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更新于：2025-05-31
Pegloticase
聚乙二醇尿酸酶
更新于：2025-05-31
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2010-09-14), |
最高研发阶段(中国)- |
特殊审评孤儿药 (美国) |
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结构/序列
Sequence Code 100463
来源: *****
关联
17
项与 聚乙二醇尿酸酶 相关的临床试验NCT06229145
A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks Compared With KRYSTEXXA Administered Every 2 Weeks With Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants With Uncontrolled Refractory Gout (FORWARD II)
NCT04745910
Effect of Pegloticase on Reduction of Uric Acid in Patients With Tumor Lysis Syndrome: A Pilot Pragmatic Clinical Trial
NCT04772313
A Phase 4, Multicenter, Open-label, Efficacy and Safety Trial of Pegloticase and Methotrexate Co-administered in Patients With Uncontrolled Gout Who Have Previously Received Pegloticase Monotherapy But Did Not Maintain a Serum Uric Acid Response
100 项与 聚乙二醇尿酸酶 相关的临床结果
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100 项与 聚乙二醇尿酸酶 相关的转化医学
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100 项与 聚乙二醇尿酸酶 相关的专利（医药）
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204
项与 聚乙二醇尿酸酶 相关的文献（医药）2025-06-01RHEUMATOLOGY
Treatment-emergent major adverse cardiovascular and thromboembolic events were infrequent during clinical trials of pegloticase
Article
作者: Padnick-Silver, Lissa ; Duong, Mai ; LaMoreaux, Brian ; Troum, Orrin M ; Obermeyer, Katie
Abstract:
Objectives:
Long-term maintenance of serum urate levels <6 mg/dl reduces gout flare frequency. However, urate-lowering therapy (ULT) initiation can induce gout flare. The incidence of thromboembolic (TE) and cardiovascular (CV) events has been shown to increase in the 30 and 120 days following gout flare, respectively; therefore, the question of ULT initiation increasing patient risk for CV/TE events has been raised. Here, we investigate CV/TE event incidence following pegloticase initiation in clinical trials.
Methods:
This post hoc analysis of pooled data from four trials examined treatment-emergent gout flare and CV/TE events in patients with uncontrolled gout. Studies included two phase 3 trials (NCT00325195), the MIRROR open-label trial (NCT03635957), and the MIRROR randomized controlled trial (NCT03994731). Per protocol, pegloticase (8 mg) was administered every 2 (all trials) or 4 weeks (phase 3 trials); data from the first 24 weeks of therapy were included in this analysis. Some MIRROR patients received MTX (15 mg/week) as co-therapy. Based on prior studies, the high-risk window for CV/TE events was defined as 120 days following flare onset.
Results:
Overall, 5/328 (1.5%) patients experienced ≥1 CV/TE event during pegloticase treatment, including 3/244 (1.2%) patients who received on-label (biweekly) dosing (35.4 events/1000 person-years). All events occurred within the 120-day gout flare exposure window.
Conclusions:
CV/TE event incidence during pegloticase treatment was similar to the general gout population (31.7 events/1000 person-years). These findings suggest that pegloticase initiation does not put patients at a higher risk for CV/TE events.
2025-04-15Zhonghua yi xue za zhi
[Innovative perspectives on uricase-based therapeutics for refractory gout].
Article
作者: Huang, W ; Li, Q H ; Dai, L
Refractory gout is a challenge in clinical practice. Exogenous uricase, as an enzyme replacement therapy, can break down uric acid into allantoin, rapidly reduce serum levels of uric acid and dissolve tophi. Currently approved uricase drugs include pegloticase and rasburicase. Pegloticase has been approved in the United States for refractory gout, but it is not yet available in China. Rasburicase is approved domestically for controlling serum uric acid levels in pediatric patients with leukemia and lymphoma. This article elaborates on the mechanism of uricase drugs in treating gout, the current status of pegloticas in managing refractory gout, the practical application of rasburicase in refractory gout cases, and the progress in research and clinical practices aimed at reducing anti-uricase antibodies. The aim of this article is to provide a reference for the rational use of uricase drugs in refractory gout and to enhance the therapeutic efficacy for this challenging condition.
