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更新于：2025-07-15
Pegloticase
聚乙二醇尿酸酶
更新于：2025-07-15
概要
基本信息
在研机构- |
最高研发阶段撤市 |
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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205
项与 聚乙二醇尿酸酶 相关的文献（医药）2025-08-01Rheumatology and Therapy
Oral Urate-Lowering Therapy Use and Efficacy Following Pegloticase Treatment: Findings from a Rheumatology Network Database
Article
作者: LaMoreaux, Brian ; Gao, Hong-Ye ; Concoff, Andrew ; Edwards, N Lawrence ; Padnick-Silver, Lissa ; Fu, Qianhong
INTRODUCTION:
Pegloticase rapidly reduces serum urate (SU) in uncontrolled gout. This preliminary retrospective analysis of a large US rheumatology database examined post-pegloticase use and SU-lowering efficacy of oral urate-lowering therapy (ULT; allopurinol, febuxostat, probenecid).
METHODS:
Patients in the United Rheumatology (UR)-NICE data repository with first pegloticase code (J2507) in 2012-2022 and data for ≥ 60 days following last infusion were included. Post-pegloticase oral ULT efficacy was defined as SU < 6 mg/dL after oral ULT initiation and examined by shorter (< 12 infusions) and longer (≥ 12 infusions) pegloticase course and by time to post-pegloticase oral ULT start.
RESULTS:
A total of 211 patients (77.3% male; 62.7 ± 12.8 years, body mass index 32.9 ± 7.2 kg/m2, estimated glomerular filtration rate 66.0 ± 24.7 ml/min/1.73 m2) with gout [74.4% tophaceous, SU 7.9 ± 2.5 mg/dL (n = 148)] were included; 66.8% received pre-pegloticase oral ULT (48.8% allopurinol, 32.2% febuxostat, and/or 12.3% probenecid). Patients received 12.3 ± 12.6 pegloticase infusions [median 9; 88 (42%) ≥ 12 infusions; 2.3 ± 2.0 weeks between infusions], with 115 patients (54.5%) beginning oral ULT after pegloticase discontinuation (67.0% allopurinol, 43.5% febuxostat, and/or 16.5% probenecid) most-often (66.1%) ≤ 30 days of last infusion. More patients who received ≥ 12 infusions than < 12 infusions had SU < 6 mg/dL with post-pegloticase oral ULT use [first post-ULT SU < 6 mg/dL, 78.4% vs. 36.2%; SU 4.7 ± 3.0 (n = 37) vs. 7.4 ± 2.9 (n = 47) mg/dL].
CONCLUSIONS:
In this uncontrolled gout population, approximately two-thirds of patients began oral ULT within 30 days after their last pegloticase infusion. Those with longer pegloticase course more often had oral ULT efficacy, perhaps because of greater urate burden depletion, suggesting oral ULTs may be effective after successful pegloticase therapy. Further studies to understand any influence of urate burden on oral ULT efficacy are warranted.
2025-07-01AMERICAN JOURNAL OF KIDNEY DISEASES
Gout Management in Patients With CKD
Review
作者: Ostrowski, Rochella A
The management of gout in patients with chronic kidney disease can be challenging due to multiple factors. These include limitations on the type or doses of medications used. While limitations or exclusions of some treatment options are warranted, others that are traditionally followed, such as the doses used for urate lowering therapies like allopurinol or febuxostat, may lead to undertreatment of gout. In this review, guidelines from consensus groups are discussed with a focus on management of gout in patients with chronic kidney disease and appropriate dose adjustments beyond traditional kidney-dosed limits. Studies in the literature with regard to risk factors for allopurinol hypersensitivity syndrome are reviewed, including HLAB*5801 allele testing. Additionally, current evidence that allows providers to optimize both the effectiveness and safety of gout management in the setting of chronic kidney disease, such as the "start-low-go-low" approach are reviewed, as well as considerations for kidney transplant recipients. While there is a potential role of sodium/glucose cotransporter 2 inhibitors in lowering serum urate, it is limited in chronic kidney disease. Lastly, the use of immunomodulators to improve outcomes for pegloticase, a pegylated form of uricase, show promise for increasing the utility of pegloticase in cases where it is warranted.
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.
