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Real-world patterns of pegloticase use for treatment of gout: descriptive multidatabase cohort study

ObjectivePegloticase is used in severe refractory gout or in cases of intolerance to other urate-lowering therapies. We sought to evaluate the patterns of pegloticase use in the USA and the incidence of safety outcomes.MethodsWe conducted a retrospective descriptive study using data from two US comm...

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Published in:BMJ open 2020-12, Vol.10 (12), p.e041167
Main Authors: Chen, Sarah K, Liu, Jun, Kim, Seoyoung C
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description ObjectivePegloticase is used in severe refractory gout or in cases of intolerance to other urate-lowering therapies. We sought to evaluate the patterns of pegloticase use in the USA and the incidence of safety outcomes.MethodsWe conducted a retrospective descriptive study using data from two US commercial insurance claims databases (2010–2018). We identified new initiators of pegloticase with ≥1 gout diagnosis code in the 365-day baseline period prior to pegloticase initiation. We measured the number and duration of pegloticase infusions. We assessed the risk of anaphylaxis or anaphylactoid reactions, cardiovascular events, including myocardial infarction or stroke, and hospitalisation for heart failure (new onset or exacerbations) while undergoing pegloticase therapy.ResultsAmong 2.9 million patients with ≥1 diagnosis of gout, we identified only 483 (179 in Optum and 304 in MarketScan) pegloticase initiators. The mean age and % female was 55.6 years, 10.9% for MarketScan and 60.6 years and 17.3% for Optum. Hypertension was present in up to 85%, diabetes mellitus in 38%, chronic kidney disease in 46% and heart failure in 21% of the patients. The median number of infusions was four and the duration of therapy was 3 months. During the mean 0.5-year follow-up time on pegloticase, there were 3 (0.6%) anaphylaxis, 7 (1.4%) composite cardiovascular, 31 (6.4%) heart failure hospitalisations and 3 (0.6%) deaths.ConclusionPegloticase is rarely used in gout, and the median duration of pegloticase therapy was 3 months. There were few anaphylaxis events captured in this claims-based study, while heart failure hospitalisations were common.
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We sought to evaluate the patterns of pegloticase use in the USA and the incidence of safety outcomes.MethodsWe conducted a retrospective descriptive study using data from two US commercial insurance claims databases (2010–2018). We identified new initiators of pegloticase with ≥1 gout diagnosis code in the 365-day baseline period prior to pegloticase initiation. We measured the number and duration of pegloticase infusions. We assessed the risk of anaphylaxis or anaphylactoid reactions, cardiovascular events, including myocardial infarction or stroke, and hospitalisation for heart failure (new onset or exacerbations) while undergoing pegloticase therapy.ResultsAmong 2.9 million patients with ≥1 diagnosis of gout, we identified only 483 (179 in Optum and 304 in MarketScan) pegloticase initiators. The mean age and % female was 55.6 years, 10.9% for MarketScan and 60.6 years and 17.3% for Optum. Hypertension was present in up to 85%, diabetes mellitus in 38%, chronic kidney disease in 46% and heart failure in 21% of the patients. The median number of infusions was four and the duration of therapy was 3 months. During the mean 0.5-year follow-up time on pegloticase, there were 3 (0.6%) anaphylaxis, 7 (1.4%) composite cardiovascular, 31 (6.4%) heart failure hospitalisations and 3 (0.6%) deaths.ConclusionPegloticase is rarely used in gout, and the median duration of pegloticase therapy was 3 months. There were few anaphylaxis events captured in this claims-based study, while heart failure hospitalisations were common.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2020-041167</identifier><identifier>PMID: 33293318</identifier><language>eng</language><publisher>England: British Medical Journal Publishing Group</publisher><subject>Age ; Anaphylaxis ; Arthritis ; Cardiovascular disease ; Codes ; Cohort analysis ; Cohort Studies ; Diabetes ; Drug dosages ; Epidemiology ; Female ; general medicine (see internal medicine) ; Gout - drug therapy ; Gout - epidemiology ; Gout Suppressants - adverse effects ; Heart failure ; Humans ; Hypertension ; Insurance claims ; Kidney diseases ; Laboratories ; Male ; Middle Aged ; Patients ; Polyethylene Glycols - adverse effects ; Prescription drugs ; Retrospective Studies ; Rheumatism ; Rheumatology ; Urate Oxidase - adverse effects ; Uric Acid</subject><ispartof>BMJ open, 2020-12, Vol.10 (12), p.e041167</ispartof><rights>Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2020 Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b578t-a58f489cc5248ce97c9b671d93152273172043fa84d912026a7781ab505f91653</citedby><cites>FETCH-LOGICAL-b578t-a58f489cc5248ce97c9b671d93152273172043fa84d912026a7781ab505f91653</cites><orcidid>0000-0002-2517-3579</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2467772633/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2467772633?