{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,3]],"date-time":"2025-10-03T08:26:45Z","timestamp":1759480005903},"reference-count":31,"publisher":"The Journal of Rheumatology","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Rheumatol"],"published-print":{"date-parts":[[2020,4]]},"abstract":"<jats:sec><jats:title>Objective.<\/jats:title><jats:p>To assess clinical benefit in patients with chronic refractory gout who did not meet the protocol-defined criteria of responders to pegloticase.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods.<\/jats:title><jats:p>This analysis used results from 2 randomized controlled trials (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"ClinicalTrials.gov\" xlink:type=\"simple\">ClinicalTrials.gov<\/jats:ext-link>: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT00325195\">NCT00325195<\/jats:ext-link>,  <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT01356498\">NCT01356498<\/jats:ext-link>) to assess the clinical efficacy in responders and nonresponders to treatment (8 mg of pegloticase every 2 weeks). Serum urate was measured before each infusion and the following were recorded: assessment of gout flares, tophus reduction, patient\u2019s global assessment (PtGA), tender and swollen joints (TJC and SJC), pain using a 100-mm visual analog scale, and a variety of patient-reported outcomes [Medical Outcomes Study Short Form-36 questionnaire physical component summary score and arthritis-specific health index (ASHI) score].<\/jats:p><\/jats:sec><jats:sec><jats:title>Results.<\/jats:title><jats:p>The analysis included 36 persistent urate responders, 49 nonresponders, and 43 patients who received placebo. Results for both responders and nonresponders indicated significant reduction in tophi and improvements from baseline in PtGA, TJC, SJC, pain, and ASHI. No significant improvements were observed in the patients who received placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion.<\/jats:title><jats:p>Chronic refractory gout patients not achieving protocol-defined persistent urate lowering still achieve significant clinical benefits with pegloticase treatment, suggesting that transient reduction in serum urate may result in sustained clinical benefit.<\/jats:p><\/jats:sec>","DOI":"10.3899\/jrheum.190161","type":"journal-article","created":{"date-parts":[[2019,6,15]],"date-time":"2019-06-15T16:24:08Z","timestamp":1560615848000},"page":"605-612","source":"Crossref","is-referenced-by-count":3,"title":["Dissociation Between Clinical Benefit and Persistent Urate Lowering in Patients with Chronic Refractory Gout Treated with Pegloticase"],"prefix":"10.3899","volume":"47","author":[{"given":"Michael H.","family":"Pillinger","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Theodore R.","family":"Fields","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anthony E.","family":"Yeo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter E.","family":"Lipsky","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2262","published-online":{"date-parts":[[2019,6,15]]},"reference":[{"key":"2021110311500899000_47.4.605.1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.21772"},{"key":"2021110311500899000_47.4.605.2","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-209707"},{"key":"2021110311500899000_47.4.605.3","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-203325"},{"key":"2021110311500899000_47.4.605.4","doi-asserted-by":"crossref","first-page":"400","DOI":"10.1007\/s11926-013-0400-9","article-title":"The crystallization of monosodium urate","volume":"16","author":"Martillo","year":"2014","journal-title":"Curr Rheumatol Rep"},{"key":"2021110311500899000_47.4.605.5","doi-asserted-by":"publisher","DOI":"10.1002\/art.23007"},{"key":"2021110311500899000_47.4.605.6","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2011.1169"},{"key":"2021110311500899000_47.4.605.7","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2010.144022"},{"key":"2021110311500899000_47.4.605.8","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.111375"},{"key":"2021110311500899000_47.4.605.9","doi-asserted-by":"crossref","first-page":"1885","DOI":"10.1007\/s10067-018-4065-7","article-title":"Improvement in OMERACT domains and renal function with regular treatment for gout: a 12-month follow-up cohort study","volume":"37","author":"Vazquez-Mellado","year":"2018","journal-title":"Clin Rheumatol"},{"key":"2021110311500899000_47.4.605.10","unstructured":"U.S. Food and Drug Administration . 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