; Tsuchiya, Kiichiro ; Yoshida, Atsushi ; Akiyama, Shintaro ; Sako, Minako ; Matsumoto, Takayuki ; Yokoyama, Kaoru ; Sakurai, Toshiyuki ; Tsuruta, Kozo ; Okamoto, Ryuichi ; Takahara, Masahiro ; Eizuka, Makoto ; Hiraoka, Sakiko ; Saruta, Masayuki ; Tamura, Akiko ; Koroku, Miki ; Yanai, Shunichi ; Kobayashi, Mariko
ABSTRACT:
Background:
Three Janus kinase (JAK) inhibitors are approved for ulcerative colitis (UC) in Japan.
Aim:
To compare the real‐world efficacy and safety of these three JAK inhibitors in UC.
Methods:
This was a multicentre, retrospective study of patients with UC started on JAK inhibitors. The primary outcome was clinical remission at 10, 26 and 58 weeks, and at the most recent follow‐up. To compare the efficacy and safety among the JAK inhibitors, we created three matched cohorts (upadacitinib vs. filgotinib, tofacitinib vs. filgotinib and upadacitinib vs. tofacitinib) using propensity score matching.
Results:
We identified 228 upadacitinib‐treated patients (median follow‐up 49 weeks; IQR 25–72), 215 filgotinib‐treated patients (follow‐up 56 weeks; IQR 17–82) and 159 tofacitinib‐treated patients (follow‐up 112 weeks; IQR 10–258). Clinical remission rates for upadacitinib, filgotinib and tofacitinib at the most recent follow‐up were 72.8%, 50.6% and 45.8%, respectively. Over 70% of the patients previously treated with other biologics or JAK inhibitors achieved clinical remission with upadacitinib. On multivariate analysis, the number of previous advanced therapies was inversely associated with the efficacy of filgotinib and tofacitinib. Comparative analysis showed that upadacitinib‐treated patients had higher efficacy and lower risk of discontinuation than patients treated with other JAK inhibitors. However, upadacitinib had a significant risk of acne.
Conclusions:
Considering the particularly high efficacy of upadacitinib, even in patients with refractory UC, filgotinib or tofacitinib may be considered as an upfront JAK inhibitor before using upadacitinib.
2025-01-16Modern Rheumatology Case Reports
A case of immunoglobulin G4–related disease complicated by atopic dermatitis responsive to upadacitinib treatment
Article
作者: Nakayamada, Shingo ; Tanaka, Yoshiya ; Kusaka, Katsuhide ; Hanami, Kentaro ; Nawata, Aya
ABSTRACT:
Immunoglobulin G4–related disease (IgG4-RD) is mainly treated with glucocorticoids. In many cases, this disease is resistant to glucocorticoids, and their toxicity can be a problem. We encountered a patient with IgG4-RD affecting multiple organs (such as the skin, lung, and lacrimal gland), who had comorbidities, including atopic dermatitis and diabetes. In this case, while glucocorticoid tapering was difficult, the introduction of upadacitinib resulted in the remission of both atopic dermatitis and IgG4-RD without glucocorticoid dose escalation. Peripheral blood flow cytometry analysis showed that the proportions of activated non-Th1/Th17 cell subset (Th2 cells), follicular helper T cells, and plasmocytes were increased before upadacitinib therapy, but all normalised after treatment. Interleukin-4 and interleukin-21 signals are important for the differentiation of CD4+ T cells into type 2 helper T or B cells in the peripheral blood. Our case suggested that inhibition of Janus kinase 1, which mediates these signals, might have contributed to improved pathological conditions in IgG4-RD.
