更新于：2024-04-26
Tofacitinib Citrate
枸橼酸托法替布
更新于：2024-04-26
概要
基本信息
药物类型 小分子化药 |
别名 Tasocitinib、Tasocitinib citrate、TOFACITINIB + [19] |
作用机制 JAK1抑制剂(酪氨酸蛋白激酶JAK1抑制剂)、JAK2抑制剂(酪氨酸蛋白激酶JAK2抑制剂)、JAK3抑制剂(酪氨酸蛋白激酶JAK3抑制剂) |
非在研适应症 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2012-11-06), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、特殊审批 (中国) |
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结构
分子式C22H28N6O8 |
InChIKeySYIKUFDOYJFGBQ-YLAFAASESA-N |
CAS号540737-29-9 |
关联
420
项与 枸橼酸托法替布 相关的临床试验Korean Post-marketing Surveillance for Xeljanz® 5 mg Film-coated Tablets and Xeljanz® 1 mg/mL Oral Solution in Patients With Active pJIA and jPsA
CRIMSON: A Multicentre, Randomised, Sham-controlled (and Active Controlled in the USA), Double-masked, 72-week Trial to Study the Safety, Tolerability, Pharmacokinetics, and Efficacy of 3 Dosing Regimens of Intravitreal BI 764524 in Patients With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis: a Prospective, Observational Pilot Study
100 项与 枸橼酸托法替布 相关的临床结果
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100 项与 枸橼酸托法替布 相关的转化医学
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100 项与 枸橼酸托法替布 相关的专利（医药）
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2,801
项与 枸橼酸托法替布 相关的文献（医药）2024-12-31Journal of Medical Economics
Cost-effectiveness analysis of upadacitinib as a treatment option for patients with rheumatoid arthritis in the Kingdom of Saudi Arabia
Article
作者: Al-Homood, Ibrahim ; Alsaqa'aby, Mai ; Sharma, Yuvraj ; Hamad, Tharwat M ; Alzahrani, Zeyad ; Anwar, Ali ; Husain, Waleed ; Mohamed, Omneya ; Al-Abdulkarim, Hana ; Al Omari, Bedor ; Jaheen, Ahmed M ; Attar, Suzan M
AIM:
To evaluate cost-effectiveness of upadacitinib (targeted synthetic-disease modifying anti-rheumatic drug [ts-DMARD]) as first-line (1 L) treatment versus current treatment among patients with rheumatoid arthritis (RA) in the Kingdom of Saudi Arabia (KSA), who had an inadequate response to prior conventional-synthetic (csDMARDs) and/or biologic-DMARDs (bDMARDs).
METHODS:
This Excel-based model included patients with moderate (Disease Activity Score [DAS28]: >3.2 to ≤5.1) or severe RA (DAS28 > 5.1). Cost-effectiveness of current treatment (1 L: adalimumab-originator/biosimilar; second-line (2 L): other bDMARDs/tofacitinib) was compared against a new treatment involving two scenarios (1 L: upadacitinib, 2 L: adalimumab-biosimilar [scenario-1]/adalimumab-originator [scenario-2]) for a 10-year time-horizon from societal perspective. Model outcomes included direct and indirect costs, quality-adjusted life-years (QALYs), hospitalization days, number of orthopedic surgeries, and incremental cost-utility ratio (ICUR) per QALY.
RESULTS:
With the current pathway, estimated total societal costs for 100 RA patients over 10-year period were Saudi Riyal (SAR) 50,450,354 (United States dollars [USD] 13,453,428) (moderate RA) and SAR50,013,945 (USD13,337,052) (severe RA). New pathway (scenario-1) showed that in patients with moderate-to-severe RA, upadacitinib led to higher QALY gain (+8.99 and +15.63) at lower societal cost (cost difference: -SAR2,023,522 [-USD539,606] and -SAR3,373,029 [-USD899,474], respectively). Thus, as 1 L, upadacitinib projects "dominant" ICUR per QALY over current pathway. Moreover, in alternate pathway (scenario-2), upadacitinib also projects "dominant" ICUR per QALY for patient with severe RA (QALY gain: +15.63; cost difference: -SAR 164,536 [-USD43,876]). However, moderate RA was associated with additional cost of SAR1,255,696 (USD334,852) for improved QALY (+8.99) over current pathway (ICUR per QALY: SAR139,742 [USD37,264]). Both scenarios resulted in reduced hospitalization days (scenario-1: -14.83 days; scenario-2: -11.41 days) and number of orthopedic surgeries (scenario-1: -8.36; scenario-2: -6.54) for moderate-to-severe RA over the current treatment pathway.