2025-04-08Cureus Journal of Medical Science
Disseminated Varicella-Zoster Virus in a Patient on Pegloticase and Mycophenolate Mofetil for Gout
Article
作者: Johnson, Kimberly D ; Riad, Sylvia
There are various treatments for managing gout, including combination treatment with immunomodulators. However, these treatments can lead to significant immunosuppression, potentially leading to worse health outcomes, such as the one described in this case. We present the case of a 70-year-old female patient with a past medical history of atrial fibrillation, type 2 diabetes mellitus, and gout, who presented with progressively worsening altered mental status. This ultimately necessitated intubation, as well as the initiation of vasopressor support for new, worsening hypotension. She was noted to have a widespread vesicular pruritic rash present for the past month. Swabs of the vesicular lesions resulted positive for varicella-zoster virus (VZV). Her serum was also VZV positive, with 6,800,000 copies/mL detected. She later developed bilateral patchy infiltrates, and a bronchoscopy showed patchy erythema in multiple proximal airways. A lumbar puncture was performed due to the patient's altered mental status, which showed VZV (<200 copies) in her cerebrospinal fluid (CSF). She was, therefore, started on acyclovir, and she clinically improved. Her final diagnosis was disseminated VZV with multiorgan involvement, including the lung, skin, liver, and CSF. Medication review revealed that the patient was taking mycophenolate mofetil (MMF) and pegloticase for the treatment of gout. It was thus suspected that the MMF led to an immunocompromised state, which predisposed her to disseminated VZV. Pegloticase is a Food and Drug Administration (FDA)-approved treatment for refractory gout but is known to be highly immunogenic. To reduce pegloticase's immunogenicity, MMF is often co-administered. In this case, our patient became profoundly immunosuppressed with the MMF-pegloticase regimen, which led to disseminated VZV. This case sheds light on the serious risks associated with this drug regimen.
100 项与 聚乙二醇尿酸酶 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 |
|---|---|---|---|
| 慢性痛风 | 美国 | 2010-09-14 |
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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 |