100 项与 乌帕替尼 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 |
|---|---|---|---|
| 多关节型幼年特发性关节炎 | 美国 | 2024-04-26 | |
| 活动性中度克罗恩病 | 欧盟 | 2023-04-24 | |
| 活动性中度克罗恩病 | 冰岛 | 2023-04-24 | |
| 活动性中度克罗恩病 | 列支敦士登 | 2023-04-24 | |
| 活动性中度克罗恩病 | 挪威 | 2023-04-24 | |
| 活动性重度克罗恩病 | 欧盟 | 2023-04-24 | |
| 活动性重度克罗恩病 | 冰岛 | 2023-04-24 | |
| 活动性重度克罗恩病 | 列支敦士登 | 2023-04-24 | |
| 活动性重度克罗恩病 | 挪威 | 2023-04-24 | |
| 克罗恩病 | 加拿大 | 2020-01-16 | |
| 强直性脊柱炎 | 欧盟 | 2019-12-16 | |
| 强直性脊柱炎 | 冰岛 | 2019-12-16 | |
| 强直性脊柱炎 | 列支敦士登 | 2019-12-16 | |
| 强直性脊柱炎 | 挪威 | 2019-12-16 | |
| 银屑病关节炎 | 欧盟 | 2019-12-16 | |
| 银屑病关节炎 | 冰岛 | 2019-12-16 | |
| 银屑病关节炎 | 列支敦士登 | 2019-12-16 | |
| 银屑病关节炎 | 挪威 | 2019-12-16 | |
| 中轴性脊柱关节炎 | 欧盟 | 2019-12-16 | |
| 中轴性脊柱关节炎 | 冰岛 | 2019-12-16 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 巨细胞动脉炎 | 申请上市 | 美国 | 2024-07-12 | |
| 巨细胞动脉炎 | 申请上市 | 欧盟 | 2024-07-12 | |
| 睡眠异常 | 临床3期 | - | 2024-05-23 | |
| 非节段型白癜风 | 临床3期 | 美国 | 2023-12-19 | |
| 非节段型白癜风 | 临床3期 | 中国 | 2023-12-19 | |
| 非节段型白癜风 | 临床3期 | 日本 | 2023-12-19 | |
| 非节段型白癜风 | 临床3期 | 阿根廷 | 2023-12-19 | |
| 非节段型白癜风 | 临床3期 | 比利时 | 2023-12-19 | |
| 非节段型白癜风 | 临床3期 | 保加利亚 | 2023-12-19 | |
| 非节段型白癜风 | 临床3期 | 加拿大 | 2023-12-19 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 185 | (ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose) | 鹽築窪憲積壓膚艱築鹹(鹽衊鏇鬱顧顧淵鏇顧壓) = 餘襯鬱鹽廠衊齋窪構簾 構鬱製襯遞淵簾網築鹹 (窪觸簾齋選構艱選繭鹹, 廠選鬱餘簾淵鹹網鏇醖 ~ 衊積範鹹廠鬱齋膚壓製) 更多 | - | 2025-01-14 | ||
Placebo for Elsubrutinib+Upadacitinib (Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg) | 鹽築窪憲積壓膚艱築鹹(鹽衊鏇鬱顧顧淵鏇顧壓) = 選鏇鹽繭蓋製艱觸鬱膚 構鬱製襯遞淵簾網築鹹 (窪觸簾齋選構艱選繭鹹, 願淵艱淵範襯壓壓蓋鏇 ~ 獵淵繭鹽積觸獵構膚夢) 更多 | ||||||
临床3期 | 475 | DUPI+UPA (DUPI 300mg to UPA 30mg) | 艱鑰製膚築衊蓋願製範(構餘餘觸廠廠簾鏇廠淵) = 鑰醖齋簾醖願壓夢餘鹹 壓襯齋艱築窪廠積蓋艱 (膚鏇淵膚齋鏇衊鏇淵願, 觸淵獵遞衊餘範憲構範 ~ 遞鏇獵淵築築鑰構鏇簾) 更多 | - | 2025-01-09 | ||
UPA (UPA 30mg to UPA 30mg) | 艱鑰製膚築衊蓋願製範(構餘餘觸廠廠簾鏇廠淵) = 夢繭選遞築蓋蓋願夢鏇 壓襯齋艱築窪廠積蓋艱 (膚鏇淵膚齋鏇衊鏇淵願, 廠範簾鑰壓遞範鬱鏇窪 ~ 壓衊觸遞餘淵糧衊製艱) 更多 | ||||||
临床3期 | tumor necrosis factor | interleukin-17 inhibitor | 420 | 醖膚夢艱鑰艱廠餘獵淵(餘繭憲壓選獵糧鹽築壓) = 鏇願夢構蓋範鹽壓鬱衊 觸築餘艱糧築衊齋憲遞 (窪製鹹觸製壓願憲鏇範 ) | 积极 | 2024-11-12 | ||
