{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T14:34:26Z","timestamp":1791470066417,"version":"4.3.4"},"reference-count":37,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2018,5,20]],"date-time":"2018-05-20T00:00:00Z","timestamp":1526774400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002491","name":"Bristol-Myers Squibb","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002491","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2018,7]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To investigate the pharmacokinetics, effectiveness, and safety of subcutaneous (<jats:styled-content style=\"fixed-case\">SC<\/jats:styled-content>) abatacept treatment over 24 months in patients with polyarticular\u2010course juvenile idiopathic arthritis (<jats:styled-content style=\"fixed-case\">JIA<\/jats:styled-content>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this phase <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content>, open\u2010label, international, multicenter, single\u2010arm study, patients with polyarticular <jats:styled-content style=\"fixed-case\">JIA<\/jats:styled-content> (cohort 1, ages 6\u201317 years and cohort 2, ages 2\u20135 years) in whom treatment with \u22651 disease\u2010modifying antirheumatic drug was unsuccessful received weight\u2010tiered <jats:styled-content style=\"fixed-case\">SC<\/jats:styled-content> abatacept weekly: 10 to &lt;25 kg (50 mg), 25 to &lt;50 kg (87.5 mg), \u226550 kg (125 mg). Patients who had met the <jats:styled-content style=\"fixed-case\">JIA<\/jats:styled-content>\u2013American College of Rheumatology 30% improvement criteria (achieved a <jats:styled-content style=\"fixed-case\">JIA<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">ACR<\/jats:styled-content> 30 response) at month 4 were given the option to continue <jats:styled-content style=\"fixed-case\">SC<\/jats:styled-content> abatacept to month 24. The primary end point was the abatacept steady\u2010state serum trough concentration (C<jats:sub>minss<\/jats:sub>) in cohort 1 at month 4. Other outcome measures included <jats:styled-content style=\"fixed-case\">JIA<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">ACR<\/jats:styled-content> 30, 50, 70, 90, 100, and inactive disease status, the median Juvenile Arthritis Disease Activity Score in 71 joints using the C\u2010reactive protein level (<jats:styled-content style=\"fixed-case\">JADAS<\/jats:styled-content>\u201071\u2013<jats:styled-content style=\"fixed-case\">CRP<\/jats:styled-content>) over time, safety, and immunogenicity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The median abatacept C<jats:sub>minss<\/jats:sub> at month 4 (primary end point) and at month 24 was above the target therapeutic exposure (10 \u03bcg\/ml) in both cohorts. The percentage of patients who had achieved <jats:styled-content style=\"fixed-case\">JIA<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">ACR<\/jats:styled-content> 30, 50, 70, 90, or 100 responses or had inactive disease responses at month 4 (intent\u2010to\u2010treat population) was 83.2%, 72.8%, 52.6%, 28.3%, 14.5%, and 30.1%, respectively, in cohort 1 (n\u00a0=\u00a0173) and 89.1%, 84.8%, 73.9%, 58.7%, 41.3%, and 50.0%, respectively, in cohort 2 (n\u00a0= 46); the responses were maintained to month 24. The median (interquartile range) <jats:styled-content style=\"fixed-case\">JADAS<\/jats:styled-content>\u201071\u2013<jats:styled-content style=\"fixed-case\">CRP<\/jats:styled-content> improved from baseline to month 4: cohort 1, from 21.0 (13.5, 30.3) to 4.6 (2.1, 9.4); cohort 2, from 18.1 (14.0, 23.1) to 2.1 (0.3, 4.4). Improvements were sustained to month 24, at which time 27 of 173 patients (cohort 1) and 11 of 22 patients (cohort 2) had achieved <jats:styled-content style=\"fixed-case\">JADAS<\/jats:styled-content>\u201071\u2013<jats:styled-content style=\"fixed-case\">CRP<\/jats:styled-content> remission. No unexpected adverse events were reported; 4 of 172 patients (2.3%) in cohort 1 and 4 of 46 (8.7%) in cohort 2 developed anti\u2010abatacept antibodies, with no clinical effects.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Weight\u2010stratified <jats:styled-content style=\"fixed-case\">SC<\/jats:styled-content> abatacept yielded target therapeutic exposures across age and weight groups, was well tolerated, and improved polyarticular <jats:styled-content style=\"fixed-case\">JIA<\/jats:styled-content> symptoms over 24 months.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.40466","type":"journal-article","created":{"date-parts":[[2018,2,26]],"date-time":"2018-02-26T15:16:40Z","timestamp":1519658200000},"page":"1144-1154","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":69,"title":["Subcutaneous Abatacept in Patients With Polyarticular\u2010Course Juvenile Idiopathic Arthritis"],"prefix":"10.1002","volume":"70","author":[{"given":"Hermine I.","family":"Brunner","sequence":"first","affiliation":[{"name":"Cincinnati Children's Hospital Medical Center Cincinnati Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikolay","family":"Tzaribachev","sequence":"additional","affiliation":[{"name":"Pediatric Rheumatology Research Institute Bad Bramstedt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriel","family":"Vega\u2010Cornejo","sequence":"additional","affiliation":[{"name":"Hospital M\u00e9xico Americano Guadalajara Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingrid","family":"Louw","sequence":"additional","affiliation":[{"name":"Panorama Medical Centre Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto","family":"Berman","sequence":"additional","affiliation":[{"name":"Hospital Angel C. 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