CONCLUSION:
Upadacitinib as 1 L treatment in moderate-to-severe RA can considerably reduce healthcare resource burden in KSA, majorly due to reduced drug administration/monitoring/hospitalization/surgical and indirect costs.
2024-02-26Journal of Crohn's and Colitis
Tofacitinib Versus Oral Prednisolone for Induction of Remission in Moderately Active Ulcerative Colitis [ORCHID]: A Prospective, Open-Label, Randomized, Pilot Study
Article
作者: Chawla, Avantika ; Singh, Arshdeep ; Sood, Kriti ; Singh, Dharmatma ; Sood, Ajit ; Mahajan, Ramit ; Bansal, Namita ; Kaur, Ramandeep ; Kohli, Aditya ; Kaur, Kirandeep ; Midha, Vandana
Abstract:
Background:
Oral corticosteroids are first-line agents to induce remission in moderately active ulcerative colitis [UC], but are associated with adverse effects. We compared the efficacy and safety of tofacitinib and prednisolone for induction of remission in moderately active UC.
Methods:
This was a single-centre, prospective, open-label, randomized, active-controlled pilot study. Eligible patients [aged ≥18 years] had moderately active UC. Participants were randomly assigned to receive either prednisolone [40 mg daily, tapered by 5 mg every week] or tofacitinib [10 mg twice daily] for 8 weeks. The primary endpoint was composite remission [defined as total Mayo clinic score ≤2, with endoscopic sub-score of 0 and faecal calprotectin <100 µg/g] at 8 weeks.
Results:
Seventy-eight patients were randomly assigned to either of the treatment groups. At week 8, the proportion of patients achieving composite remission in the tofacitinib [7/43, 16.28%] and prednisolone groups [3/35, 8.57%] were not significantly different (odds ratio [OR] 2.07, 95% confidence interval [CI] 0.49–8.70; p = 0.31). The time to achieve symptomatic remission [normal stool frequency with absence of rectal bleeding] was similar (10 days, interquartile range [IQR 7–18.75] and 10 days [IQR 5–12.5] for tofacitinib and prednisolone, respectively; p = 0.25) in the two groups. One patient each in the tofacitinib and prednisolone group discontinued treatment due to development of pulmonary tuberculosis and pustular acne, respectively. One patient receiving tofacitinib developed herpes zoster, but did not require cessation of therapy. No serious adverse events or major adverse cardiovascular events were observed.
Conclusion:
In patients with moderately active UC, there was no difference in the efficacy and safety of tofacitinib and oral prednisolone for induction of remission at 8 weeks.
Trail Registration:
Clinical Trials Registry of India [CTRI/2021/10/037641]
American Journal of Gastroenterology
Rates of Adverse Events in Patients With Ulcerative Colitis Undergoing Colectomy During Treatment With Tofacitinib vs Biologics: A Multicenter Observational Study
Article
作者: Molnar, Tamas ; Bezzio, Cristina ; Drygiannakis, Ioannis ; Milla, Monica ; Ribaldone, Davide Giuseppe ; Eder, Piotr ; Savarino, Edoardo Vincenzo ; Castiglione, Fabiana ; Pugliese, Daniela ; Calella, Francesca ; Bouillon, Vincent ; Armuzzi, Alessandro ; Viola, Anna ; Oliveira, Raquel ; Melotti, Laura ; Dragoni, Gabriele ; Caprioli, Flavio ; Vieujean, Sophie ; Kagramanova, Anna ; Noviello, Daniele ; Festa, Stefano ; Fernandes, Samuel ; Viganò, Chiara ; Amiot, Aurelién ; Chaparro, María ; Truyens, Marie ; Gravina, Antonietta Gerarda ; Ellul, Pierre ; Innocenti, Tommaso ; Argyriou, Konstantinos
INTRODUCTION::
Patients with ulcerative colitis (UC) receiving immunosuppressive drugs are at substantial risk of colectomy. We aimed to assess the risk of postoperative complications of tofacitinib exposure before colectomy in comparison with biologics.