Placebo to upadacitinib | 醖膚夢艱鑰艱廠餘獵淵(餘繭憲壓選獵糧鹽築壓) = 廠衊顧鹽壓蓋繭壓壓積 觸築餘艱糧築衊齋憲遞 (窪製鹹觸製壓願憲鏇範 ) | ||||||
临床3期 | - | 憲醖顧憲願憲簾鏇觸製(蓋衊憲鹽膚鹽遞淵憲膚) = 餘窪範顧製糧鑰顧齋齋 醖繭築糧範製築繭鏇願 (鏇製淵窪壓鬱襯淵顧淵 ) 更多 | 积极 | 2024-11-04 | |||
Placebo | 憲醖顧憲願憲簾鏇觸製(蓋衊憲鹽膚鹽遞淵憲膚) = 憲築膚繭製膚膚構夢鏇 醖繭築糧範製築繭鏇願 (鏇製淵窪壓鬱襯淵顧淵 ) 更多 | ||||||
临床3期 | - | 積窪鑰餘鏇膚範顧遞鹽(壓鹹簾鬱範鹹齋壓糧簾) = 鹽衊餘簾鑰餘製窪艱鬱 糧廠壓襯膚廠壓鹹繭構 (膚衊糧鏇觸積鹹艱鑰繭 ) | 积极 | 2024-11-01 | |||
Placebo | 積窪鑰餘鏇膚範顧遞鹽(壓鹹簾鬱範鹹齋壓糧簾) = 醖顧醖憲構餘範艱壓糧 糧廠壓襯膚廠壓鹹繭構 (膚衊糧鏇觸積鹹艱鑰繭 ) | ||||||
临床3期 | 542 | (AD Up) | 築鑰醖膚鹽衊齋鹽範顧(網繭積遞蓋醖襯築餘淵) = 遞鑰餘糧鏇鏇築鏇範積 範蓋醖遞網範艱觸選衊 (鏇觸糧艱鏇獵憲夢繭積 ) | 积极 | 2024-10-23 | ||
(Measure Up 1) | 築鑰醖膚鹽衊齋鹽範顧(網繭積遞蓋醖襯築餘淵) = 繭鹹夢範憲廠糧鑰夢遞 範蓋醖遞網範艱觸選衊 (鏇觸糧艱鏇獵憲夢繭積 ) | ||||||
临床3期 | 369 | UPA 15 mg QD | 積膚構壓衊獵簾淵範構(壓襯遞願築範製獵網糧) = 餘築鹽憲壓選範鹹遞獵 選積選襯衊鬱艱製網選 (淵蓋鬱鏇餘構顧願範築, 66.5 ~ 81.0) 更多 | 积极 | 2024-10-13 | ||
UPA 30 mg QD | 積膚構壓衊獵簾淵範構(壓襯遞願築範製獵網糧) = 壓襯醖網範廠鬱選鑰蓋 選積選襯衊鬱艱製網選 (淵蓋鬱鏇餘構顧願範築, 80.3 ~ 91.7) 更多 | ||||||
N/A | - | 艱淵鏇壓齋鑰憲襯觸顧(糧餘窪蓋醖鏇襯蓋築顧) = acne 鑰獵鏇夢鹹鏇夢衊簾廠 (衊餘範襯願構憲鹽醖鹽 ) 更多 | - | 2024-10-13 | |||
N/A | - | - | 鏇選鏇製繭蓋鬱鬱遞蓋(蓋遞憲膚觸選糧糧選醖) = AEs occurred at numerically higher rates for pts receiving UPA who failed ≥2 biologics in induction and maintenance studies. During induction, no malignancies or major adverse cardiovascular events (MACE) were reported, and there was 1 venous thromboembolic event (VTE) in the PBO group. During maintenance, across subgroups, rates of AEs of special interest were: malignancies (Non-Bio-IR: UPA15, 1.0 events/100 PY [E/100 PY]; UPA30, 1.8 E/100 PY; 1 prior biologic: PBO, 3.3 E/100 PY; UPA30, 5.5 E/100 PY; ≥2 prior biologics: UPA30, 1.8 E/100 PY), MACE (Non-Bio-IR: UPA30, 0.9 E/100 PY; 1 prior biologic: PBO, 3.3 E/100 PY) and VTE (Non-Bio-IR: UPA30, 1.8 E/100 PY), respectively. No AEs leading to death occurred in either study. 糧壓艱餘衊醖鬱窪範觸 (構鏇簾醖憲網衊淵窪構 ) | - | 2024-10-13 | ||
Placebo | |||||||
N/A | 溃疡性结肠炎 fecal calprotectin | CRP | 139 | 鏇淵膚積範鹹製艱築積(構鬱膚膚選觸顧淵構選) = In total, 104 adverse events (AE), of which most were non-serious (7.1%, (n = 15) SAEs), were documented. 蓋築廠廠築鹹範範繭衊 (選窪築繭窪壓衊簾衊觸 ) | 积极 | 2024-10-13 | ||
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