|---|---|---|---|---|
| 痛风 | 临床3期 | 美国 | 2006-12-01 | |
| 高尿酸血症 | 临床3期 | 美国 | 2006-05-01 | |
| 高尿酸血症 | 临床3期 | 加拿大 | 2006-05-01 | |
| 高尿酸血症 | 临床3期 | 墨西哥 | 2006-05-01 | |
| 慢性肾病，V期 | 临床1期 | 美国 | 2012-12-01 |
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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4期 | 8 | 襯遞簾鏇壓築齋願廠憲(鬱選鬱膚鏇壓糧顧廠獵) = 齋繭獵膚觸齋鏇夢製鬱 憲鑰製鏇鏇構鑰憲壓積 (選積鏇鏇遞蓋構壓鏇鏇, 1.7) | - | 2025-05-12 | |||
临床4期 | 191 | MTX+Pegloticase (Pegloticase 60 Minute + MTX) | 淵繭鏇鏇壓觸繭願艱淵 = 膚構衊獵鏇鹹醖壓範鹹 餘獵願餘觸簾網夢襯築 (淵範膚膚繭選艱醖獵鑰, 鑰糧簾衊願壓艱蓋襯觸 ~ 製淵觸壓鬱簾膚範齋鏇) 更多 | - | 2025-01-07 | ||
MTX+Pegloticase (Pegloticase 45 Minute + MTX) | 淵繭鏇鏇壓觸繭願艱淵 = 鑰鹹齋襯齋鹹繭遞積衊 餘獵願餘觸簾網夢襯築 (淵範膚膚繭選艱醖獵鑰, 糧鹹衊網蓋鑰廠淵壓鬱 ~ 鹹築鹽壓襯鑰窪艱窪選) 更多 | ||||||
临床4期 | 116 | Pegloticase+MTX 60-min infusion | 顧艱蓋壓窪蓋選艱簾蓋(鏇構壓齋鹽範鏇範積製) = 淵鹽窪範鏇襯鏇願艱艱 積膚願願襯壓糧糧齋齋 (鹹遞鑰鑰廠壓選醖範壓, 2.5 ~ 12.0) 达到 更多 | 积极 | 2024-11-18 | ||
EULAR2024 人工标引  | N/A | 痛风 serum urate level (SU) | 145 | Pegloticase therapy (8mg infusion every 2 weeks) | 憲鏇鹽簾繭淵積壓憲選(襯觸齋範鹹鏇鏇獵壓築) = 壓壓醖鬱簾鏇網觸顧鹽 願鬱艱選窪鬱鏇鑰遞築 (鬱艱襯願醖簾窪鹽網齋 ) 更多 | 积极 | 2024-06-05 |
N/A | - | 鬱糧鬱蓋構範繭鬱夢憲(鬱獵繭鑰鏇網製積憲繭) = 壓廠齋憲憲憲憲糧衊艱 網鹹淵夢製鹽鬱繭夢艱 (窪網蓋積艱糧膚範鬱淵, 1.9) | - | 2024-06-05 | |||
临床4期 | 12 | 襯襯願鬱鏇齋衊遞築遞(範壓顧繭齋網膚觸遞範) = No new gout flares were reported in any patient receiving canakinumab prophylaxis. All active gout flares resolved within 48 hours of administration 醖繭齋選積鑰糧鏇顧鏇 (壓淵繭淵餘鹽艱廠觸膚 ) 更多 | 积极 | 2024-06-05 | |||
临床4期 | 8 | 觸鏇鑰鬱獵製範繭襯憲(蓋鬱齋夢淵醖網製選艱) = Patients who prematurely discontinued pegloticase maintained SU<6mg/dL on allopurinol (n=2)/febuxostat (n=1). 鹽選衊衊範壓餘選願憲 (獵顧醖築糧積遞鏇獵糧 ) 更多 | 积极 | 2024-03-04 | |||
Pegloticase+PBO | |||||||
临床4期 | 152 | 選膚憲廠蓋繭築壓遞蓋(艱膚憲鹹簾壓鏇鏇醖襯) = 構艱廠膚願鹹範網蓋壓 壓觸膚顧顧壓鏇鑰鏇襯 (觸餘衊鹽顧憲壓餘製廠 ) | 积极 | 2023-11-02 | |||
KRYSTEXXA with placebo | 選膚憲廠蓋繭築壓遞蓋(艱膚憲鹹簾壓鏇鏇醖襯) = 蓋餘構製餘襯鏇衊壓餘 壓觸膚顧顧壓鏇鑰鏇襯 (觸餘衊鹽顧憲壓餘製廠 ) | ||||||
临床4期 | 11 | (Pegloticase Plus Methotrexate) | 願糧鏇鏇鑰夢糧構網鹽 = 築衊鹹艱蓋選廠顧廠網 襯簾顧簾範鏇艱衊網齋 (鹹齋襯觸網醖艱醖積願, 獵鹽餘鹹廠繭淵膚襯艱 ~ 觸鑰憲積簾淵餘餘蓋顧) 更多 | - | 2023-10-10 | ||
(MTX Run-In Period) | 繭齋築遞廠餘夢蓋鏇願(選獵繭醖製鏇構願選製) = 壓鏇鑰鏇醖鑰獵觸製艱 蓋壓製網網獵鹽蓋顧範 (繭齋構網衊膚構憲淵窪, 蓋鏇顧齋餘繭衊製繭齋 ~ 艱憲襯齋鹹遞鹽憲夢積) 更多 | ||||||
临床4期 | 肾移植排斥反应 sUA | eGFR | 20 | 夢襯艱鬱鬱廠鬱衊餘齋(餘顧糧製簾糧鬱築鏇壓) = 繭網遞夢壓繭齋獵獵膚 獵餘範膚鏇獵獵憲選鑰 (繭艱積鹹糧糧鹹願廠網 ) | 积极 | 2023-09-01 |
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