{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T23:27:28Z","timestamp":1792106848695,"version":"4.4.0"},"reference-count":18,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2022,9,20]],"date-time":"2022-09-20T00:00:00Z","timestamp":1663632000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004328","name":"Genentech","doi-asserted-by":"publisher","award":["I#0039599"],"award-info":[{"award-number":["I#0039599"]}],"id":[{"id":"10.13039\/100004328","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["ACR Open Rheumatology"],"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the efficacy and tolerability of tocilizumab in a multicenter, randomized, double\u2010blind, placebo\u2010controlled trial in refractory adult patients with dermatomyositis (DM) and polymyositis (PM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Thirty\u2010six subjects with probable or definite DM\/PM were enrolled in a 6\u2010month phase 2B clinical trial and randomized 1:1 to receive tocilizumab (8 mg\/kg intravenously) or placebo every 4\u2009weeks for 24\u2009weeks. Eligible subjects had either a DM rash, a myositis\u2010associated autoantibody or an adjudicated PM diagnosis. Active disease was defined by at least three of six abnormal core set measures (CSMs), including a manual muscle testing (MMT)\u20108 score of less than 136\/150. If the MMT\u20108 score was greater than 136, then a cutaneous score of 3 or more (10 cm visual analogue scale) was required along with three additional abnormal CSMs indicating disease activity. The primary endpoint compared the Total Improvement Score (TIS) between both arms from week 4 to 24. Secondary outcomes included time to meeting minimal TIS improvement, changes in CSMs, time to worsening, steroid\u2010sparing effect, proportion of subjects meeting more stringent improvement criteria, and safety outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      There was no significant difference (\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.86) in the TIS over 24\u2009weeks between tocilizumab and placebo arms. The secondary endpoints of time to improvement (minimal, moderate, or major), time to worsening, CSM changes, safety outcomes, and steroid\u2010sparing effect were also not significantly different between arms.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Tocilizumab was safe and well tolerated but did not meet the primary or secondary efficacy outcomes in refractory DM and PM in this 24\u2010week phase 2B study.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/acr2.11493","type":"journal-article","created":{"date-parts":[[2022,9,21]],"date-time":"2022-09-21T02:44:19Z","timestamp":1663728259000},"page":"983-990","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":40,"title":["Randomized Trial of Tocilizumab in the Treatment of Refractory Adult Polymyositis and Dermatomyositis"],"prefix":"10.1002","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9529-3111","authenticated-orcid":false,"given":"Chester V.","family":"Oddis","sequence":"first","affiliation":[{"name":"University of Pittsburgh School of Medicine  Pittsburgh Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Howard E.","family":"Rockette","sequence":"additional","affiliation":[{"name":"University of Pittsburgh School of Medicine  Pittsburgh Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7318-4387","authenticated-orcid":false,"given":"Lei","family":"Zhu","sequence":"additional","affiliation":[{"name":"University of Pittsburgh School of Medicine  Pittsburgh Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane C.","family":"Koontz","sequence":"additional","affiliation":[{"name":"University of Pittsburgh School of Medicine  Pittsburgh 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