Long-term safety of pegloticase in chronic gout refractory to conventional treatment

被引:118
作者
Becker, Michael A. [1 ]
Baraf, Herbert S. B. [2 ]
Yood, Robert A. [3 ]
Dillon, Aileen [4 ]
Vazquez-Mellado, Janitzia [5 ]
Ottery, Faith D. [6 ]
Khanna, Dinesh [7 ]
Sundy, John S. [8 ]
机构
[1] Univ Chicago, Rheumatol Sect, Chicago, IL 60637 USA
[2] Ctr Rheumatol & Bone Res, Wheaton, MD USA
[3] Reliant Med Grp, Worcester, MA USA
[4] Kaiser Permanente Med Ctr, Rheumatol Sect, San Francisco, CA USA
[5] Hosp Gen Mexico City, Dept Rheumatol, Mexico City, DF, Mexico
[6] Savient Pharmaceut Inc, East Brunswick, NJ USA
[7] Univ Michigan, Dept Med, Ann Arbor, MI 48109 USA
[8] Duke Univ, Med Ctr, Duke Clin Res Unit, Durham, NC USA
关键词
Gout; Treatment; Rheumatoid Arthritis;
D O I
10.1136/annrheumdis-2012-201795
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
Objective To evaluate the long-term safety (up to 3years) of treatment with pegloticase in patients with refractory chronic gout. Methods 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 8mg every 2weeks (biweekly) or every 4weeks (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. Results Patients (n=149) received a mean +/- SD of 28 +/- 18 pegloticase infusions and were followed for a mean of 25 +/- 11months. 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 6mg/dl. Plasma and serum uric acid levels remained <6mg/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. Conclusions The safety profile of long-term pegloticase treatment was consistent with that observed during 6months 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 2.5years of additional treatment.
引用
收藏
页码:1469 / 1474
页数:6
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