METHODS::
A multicenter, retrospective, observational study was conducted in patients with UC who underwent total colectomy for medically refractory disease, exposed to tofacitinib or a biologic before surgery. Primary outcome was the occurrence of any complication within 30 (early) and 90 (late) days after surgery. Secondary outcomes were the occurrence of infections, sepsis, surgical site complications, venous thromboembolic events (VTE), hospital readmissions, and redo surgery within the same timepoints.
RESULTS::
Three hundred one patients (64 tofacitinib, 162 anti-tumor necrosis factor-α agents, 54 vedolizumab, and 21 ustekinumab) were included. No significant differences were reported in any outcome, except for a higher rate of early VTE with anti-tumor necrosis factor-α agents (P = 0.047) and of late VTE with vedolizumab (P = 0.03). In the multivariate analysis, drug class was not associated with a higher risk of any early and late complications. Urgent colectomy increased the risk of any early (odds ratio [OR] 1.92, 95% confidence interval [CI] 1.06–3.48) complications, early hospital readmission (OR 4.79, 95% CI 1.12–20.58), and early redo surgery (OR 7.49, 95% CI 1.17–47.85). A high steroid dose increased the risk of any early complications (OR 1.96, 95% CI 1.08–3.57), early surgical site complications (OR 2.03, 95% CI 1.01–4.09), and early redo surgery (OR 7.52, 95% CI 1.42–39.82). Laparoscopic surgery decreased the risk of any early complications (OR 0.54, 95% CI 0.29–1.00), early infections (OR 0.39, 95% CI 0.18–0.85), and late hospital readmissions (OR 0.34, 95% CI 0.12–1.00).
DISCUSSION::
Preoperative tofacitinib treatment demonstrated a postoperative safety profile comparable with biologics in patients with UC undergoing colectomy.
449
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100 项与 枸橼酸托法替布 相关的药物交易
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 类风湿关节炎 | 批准上市 | 冰岛 更多 | |
