Long-term safety of pegloticase in chronic gout refractory to conventional treatment.
Long-term safety of pegloticase in chronic gout refractory to conventional treatment.
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DOI：
10.1136/annrheumdis-2012-201795
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发表时间：
2013-09-01
影响因子：
27.4
通讯作者：
Sundy JS
中科院分区：
文献类型：
--
作者：
Becker MA;Baraf HS;Yood RA;Dillon A;Vázquez-Mellado J;Ottery FD;Khanna D;Sundy JS
评价pegloticase治疗难治性慢性痛风患者的长期安全性（长达3年）。 这项开放标签扩展（OLE）研究在美国、加拿大和墨西哥的46家研究中心进行。完成两项重复随机安慰剂对照6个月试验之一的患者接受pegloticase 8 mg每2周一次（每两周一次）或每4周一次（每月一次）。 安全性作为主要结局进行评价，特别关注痛风发作和输注相关反应（IR）。次要结局包括降尿酸和临床疗效。患者（n=149）接受了平均值±SD为28±18次的聚乙二醇化酶输注，并接受了平均25±11个月的随访。 痛风发作和IR是最常报告的不良事件;这些在对治疗有持续降尿酸反应的患者和接受每两周一次治疗的患者中最不常见。在11例严重IR患者中，10例在尿酸超过6 mg/dl时发生事件。 在整个OLE研究中，大多数随机对照试验（RCT）定义的pegloticase应答者的血浆和血清尿酸水平保持<6 mg/dl，并伴随痛风石消退和发作发生率的持续和进行性改善。长期pegloticase治疗的安全性特征与6个月RCT治疗期间观察到的一致;未发现新的安全性信号。 在RCT pegloticase治疗期间，在维持目标范围降尿酸应答的患者中开始的临床状态改善（以潮红和痛风石减少的形式）在长达2.5年的额外治疗期间持续或进展。
To evaluate the long-term safety (up to 3 years) of treatment with pegloticase in patients with refractory chronic gout. This open-label extension (OLE) study was conducted at 46 sites in the USA, Canada and Mexico. Patients completing either of two replicate randomised placebo-controlled 6-month trials received pegloticase 8 mg every 2 weeks (biweekly) or every 4 weeks (monthly). Safety was evaluated as the primary outcome, with special interest in gout flares and infusion-related reactions (IRs). Secondary outcomes included urate-lowering and clinical efficacy. Patients (n=149) received a mean±SD of 28±18 pegloticase infusions and were followed for a mean of 25±11 months. Gout flares and IRs were the most frequently reported adverse events; these were least common in patients with a sustained urate-lowering response to treatment and those receiving biweekly treatment. In 10 of the 11 patients with a serious IR, the event occurred when uric acid exceeded 6 mg/dl. Plasma and serum uric acid levels remained <6 mg/dl in most randomised controlled trial (RCT)-defined pegloticase responders throughout the OLE study and were accompanied by sustained and progressive improvements in tophus resolution and flare incidence. The safety profile of long-term pegloticase treatment was consistent with that observed during 6 months of RCT treatment; no new safety signals were identified. Improvements in clinical status, in the form of flare and tophus reduction initiated during RCT pegloticase treatment in patients maintaining goal range urate-lowering responses were sustained or advanced during up to 2.5 years of additional treatment.
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影响因子：
4.2
作者：
Day, Richard O.;Williams, Kenneth M.
通讯作者：
Williams, Kenneth M.
DOI：
10.1002/art.20405
发表时间：
2004-06-15
期刊：
ARTHRITIS & RHEUMATISM-ARTHRITIS CARE & RESEARCH
影响因子：
--
作者：
Shoji, A;Yamanaka, H;Kamatani, N
通讯作者：
Kamatani, N
DOI：
10.1002/art.10511
发表时间：
2002-08-15
期刊：
ARTHRITIS & RHEUMATISM-ARTHRITIS CARE & RESEARCH
影响因子：
--
作者：
Perez-Ruiz, F;Calabozo, M;Ruibal, A
通讯作者：
Ruibal, A
影响因子：
27.4
作者：
Pascual, Eliseo;Sivera, Francisca
通讯作者：
Sivera, Francisca
影响因子：
120.7
作者：
Sundy, John S.;Baraf, Herbert S. B.;Becker, Michael A.
通讯作者：
Becker, Michael A.