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dc.contributor.authorBecker, Michael A.
dc.contributor.authorBaraf, Herbert S. B.
dc.contributor.authorYood, Robert A.
dc.contributor.authorDillon, Aileen
dc.contributor.authorVazquez-Mellado, Janitzia
dc.contributor.authorOttery, Faith D.
dc.contributor.authorKhanna, Dinesh
dc.contributor.authorSundy, John S.
dc.date2022-08-11T08:09:24.000
dc.date.accessioned2022-08-23T16:29:19Z
dc.date.available2022-08-23T16:29:19Z
dc.date.issued2012-11-10
dc.date.submitted2013-01-02
dc.identifier.citation<p>Ann Rheum Dis. 2012 Dec 11. <a href="http://dx.doi.org/10.1136/annrheumdis-2012-201795" target="_blank">Link to article on publisher's site</a></p>
dc.identifier.issn0003-4967 (Linking)
dc.identifier.doi10.1136/annrheumdis-2012-201795
dc.identifier.pmid23144450
dc.identifier.urihttp://hdl.handle.net/20.500.14038/37219
dc.description.abstractOBJECTIVE: To evaluate the long-term safety (up to 3 years) 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 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. RESULTS: 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 /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 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.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=23144450&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttp://ard.bmj.com/content/early/2012/12/10/annrheumdis-2012-201795.full.pdf+html
dc.rights<p>This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ andhttp://creativecommons.org/licenses/by-nc/3.0/legalcode</p>
dc.subjectGout
dc.subjectPolyethylene Glycols
dc.subjectUrate Oxidase
dc.subjectMusculoskeletal Diseases
dc.subjectRheumatology
dc.titleLong-term safety of pegloticase in chronic gout refractory to conventional treatment
dc.typeJournal Article
dc.source.journaltitleAnnals of the rheumatic diseases
dc.identifier.legacyfulltexthttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=1935&amp;context=meyers_pp&amp;unstamped=1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/meyers_pp/637
dc.identifier.contextkey3560242
refterms.dateFOA2022-08-23T16:29:19Z
html.description.abstract<p>OBJECTIVE: To evaluate the long-term safety (up to 3 years) of treatment with pegloticase in patients with refractory chronic gout.</p> <p>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 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.</p> <p>RESULTS: 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 /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.</p> <p>CONCLUSIONS: 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.</p>
dc.identifier.submissionpathmeyers_pp/637
dc.contributor.departmentMeyers Primary Care Institute


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