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>112,113,230,314,723,776,780,881,3180,25732,27528,27529,27903,27904,36991,44569,53769,53771,55319,55328,74872,77340,77341,77342,77343,77347,77378,77406,77432</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33293318$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chen, Sarah K</creatorcontrib><creatorcontrib>Liu, Jun</creatorcontrib><creatorcontrib>Kim, Seoyoung C</creatorcontrib><title>Real-world patterns of pegloticase use for treatment of gout: descriptive multidatabase cohort study</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><addtitle>BMJ Open</addtitle><description>ObjectivePegloticase is used in severe refractory gout or in cases of intolerance to other urate-lowering therapies. We sought to evaluate the patterns of pegloticase use in the USA and the incidence of safety outcomes.MethodsWe conducted a retrospective descriptive study using data from two US commercial insurance claims databases (2010–2018). We identified new initiators of pegloticase with ≥1 gout diagnosis code in the 365-day baseline period prior to pegloticase initiation. We measured the number and duration of pegloticase infusions. We assessed the risk of anaphylaxis or anaphylactoid reactions, cardiovascular events, including myocardial infarction or stroke, and hospitalisation for heart failure (new onset or exacerbations) while undergoing pegloticase therapy.ResultsAmong 2.9 million patients with ≥1 diagnosis of gout, we identified only 483 (179 in Optum and 304 in MarketScan) pegloticase initiators. The mean age and % female was 55.6 years, 10.9% for MarketScan and 60.6 years and 17.3% for Optum. Hypertension was present in up to 85%, diabetes mellitus in 38%, chronic kidney disease in 46% and heart failure in 21% of the patients. The median number of infusions was four and the duration of therapy was 3 months. During the mean 0.5-year follow-up time on pegloticase, there were 3 (0.6%) anaphylaxis, 7 (1.4%) composite cardiovascular, 31 (6.4%) heart failure hospitalisations and 3 (0.6%) deaths.ConclusionPegloticase is rarely used in gout, and the median duration of pegloticase therapy was 3 months. 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Liu, Jun ; Kim, Seoyoung C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b578t-a58f489cc5248ce97c9b671d93152273172043fa84d912026a7781ab505f91653</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Age</topic><topic>Anaphylaxis</topic><topic>Arthritis</topic><topic>Cardiovascular disease</topic><topic>Codes</topic><topic>Cohort analysis</topic><topic>Cohort Studies</topic><topic>Diabetes</topic><topic>Drug dosages</topic><topic>Epidemiology</topic><topic>Female</topic><topic>general medicine (see internal medicine)</topic><topic>Gout - drug therapy</topic><topic>Gout - epidemiology</topic><topic>Gout Suppressants - adverse effects</topic><topic>Heart failure</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Insurance claims</topic><topic>Kidney diseases</topic><topic>Laboratories</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Patients</topic><topic>Polyethylene Glycols - adverse effects</topic><topic>Prescription drugs</topic><topic>Retrospective Studies</topic><topic>Rheumatism</topic><topic>Rheumatology</topic><topic>Urate Oxidase - adverse effects</topic><topic>Uric Acid</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chen, Sarah K</creatorcontrib><creatorcontrib>Liu, Jun</creatorcontrib><creatorcontrib>Kim, Seoyoung C</creatorcontrib><collection>BMJ Journals (Open Access)</collection><collection>BMJ Journals:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing &amp; 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>Directory of Open Access Journals</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chen, Sarah K</au><au>Liu, Jun</au><au>Kim, Seoyoung C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Real-world patterns of pegloticase use for treatment of gout: descriptive multidatabase cohort study</atitle><jtitle>BMJ open</jtitle><stitle>BMJ Open</stitle><addtitle>BMJ Open</addtitle><date>2020-12-07</date><risdate>2020</risdate><volume>10</volume><issue>12</issue><spage>e041167</spage><pages>e041167-</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>ObjectivePegloticase is used in severe refractory gout or in cases of intolerance to other urate-lowering therapies. We sought to evaluate the patterns of pegloticase use in the USA and the incidence of safety outcomes.MethodsWe conducted a retrospective descriptive study using data from two US commercial insurance claims databases (2010–2018). We identified new initiators of pegloticase with ≥1 gout diagnosis code in the 365-day baseline period prior to pegloticase initiation. We measured the number and duration of pegloticase infusions. We assessed the risk of anaphylaxis or anaphylactoid reactions, cardiovascular events, including myocardial infarction or stroke, and hospitalisation for heart failure (new onset or exacerbations) while undergoing pegloticase therapy.ResultsAmong 2.9 million patients with ≥1 diagnosis of gout, we identified only 483 (179 in Optum and 304 in MarketScan) pegloticase initiators. The mean age and % female was 55.6 years, 10.9% for MarketScan and 60.6 years and 17.3% for Optum. Hypertension was present in up to 85%, diabetes mellitus in 38%, chronic kidney disease in 46% and heart failure in 21% of the patients. The median number of infusions was four and the duration of therapy was 3 months. During the mean 0.5-year follow-up time on pegloticase, there were 3 (0.6%) anaphylaxis, 7 (1.4%) composite cardiovascular, 31 (6.4%) heart failure hospitalisations and 3 (0.6%) deaths.ConclusionPegloticase is rarely used in gout, and the median duration of pegloticase therapy was 3 months. There were few anaphylaxis events captured in this claims-based study, while heart failure hospitalisations were common.</abstract><cop>England</cop><pub>British Medical Journal Publishing Group</pub><pmid>33293318</pmid><doi>10.1136/bmjopen-2020-041167</doi><orcidid>https://orcid.org/0000-0002-2517-3579</orcidid><oa>free_for_read</oa></addata></record>
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subjects Age
Anaphylaxis
Arthritis
Cardiovascular disease
Codes
Cohort analysis
Cohort Studies
Diabetes
Drug dosages
Epidemiology
Female
general medicine (see internal medicine)
Gout - drug therapy
Gout - epidemiology
Gout Suppressants - adverse effects
Heart failure
Humans
Hypertension
Insurance claims
Kidney diseases
Laboratories
Male
Middle Aged
Patients
Polyethylene Glycols - adverse effects
Prescription drugs
Retrospective Studies
Rheumatism
Rheumatology
Urate Oxidase - adverse effects
Uric Acid
title Real-world patterns of pegloticase use for treatment of gout: descriptive multidatabase cohort study
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