{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T07:17:16Z","timestamp":1792048636272,"version":"4.4.0"},"reference-count":35,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,2,9]],"date-time":"2021-02-09T00:00:00Z","timestamp":1612828800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To report the 2\u2010year efficacy and safety of tocilizumab (TCZ) in patients with polyarticular\u2010course juvenile idiopathic arthritis (JIA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients ages 2\u201317 years with active polyarticular\u2010course JIA, in whom treatment with methotrexate was unsuccessful, received 16 weeks of open\u2010label intravenous TCZ in part 1 (once every 4 weeks: 8 mg\/kg or 10 mg\/kg for body weight [BW] &lt;30 kg; 8 mg\/kg for BW \u226530 kg). Assessments were based on the JIA\u2013American College of Rheumatology (ACR) response (defined as percentage of improvement in \u22653 of the 6 JIA core response variables [CRVs]). Patients with at least a JIA\u2010ACR30 response (defined as \u226530% improvement in \u22653 of the 6 JIA CRVs without worsening in &gt;1 of the remaining JIA CRVs by &gt;30%) at week 16 were randomly assigned (1:1) to receive TCZ or placebo in part 2. Patients remained in part 2 until either week 40 or the occurrence of JIA flare. Upon starting part 3, all patients received open\u2010label TCZ. At week 104 of the study, efficacy was assessed using JIA\u2010ACR50\/70\/90 response rates (defined as 50%, 70%, or 90% improvement, respectively), achievement of inactive disease, and the Juvenile Arthritis Disease Activity Score in 71 joints (JADAS\u201071). Safety was assessed in the all\u2010exposure population per 100 patient\u2010years of exposure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 188 patients entered part 1, 166 patients entered part 2, and 160 patients entered part 3. By week 104, among the 188 patients in the modified intent\u2010to\u2010treat group who received TCZ, JIA\u2010ACR50\/70\/90 response rates were 80.3%\/77.1%\/59.6%, respectively, the median JADAS\u201071 score decreased from 3.6 at week 40 to 0.7 at week 104, 51.1% of patients had achieved inactive disease, and 31 of 66 patients who had been receiving glucocorticoids discontinued them. Adverse event (AE) and serious AE rates were 406.5 per 100 patient\u2010years and 11.1 per 100 patient\u2010years, respectively. The infection rate was 151.4 per 100 patient\u2010years, and the serious infection rate was 5.2 per 100 patient\u2010years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Patients treated with TCZ for polyarticular\u2010course JIA showed high\u2010level disease control for up to 2 years. The TCZ safety profile was consistent with that previously reported.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.41528","type":"journal-article","created":{"date-parts":[[2020,9,20]],"date-time":"2020-09-20T04:21:13Z","timestamp":1600575673000},"page":"530-541","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":41,"title":["Efficacy and Safety of Tocilizumab for Polyarticular\u2010Course Juvenile Idiopathic Arthritis in the Open\u2010Label Two\u2010Year Extension of a Phase III Trial"],"prefix":"10.1002","volume":"73","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9478-2987","authenticated-orcid":false,"given":"Hermine I.","family":"Brunner","sequence":"first","affiliation":[{"name":"Cincinnati Children\u2019s Hospital Medical Center  Cincinnati Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8407-7782","authenticated-orcid":false,"given":"Nicolino","family":"Ruperto","sequence":"additional","affiliation":[{"name":"Istituto Giannina Gaslini Pediatria II\u2010Rheumatologia PRINTO  Genoa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zbigniew","family":"Zuber","sequence":"additional","affiliation":[{"name":"Andrzej Frycz Modrzewski Krakow University  Krakow Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rub\u00e9n","family":"Cuttica","sequence":"additional","affiliation":[{"name":"Hospital General de Ni\u00f1os Pedro de Elizalde  Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vladimir","family":"Keltsev","sequence":"additional","affiliation":[{"name":"Samara Regional Clinical Hospital  Samara Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricardo M.","family":"Xavier","sequence":"additional","affiliation":[{"name":"Hospital de Cl\u00ednicas de Porto Alegre Universidade Federal do Rio Grande do Sul  Porto Alegre Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruben","family":"Burgos\u2010Vargas","sequence":"additional","affiliation":[{"name":"Hospital General de M\u00e9xico and Universidad Nacional Aut\u00f3noma de M\u00e9xico  Mexico City Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inmaculada Calvo","family":"Penades","sequence":"additional","affiliation":[{"name":"Hospital Universitario y Polit\u00e9cnico La Fe  Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Earl D.","family":"Silverman","sequence":"additional","affiliation":[{"name":"University of Toronto  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graciela","family":"Espada","sequence":"additional","affiliation":[{"name":"Hospital de Ni\u00f1os Ricardo Gutierrez  Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel Ferrandiz","family":"Zavaler","sequence":"additional","affiliation":[{"name":"Instituto Nacional de Salud del Ni\u00f1o  Lima Peru"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7132-3390","authenticated-orcid":false,"given":"Yukiko","family":"Kimura","sequence":"additional","affiliation":[{"name":"Joseph M. 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