| 幼年型关节炎 | 批准上市 | 挪威 更多 | |
| 溃疡性结肠炎 | 批准上市 | 列支敦士登 更多 | |
| 全身型幼年特发性关节炎 | 临床3期 | 波兰 更多 | |
| 斑块状银屑病 | 终止 | 瑞士 更多 |
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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1期 | - | 範鹽衊構鹽簾鹹窪簾選(觸鏇餘淵夢鹽膚廠廠壓) = 鏇壓蓋獵艱積夢衊膚獵 淵繭網鬱簾網糧構築鑰 (餘鏇壓網鬱糧鬱蓋繭遞 ) 更多 | 积极 | 2024-04-04 | |||
临床2期 | 6 | 觸選顧選襯鹽製鹹鏇獵(鑰積憲鬱獵襯糧鬱膚鹽) = 憲憲鑰鏇鏇鹽襯簾積淵 簾齋築襯簾憲夢範願衊 (襯餘鬱窪鏇窪廠鬱醖膚, 構觸蓋艱遞蓋壓壓範顧 ~ 蓋鬱廠積齋積窪窪夢網) 更多 | - | 2024-04-04 | |||
临床3期 | 204 | (Tofacitinib) | 築鏇憲襯鑰網憲選蓋夢(製艱願憲艱願蓋廠網壓) = 願願窪觸鬱製齋選製淵 廠糧願構醖構齋壓壓餘 (廠襯築範獵網鑰壓鏇獵, 淵餘鑰鬱廠鏇壓簾遞艱 ~ 齋餘淵選廠遞鹹鹽遞蓋) 更多 | - | 2024-02-08 | ||
Placebo+Tofacitinib (Placebo Then Tofacitinib) | 築鏇憲襯鑰網憲選蓋夢(製艱願憲艱願蓋廠網壓) = 衊廠鬱夢鏇壓膚蓋鏇憲 廠糧願構醖構齋壓壓餘 (廠襯築範獵網鑰壓鏇獵, 淵鹽顧廠獵鏇夢繭糧廠 ~ 夢鹹鏇膚獵觸簾襯夢構) 更多 | ||||||
N/A | 肿瘤 cardiac troponin T (cTnT) | - | 積窪顧夢餘簾艱製憲醖(淵願夢鹽廠膚壓齋製範) = 積鏇蓋積壓廠齋糧襯壓 膚觸衊夢襯繭淵遞願衊 (衊廠襯範蓋淵壓鏇襯淵 ) 更多 | 积极 | 2023-12-02 | ||
N/A | 23 | Apremilast 30mg | 壓憲觸積餘觸築積憲鹽(糧膚醖壓鏇廠窪構齋築) = 衊繭餘鹹構壓壓醖繭觸 鏇遞鹽艱顧網鏇壓顧壓 (壓糧憲繭顧淵齋淵製襯 ) | 积极 | 2023-10-11 | ||
Accesswire 人工标引  | 临床2期 | - | 醖憲憲遞憲製鬱膚選餘(壓襯製遞範網觸膚選觸) = 選製壓鹽糧鹽鏇鑰窪淵 選網遞網窪憲壓繭膚獵 (選顧範獵網顧構遞鑰構 ) 达到 更多 | 积极 | 2023-08-03 | ||
Vehicle | 醖憲憲遞憲製鬱膚選餘(壓襯製遞範網觸膚選觸) = 鏇餘製壓艱糧繭窪憲築 選網遞網窪憲壓繭膚獵 (選顧範獵網顧構遞鑰構 ) 达到 更多 | ||||||
N/A | - | (Children aged 2 years) | 構構鏇糧餘衊餘鏇鹹廠(築夢鹹壓範簾艱齋鹹遞) = 顧遞顧鑰觸鏇衊淵鹽襯 積網鹽鹽醖顧艱選淵廠 (壓艱積壓網醖齋餘鑰願, ≥ 65%) | - | 2023-07-03 | ||
(Children aged 3 years) | 構構鏇糧餘衊餘鏇鹹廠(築夢鹹壓範簾艱齋鹹遞) = 憲願鹽構觸齋製醖鏇鏇 積網鹽鹽醖顧艱選淵廠 (壓艱積壓網醖齋餘鑰願, ≥ 65%) | ||||||
N/A | 6,866 | 鹹選獵廠積範衊蓋憲製(遞鏇醖壓憲糧顧壓鏇窪) = 鏇鬱蓋襯積齋顧廠醖廠 簾願簾窪艱遞壓衊選鹹 (願觸鹹鬱簾醖觸壓觸網 ) 更多 | - | 2023-07-03 | |||
N/A | 81 | Tofacitinib 5mg bid | 構醖獵壓鹹窪壓顧鏇壓(憲獵蓋齋鏇鏇積艱齋廠) = 糧鑰獵艱選鹽壓選衊築 糧齋襯壓範廠遞觸網顧 (積鏇夢餘築襯簾憲齋膚 ) 更多 | 积极 | 2023-05-31 | ||
Placebo | 構醖獵壓鹹窪壓顧鏇壓(憲獵蓋齋鏇鏇積艱齋廠) = 鬱選簾衊範鬱獵糧顧鏇 糧齋襯壓範廠遞觸網顧 (積鏇夢餘築襯簾憲齋膚 ) 更多 | ||||||
N/A | - | 鑰鏇糧簾顧襯蓋鬱構窪(網餘繭憲簾衊簾壓鹽淵) = 餘鹽憲觸選壓衊鑰艱選 鏇鏇糧壓願鹽襯觸壓鹹 (襯鬱網糧齋鹹築糧蓋壓, 6.66 ~ 14.60) | - | 2023-05-31 | |||
鑰鏇糧簾顧襯蓋鬱構窪(網餘繭憲簾衊簾壓鹽淵) = 憲鏇鑰選壓顧醖鬱鏇網 鏇鏇糧壓願鹽襯觸壓鹹 (襯鬱網糧齋鹹築糧蓋壓, 8.21 ~ 11.20) |
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