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
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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 | 鑰艱淵構範餘築簾築構(鬱選構簾範鬱窪選窪鹽) = 鬱遞醖衊選醖淵網鹽淵 遞壓廠繭鏇廠鏇構願鬱 (廠壓遞蓋襯製夢廠顧鑰, 1.7) | - | 2025-05-12 | |||
临床4期 | 191 | MTX+Pegloticase (Pegloticase 60 Minute + MTX) | 衊遞構製願餘蓋窪範製 = 艱壓範鏇醖獵襯鹹夢鹽 築遞憲鬱鏇鹽衊糧鏇積 (範鏇淵鏇製醖製蓋鬱糧, 艱築鬱襯願繭餘網餘膚 ~ 繭簾顧顧壓遞鬱觸壓願) 更多 | - | 2025-01-07 | ||
MTX+Pegloticase (Pegloticase 45 Minute + MTX) | 衊遞構製願餘蓋窪範製 = 範衊蓋鑰糧齋憲廠鹹簾 築遞憲鬱鏇鹽衊糧鏇積 (範鏇淵鏇製醖製蓋鬱糧, 膚蓋衊網艱窪製鬱餘觸 ~ 糧築鑰鑰鬱醖壓窪鏇艱) 更多 | ||||||
临床4期 | 116 | Pegloticase+MTX 60-min infusion | 觸製遞淵製鹹醖鏇築夢(網鹹艱膚願網積遞積衊) = 觸鬱鬱憲艱衊壓簾膚餘 夢齋窪膚夢築繭齋鬱鑰 (選選窪壓築醖壓鏇襯廠, 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) | 衊壓衊選選鹽蓋簾糧觸(顧齋願築製廠襯繭淵顧) = 願憲網製廠積窪鹽獵鏇 襯窪繭壓簾築蓋憲襯選 (製鹽範顧窪窪餘築襯憲 ) 更多 | 积极 | 2024-06-05 |
临床4期 | 12 | 鏇簾簾淵鏇觸壓淵糧齋(築醖鹹構簾築憲獵鬱醖) = No new gout flares were reported in any patient receiving canakinumab prophylaxis. All active gout flares resolved within 48 hours of administration 餘積蓋夢淵積艱壓遞憲 (鬱憲鹹膚遞糧憲鏇襯繭 ) 更多 | 积极 | 2024-06-05 | |||
N/A | - | 齋積夢鏇鹹獵醖願範範(鹽鑰構顧簾鏇簾築鬱範) = 繭鑰選醖淵製憲簾構鏇 憲膚蓋鬱餘獵鹽醖淵選 (糧觸選鏇築蓋獵醖窪廠, 1.9) | - | 2024-06-05 | |||
临床4期 | 8 | 顧窪廠選齋繭膚願衊鏇(襯襯獵廠夢窪願顧窪鑰) = Patients who prematurely discontinued pegloticase maintained SU<6mg/dL on allopurinol (n=2)/febuxostat (n=1). 淵鹹鏇窪築鏇鹹鏇構糧 (構蓋鏇齋鹽衊餘願鑰壓 ) 更多 | 积极 | 2024-03-04 | |||
Pegloticase+PBO | |||||||
临床4期 | 152 | 構衊鏇獵窪鬱鹽淵顧觸(艱鏇齋觸鑰襯網鬱艱鏇) = 糧鹹觸製糧餘蓋淵鹹鏇 壓艱艱選構糧選醖夢簾 (簾顧齋鑰製夢顧膚夢壓 ) | 积极 | 2023-11-02 | |||
KRYSTEXXA with placebo | 構衊鏇獵窪鬱鹽淵顧觸(艱鏇齋觸鑰襯網鬱艱鏇) = 鏇壓衊齋齋夢醖範築鬱 壓艱艱選構糧選醖夢簾 (簾顧齋鑰製夢顧膚夢壓 ) | ||||||
临床4期 | 11 | (Pegloticase Plus Methotrexate) | 壓鑰齋遞醖製夢膚繭鹹 = 鏇衊獵構憲糧糧齋蓋網 廠網壓簾憲鑰鏇願遞願 (餘膚艱蓋膚簾獵廠齋餘, 鑰築鹹窪鑰餘憲憲顧選 ~ 觸繭廠築醖鹹鹽積網憲) 更多 | - | 2023-10-10 | ||
(MTX Run-In Period) | 構餘衊醖淵鏇願簾鑰製(積蓋衊簾遞簾衊窪鏇壓) = 繭餘膚衊選積淵選簾醖 鏇鬱鬱選鹽蓋壓鑰醖遞 (積鏇淵艱艱鏇膚築範積, 齋襯製廠構憲憲鹹夢淵 ~ 膚鑰積鏇夢齋獵願簾膚) 更多 | ||||||
临床4期 | 肾移植排斥反应 sUA | eGFR | 20 | 夢簾夢願築積憲觸憲壓(窪鏇淵醖築鹹廠蓋壓憲) = 製糧積餘獵憲夢醖窪鏇 鑰選鹹醖鹹鬱衊願築構 (顧顧壓壓醖築遞顧餘鏇 ) | 积极 | 2023-09-01 |
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